JUVÉDERM® VOLUMA® in Houston Heights, TX
Cheek and Chin Dermal Filler | SKNCRAFT | Houston Heights, Tx
RESTORE FACIAL BALANCE, CONTOUR & LIFT
With JUVÉDERM® VOLUMA® XC for Cheeks & Chin
As aging occurs, the cheeks and midface may flatten and the skin may begin to deflate and sag. Overtime there is a natural loss of volume in the cheek area, known as age-related midface volume loss. At the same time, the lower face and chin loose volume and may become less supportive to the entire face.
JUVÉDERM VOLUMA™ XC is approved for correction of two important facial structures: the cheek and chin. For the cheek and midface, VOLUMA adds volume back to the deep layers beneath the skin's surface, which restores lift and provides contour to the cheek. For the chin, VOLUMA provides structured support to the chin region to improve the chin profile. Adding volume to the chin area creates shape and definition and is important for framing the face.
At SKNCRAFT, we focus on facial balance. VOLUMA is our go to midface and cheek filler because it is clinically proven to provide lift and structure to the deeper layers of the skin. Our clientele love the longevity of VOLUMA for their cheeks and chin.
HOW CAN VOLUMA™ XC HELP?
Everyone wants youthful, healthy-looking skin. Smooth texture and a radiant skin tone are key to flawless skin. However as we age, it’s not just about lines and wrinkles. Our cheeks lose volume in the upper face and the skin and facial structures begin to sag. Our lower face, at the same time, loses volume and structure and ultimately provides less support to the face structures and skin. Restoring balanced volume to the upper and lower face is a key component to a beautiful face. It also makes a world of difference in the appearance of your skin. Too little volume in the cheek area can make the face look sunken and exaggerate the look of fine lines. On the other hand, too much volume can cause the skin to look swollen and unnatural.
VOLUMA HAS UNIQE PROPERTIES FOR 2 FACIAL AREAS
CHEEKS: JUVÉDERM VOLUMA™ XC is the first FDA-approved injectable gel to instantly add volume to your cheek area to correct age-related volume loss in adults over the age of 21. It can provide you contour and a subtle lift for up to two years with optimal treatment.
CHIN: JUVÉDERM® VOLUMA® XC injectable gel is designed for deep injection for augmentation of the chin region to improve the chin profile. Adding volume to the chin area creates shape and definition for adults over 21 years of age.
Botox Cosmetic, or Botulinum Toxin, is the first and only treatment FDA-approved to make temporarily moderate to severe frown lines, crow’s feet, and forehead lines look better in adults
The amount of product varies per person and will depend on your muscle's strength and aesthetic preference.
At the time of your appointment, your provider will review your dosage in depth with you.
Results can be seen within the first 24-48 hours. However, results will take full effect 14 days post-treatment
Results last up to 4 months for moderate to severe frown lines and will vary per person.
It is always recommended to plan your next treatment with your provider
Most clients think the injections feel like a light “pinch.” However, we are all about comfort and have
a high-tech chilling machine that adds extra comfort to the treatment area
Once you’ve completed a consultation, the process is quick and easy!
Your appointment will take 15 to 30 minutes max
Yes! While we always recommend speaking with your provider before scheduling,
we are more than happy to accommodate more than one treatment
Sorry, Mama! We don’t currently offer nor recommend any services that are safe if pregnant or breastfeeding.
Let us help you stay on track and create a custom treatment plan for the future.
INDICATIONS, IMPORTANT SAFETY INFORMATION, AND PRESCRIBING INFORMATION
BOTOX® Cosmetic (onabotulinumtoxinA) Important InformationIndications
BOTOX® Cosmetic (onabotulinumtoxinA) is indicated in adult patients for the temporary improvement in the appearance of:Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity
Moderate to severe lateral canthal lines associated with orbicularis oculi activity
Moderate to severe forehead lines associated with frontalis activity
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of BOTOX® Cosmetic and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.CONTRAINDICATIONS
BOTOX® Cosmetic is contraindicated in the presence of infection at the proposed injection site(s) and in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.
WARNINGS AND PRECAUTIONS
Lack of Interchangeability Between Botulinum Toxin Products
The potency units of BOTOX® Cosmetic are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of BOTOX® Cosmetic cannot be compared to nor converted into units of any other botulinum toxin products assessed with any other specific assay method.
Spread of Toxin Effect
Please refer to Boxed Warning for Distant Spread of Toxin Effect.
No definitive serious adverse event reports of distant spread of toxin effect associated with dermatologic use of BOTOX® Cosmetic at the labeled dose of 20 Units (for glabellar lines), 24 Units (for lateral canthal lines), 40 Units (for forehead lines with glabellar lines), 44 Units (for simultaneous treatment of lateral canthal lines and glabellar lines), and 64 Units (for simultaneous treatment of lateral canthal lines, glabellar lines, and forehead lines) have been reported. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX® injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities. There is insufficient information to identify factors associated with an increased risk for adverse reactions associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses have not been established.
Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft-tissue edema, and dyspnea. If such reactions occur, further injection of BOTOX® Cosmetic should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was used as the diluent and, consequently, the causal agent cannot be reliably determined.
Cardiovascular System
There have been reports following administration of BOTOX® of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including pre-existing cardiovascular disease. Use caution when administering to patients with pre-existing cardiovascular disease.
Increased Risk of Clinically Significant Effects With Pre-existing Neuromuscular Disorders
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).
Pre-existing Conditions at the Injection Site
Caution should be used when BOTOX® Cosmetic treatment is used in the presence of inflammation at the proposed injection site(s) or when excessive weakness or atrophy is present in the target muscle(s).
Dry Eye in Patients Treated With BOTOX® Cosmetic
There have been reports of dry eye associated with BOTOX® Cosmetic injection in or near the orbicularis oculi muscle. If symptoms of dry eye (eg, eye irritation, photophobia, or visual changes) persist, consider referring patients to an ophthalmologist.
Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.
ADVERSE REACTIONS
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for glabellar lines were eyelid ptosis (3%), facial pain (1%), facial paresis (1%), and muscular weakness (1%).
The most frequently reported adverse reaction following injection of BOTOX® Cosmetic for lateral canthal lines was eyelid edema (1%).
The most frequently reported adverse reactions following injection of BOTOX® Cosmetic for forehead lines with glabellar lines were headache (9%), brow ptosis (2%), and eyelid ptosis (2%).
DRUG INTERACTIONS
Co-administration of BOTOX® Cosmetic and aminoglycosides or other agents interfering with neuromuscular transmission (eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of BOTOX® Cosmetic may potentiate systemic anticholinergic effects.
The effect of administering different botulinum neurotoxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.
Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of BOTOX® Cosmetic.
USE IN SPECIFIC POPULATIONS
There are no studies or adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX® Cosmetic in pregnant women. There are no data on the presence of BOTOX® Cosmetic in human or animal milk, the effects on the breastfed child, or the effects on milk production.
Please see BOTOX® Cosmetic full Prescribing Information including Boxed Warning and Medication Guide.
The amount of product varies per person and will depend on your muscle's strength and aesthetic preference.
At the time of your appointment, your provider will review your dosage in depth with you.
Results can be seen within the first 24-48 hours. However, results will take full effect 14 days post-treatment
Results last up to 4 months for moderate to severe frown lines and will vary per person.
It is always recommended to plan your next treatment with your provider
Most clients think the injections feel like a light “pinch.” However, we are all about comfort and have
a high-tech chilling machine that adds extra comfort to the treatment area
Once you’ve completed a consultation, the process is quick and easy!
Your appointment will take 15 to 30 minutes max
Sorry, Mama! We don’t currently offer nor recommend any services that are safe if pregnant or breastfeeding.
Let us help you stay on track and create a custom treatment plan for the future.
JUVÉDERM® is the #1 chosen collection of hyaluronic acid fillers in the US*. Each product in the JUVÉDERM® Collection of Fillers adds volume to a different area of the face—without surgery. All JUVÉDERM® fillers are smooth, crystal-clear gels that are administered by injection in your aesthetic healthcare provider's office.
*December 2022 Provider Survey Data (n=938)
Different formulations are approved to either volumize cheeks, smooth smile lines, smooth lines around the mouth, plump the lips, define the chin, improve the jawline, or improve the appearance of undereye hollows. The results are long-lasting, and can be customized by your licensed specialist to help you achieve your aesthetic goals.
The JUVÉDERM® Collection of Fillers are for adults over 21.
JUVÉDERM® VOLLURE® XC softens moderate to severe facial wrinkles and folds (eg, nasolabial folds) by adding volume around the nose and mouth.
JUVÉDERM® VOLUMA® XC is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile.
JUVÉDERM® VOLBELLA® XC adds volume to the lips for a subtle plump, softens the appearance of perioral lines, and improves the appearance of undereye hollows.
JUVÉDERM® ULTRA PLUS XC smooths moderate to severe facial wrinkles and folds around your nose and mouth.
JUVÉDERM® ULTRA XC adds fullness and plumps lips as well as smooths and corrects moderate to severe wrinkles and folds in adults.
JUVÉDERM® VOLUX® XC adds volume along the jawline area to improve jawline definition in patients with moderate to severe loss. The added volume augments the shape and structure of the lower face.
Products in the JUVÉDERM® Collection are FDA approved and have been widely studied. Numerous clinical studies have been completed globally evaluating the safety and effectiveness of Vycross® technology fillers. Please see below for Important Safety Information.
Vycross® is the #1 chosen filler technology in the world. Vycross® is a proprietary technology designed by Allergan Aesthetics for use in its JUVÉDERM® Collection of hyaluronic acid (HA) fillers, including JUVÉDERM® VOLUMA® XC, JUVÉDERM® VOLLURE® XC, JUVÉDERM® VOLBELLA® XC, and JUVÉDERM® VOLUX® XC. Vycross® technology cross-links HA molecules to create a smooth and efficiently cross-linked filler. All Vycross® fillers contain a small quantity of lidocaine to decrease injection-site pain.
*December 2022 Provider Survey Data (n=938)
The JUVÉDERM® Collection of Fillers is made from hyaluronic acid (HA). HA is a natural substance in the skin that delivers nutrients, helps the skin retain moisture and softness. Each product in the JUVÉDERM® Collection of Fillers is made from a modified form of HA.
JUVÉDERM® injectable gels labeled with "XC" contain pain-reducing lidocaine to help manage pain or discomfort during the injection. You may also ask your aesthetic healthcare provider about a topical numbing cream or ice to help further minimize discomfort.
The cost not only includes the price of the product but, more importantly, the skill and expertise of the specialist or healthcare professional who is administering your treatment. Look for someone who is licensed and trained and has experience treating patients with the JUVÉDERM® Collection. Be wary of discount products or “cheap” JUVÉDERM® Collection treatments — if it sounds too good to be true, it probably is.
It is more important to find an experienced specialist who will take the time to understand your treatment goals and develop a treatment plan that is right for you.
Join Allē, the new and improved loyalty program by the makers of JUVÉDERM®, for savings on treatments within the JUVÉDERM® Collection. With Allē, you can earn 200 points for qualifying JUVÉDERM® treatments that you can redeem for savings on future treatments.
Allē also rewards you for getting a variety of in-office treatments from other brands, too. Then, redeem points for savings on your favorite Allergan Aesthetics brands. Use points as you go, or store them in your Wallet for big savings later. 100 Points = $10 toward qualifying products and treatments.
You will see results immediately/instantly.
Results may last one year to two years, with optimal treatment and depending on the formula used and the area treated. Please read each product description to see how long results last with each formula and treatment area, based on what was observed in clinical studies.
Do not receive JUVÉDERM® injectable gel fillers if you have a history of severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the proteins (Gram-positive bacterial proteins) used to make hyaluronic acid (HA) in JUVÉDERM® injectable gel fillers.
JUVÉDERM® fillers have established safety profiles. The safety and effectiveness of JUVÉDERM® fillers have been evaluated in numerous clinical studies worldwide.
Treatment with JUVÉDERM® fillers is not permanent. Depending on the JUVÉDERM® filler used and the treatment area, results may last one year to two years with optimal treatment.
The most common side effects are redness, swelling, pain, and tenderness. Minimize exercise, sun or heat exposure, and alcoholic beverages within the first 24 hours following treatment to avoid worsening these side effects. Talk to your licensed specialist about post-care instructions following treatment and please see below for more Important Safety Information.
IMPORTANT SAFETY INFORMATION
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
JUVÉDERM® Injectable Gel Fillers Important Information
ARE THERE ANY REASONS WHY I SHOULD NOT RECEIVE ANY JUVÉDERM® FORMULATION?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
WHAT WARNINGS SHOULD MY DOCTOR ADVISE ME ABOUT?
One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
The effectiveness of removal of any dermal filler has not been studied.
WHAT PRECAUTIONS SHOULD MY DOCTOR ADVISE ME ABOUT?
JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbolThe safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
WHAT ARE POSSIBLE SIDE EFFECTS OF TREATMENT?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThis product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGSDo not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
As with all transcutaneous procedures, injections of the product carry a risk of infection
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
This product should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients may experience late onset AEs with use of injectable gel implants, including this product
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® VOLUX® XC is an injectable gel designed to improve jawline definition in patients with moderate to severe loss of jawline definition. Adding volume to improve the shape and structure of the lower face helps provide smooth, long-lasting definition in the jawline for adults over 21 years of age.
JUVÉDERM® VOLUX® XC lasts up to 1 year, with optimal treatment.
Most side effects were mild or moderate in nature with duration of 14 days or less—35% of side effects lasted up to 30 days. The most common side effects were temporary reactions at the treatment site, such as tenderness, lumps/bumps, pain, swelling, firmness, bruising, redness, itching, and discoloration. As with all skin-injection procedures, there is a risk of infection.
JUVÉDERM® VOLUX® XC is a crystal-clear gel that is injected into the jaw to improve jawline definition. It temporarily adds volume to augment the shape and structure of the lower face and results in improved jawline definition in adults over the age of 21. The lidocaine in the gel improves the comfort of the injection by reducing sensitivity to pain.
IMPORTANT SAFETY INFORMATION
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
JUVÉDERM® Injectable Gel Fillers Important Information
ARE THERE ANY REASONS WHY I SHOULD NOT RECEIVE ANY JUVÉDERM® FORMULATION?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
WHAT WARNINGS SHOULD MY DOCTOR ADVISE ME ABOUT?
One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
The effectiveness of removal of any dermal filler has not been studied.
WHAT PRECAUTIONS SHOULD MY DOCTOR ADVISE ME ABOUT?
JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbolThe safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
WHAT ARE POSSIBLE SIDE EFFECTS OF TREATMENT?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThis product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGSDo not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
As with all transcutaneous procedures, injections of the product carry a risk of infection
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
This product should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients may experience late onset AEs with use of injectable gel implants, including this product
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® VOLLURE® XC is injected into the areas of facial tissue where moderate to severe facial wrinkles and folds, such as the parentheses lines or "smile/laugh lines" around the nose and mouth—also known as nasolabial folds—as well as deep lines that extend from the corners of the mouth to the chin—also known as marionette lines—occur.
Nasolabial folds are the deep lines and wrinkles that extend from the sides of the nose to the corners of the mouth.
JUVÉDERM® VOLLURE® XC is designed to temporarily correct facial wrinkles for a smoother appearance to the face for adults over the age of 21.The clinical study demonstrated JUVÉDERM® VOLLURE® XC lasts up to 18 months with optimal treatment.
The most common side effects included firmness, swelling, tenderness to touch, lumps/bumps, redness, pain, bruising, itching, and discoloration at the injection site. These side effects were usually mild or moderate in nature (causing little to some discomfort and impact on daily activities) and lasted 14 days or less.
Over time, wrinkles develop on your face, and nasolabial folds may become more visible. JUVÉDERM® VOLLURE® XC is designed to temporarily add volume to the facial wrinkles for a smoother appearance to the face. The lidocaine in the gel improves the comfort of the injection by reducing sensitivity to pain.
IMPORTANT SAFETY INFORMATION
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
JUVÉDERM® Injectable Gel Fillers Important Information
ARE THERE ANY REASONS WHY I SHOULD NOT RECEIVE ANY JUVÉDERM® FORMULATION?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
WHAT WARNINGS SHOULD MY DOCTOR ADVISE ME ABOUT?
One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
The effectiveness of removal of any dermal filler has not been studied.
WHAT PRECAUTIONS SHOULD MY DOCTOR ADVISE ME ABOUT?
JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbolThe safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
WHAT ARE POSSIBLE SIDE EFFECTS OF TREATMENT?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThis product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGSDo not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
As with all transcutaneous procedures, injections of the product carry a risk of infection
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
This product should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients may experience late onset AEs with use of injectable gel implants, including this product
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines (lines around the mouth), often called lipstick lines, vertical lip lines, or lip wrinkles in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC lasts up to 1 year, with optimal treatment.
The most common side effects included temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Side effects were mild or moderate (uncomfortable) and generally lasted 30 days or less.
JUVÉDERM® VOLBELLA® XC is a crystal-clear gel that is injected directly into and around the lips using an ultra-fine needle to temporarily plump the lips for lip augmentation and to smooth the appearance of lines around the mouth. The lidocaine gel improves the comfort of the injection by reducing sensitivity to pain.
IMPORTANT SAFETY INFORMATION
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
JUVÉDERM® Injectable Gel Fillers Important Information
ARE THERE ANY REASONS WHY I SHOULD NOT RECEIVE ANY JUVÉDERM® FORMULATION?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
WHAT WARNINGS SHOULD MY DOCTOR ADVISE ME ABOUT?
One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
The effectiveness of removal of any dermal filler has not been studied.
WHAT PRECAUTIONS SHOULD MY DOCTOR ADVISE ME ABOUT?
JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbolThe safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
WHAT ARE POSSIBLE SIDE EFFECTS OF TREATMENT?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThis product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGSDo not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
As with all transcutaneous procedures, injections of the product carry a risk of infection
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
This product should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients may experience late onset AEs with use of injectable gel implants, including this product
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
As you age, the cheeks may flatten and the skin may begin to sag. This is caused by natural loss of volume in the cheek area, or what the experts call age-related midface volume loss. JUVÉDERM® VOLUMA® XC adds volume beneath the skin's surface, which provides lift and contour to the cheek area.
JUVÉDERM® VOLUMA® XC provides natural-looking and long-lasting results that last up to 2 years with optimal treatment.
The most common side effects included temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching. Side effects were moderate (uncomfortable), and generally lasted 2 to 4 weeks. As with all skin injection procedures, there is a risk of infection.
As you age, the cheek area loses its youthful shape. The cheeks flatten out and the skin may begin to sag. JUVEDERM® VOLUMA® XC injectable gel is designed to temporarily reverse these signs of aging. It is a gel that is injected into the cheek area to lift the skin. It temporarily adds volume to the cheek area and results in a smoother contour and more youthful appearance to the face.
IMPORTANT SAFETY INFORMATION
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
JUVÉDERM® Injectable Gel Fillers Important Information
ARE THERE ANY REASONS WHY I SHOULD NOT RECEIVE ANY JUVÉDERM® FORMULATION?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
WHAT WARNINGS SHOULD MY DOCTOR ADVISE ME ABOUT?
One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
The effectiveness of removal of any dermal filler has not been studied.
WHAT PRECAUTIONS SHOULD MY DOCTOR ADVISE ME ABOUT?
JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbolThe safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
WHAT ARE POSSIBLE SIDE EFFECTS OF TREATMENT?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThis product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGSDo not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
As with all transcutaneous procedures, injections of the product carry a risk of infection
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
This product should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients may experience late onset AEs with use of injectable gel implants, including this product
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Ultra XC is an injectable gel that temporarily adds more fullness and plumps thin lips—whether your lips have thinned over time or you simply want fuller lips—in adults over the age of 21.
JUVÉDERM® Ultra XC lasts up to one year, with optimal treatment.
For lip augmentation, most side effects were mild or moderate in nature with duration of 14 days or less. The most common side effects were temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, and bruising.
JUVEDERM® Ultra XC is a crystal-clear gel that is injected directly into and around the lips using a small needle to temporarily add the desired range of fullness for lip enhancement in adults over the age of 21. The lidocaine in the gel improves the comfort of the injection by reducing sensitivity to pain.
IMPORTANT SAFETY INFORMATION
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
JUVÉDERM® Injectable Gel Fillers Important Information
ARE THERE ANY REASONS WHY I SHOULD NOT RECEIVE ANY JUVÉDERM® FORMULATION?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
WHAT WARNINGS SHOULD MY DOCTOR ADVISE ME ABOUT?
One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
The effectiveness of removal of any dermal filler has not been studied.
WHAT PRECAUTIONS SHOULD MY DOCTOR ADVISE ME ABOUT?
JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbolThe safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
WHAT ARE POSSIBLE SIDE EFFECTS OF TREATMENT?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThis product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGSDo not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
As with all transcutaneous procedures, injections of the product carry a risk of infection
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
This product should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients may experience late onset AEs with use of injectable gel implants, including this product
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
This product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGS
-
Do not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
-
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
-
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
-
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
-
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
-
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
-
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
-
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
-
As with all transcutaneous procedures, injections of the product carry a risk of infection
-
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
-
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
-
This product should be used with caution in patients on immunosuppressive therapy
-
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
-
Patients may experience late onset AEs with use of injectable gel implants, including this product
-
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
-
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call the Allergan® Product Support Department at 1-877-345-5372. Please see Directions for Use or visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
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As the first—and original—injectable collagen stimulator containing microparticles of poly-L-lactic acid (PLLA-SCA), Sculptra helps restore facial skin structure, which may provide long-lasting skin improvement.1-4
References:
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Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2023.
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Bergeret-Galley C. Comparison of resorbable soft tissue fillers. Aesthetic Surg J. 2004;24(1):33-46.
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Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915-922.
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Fitzgerald R, Bass LM, Goldberg DJ, Graivier MH, Lorenc ZP. Physiochemical characteristics of poly-L-lactic acid (PLLA). Aesthet Surg J. 2018;38(suppl 1):S13-S17.
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On average, you will have 2 to 3 treatment sessions over the course of a few months. The number of injections at each session will vary based on the treatment plan determined by you and your aesthetic professional.1
Reference:
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Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2023.
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Most clinical study participants saw results as soon as 1 month, with sustained results for up to 2 years. Work with your aesthetics professional on a treatment plan. Typical treatment is 3 sessions spaced at least 3 to 4 weeks apart.1-3
References:
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Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2023.
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Data on file. 43USSA1812EXT Clinical study report. Fort Worth, TX: Galderma Laboratories, L.P., 2022.
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Data on file. 43USSA1812 Clinical study report. Fort Worth, TX: Galderma Laboratories, L.P., 2022.
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Massage the treated area to evenly distribute Sculptra. A good rule of thumb is 5-5-5: Massage the injected area for 5 minutes, 5 times a day, for 5 days in a row.1
Reference:
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Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2023.
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Sculptra is used to correct shallow-to-deep wrinkles and folds on the face.1 Administered with the appropriate injection technique from a trained specialist, Sculptra is clinically approved for:
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Cheek wrinkles
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Deep folds between the nose and mouth (nasolabial folds), also called “smile lines”
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Lines framing the mouth (marionette lines)
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Chin wrinkles
For more specific product information about Sculptra, explore by treatment area on Discover Sculptra.
Reference:
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Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2023.
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If there are no complications, you may apply makeup several hours after treatment.1 Be sure to consult your doctor after treatment.
For further aftercare instructions, please visit our aftercare information.
Reference:
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Sculptra. Instructions for Use. Galderma Laboratories, L.P., 2023.
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Sculptra is FDA-approved in the United States and has been used worldwide since 1999. Sculptra is made of a synthetic material called poly-L-lactic acid that is absorbed naturally by the body and has been used for years in dissolvable stitches.
Since Sculptra does not contain any human or animal components, no allergy testing is needed prior to treatments.
Side effects reported include injection site pain, redness, bruising, tenderness, itching and lumps, bleeding, and swelling. Small bumps under the skin can sometimes be noticeable when pressing on the treated area. Larger lumps, with or without inflammation, have also been reported.
The types and duration of side effects may vary. If you are experiencing side effects, talk to your doctor. Please read our complete Important Safety Information.
Specialists who have been trained to inject Sculptra and are licensed to practice within the state may administer treatment. This can include physician assistants, nurse practitioners, registered nurses, and other trained personnel.
Galderma offers an extensive training program, because we believe that proper injection technique and aftercare are crucial to optimizing patient outcomes.
Training sessions are led by experienced Sculptra specialists around the country, offering a unique opportunity for dermatologists, plastic surgeons, and facial plastic surgeons to learn from their peers in a hands-on forum.
The training program undergoes continuous observation and refinement to help optimize patient outcomes.
We can help find a trained specialist near you.
There are several factors that figure into how much treatment will cost, including:
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Number of treatment sessions needed
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Number of Sculptra vials used per session
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Degree of necessary correction determined by you and your specialist
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Specialist fees
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Discounts and special offers
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Geographic market
Since injection costs will vary from person to person, the best way to determine projected costs is to consult your doctor. Average total treatment package costs can range from $800 to $3,500.
Comparing the cost of facial rejuvenation options can be challenging, because so much depends on desired results, the amount of product your doctor recommends, your response to treatment, and the amount of time results last.
A facial filler treatment that lasts 3 to 6 months may cost less up-front than one that lasts much longer, but it will generally require additional treatment sessions to maintain the effect for the same duration as one longer-lasting treatment. You may want to consider the total cost over time.
Coupon or rebate programs through Galderma and/or a specialist may be available from time to time. It’s a good idea to ask your specialist if there’s a discount program available at the time of consultation. We highly recommend joining ASPIRE Galderma Rewards, our loyalty program that rewards you with special points, offers, and rewards for every Galderma aesthetic treatment you receive—not just Sculptra.
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SAFETY AND SIDE EFFECTS
Sculptra is FDA approved in the U.S. and has been used worldwide since 1999.Sculptra contains a synthetic material called poly-L-lactic acid, which is biocompatible, biodegradable substance that is gradually and naturally absorbed by the body and commonly found in dissolvable stitches.
Though allergy testing is not required prior to treatment, you should not use Sculptra if you are allergic to any of its ingredients. You should also not use the product when you have an active skin infection or inflammation in the treatment area, or if you have a history or susceptibility to keloid formation or hypertrophic scarring.
The best way to minimize side effects is to seek a skilled specialist. Treatments should always be administered by a healthcare practitioner who has been thoroughly and specifically trained on Sculptra. Find a trained specialist near you.
In a clinical trial, the most commonly reported side effects after treatment were:
Redness
Swelling
Tenderness
Injection site pain
Bruising
Bleeding
Itching and lumps
Sculptra should be injected into the appropriate plane. Superficial injections may be associated with small bumps and larger lumps under the skin in the treated area. In a clinical study, a few subjects reported these bumps and lumps, but none of these events were reported as serious adverse events by the investigator.
Full Prescribing information
References:
Stein P, Vitavska O, Kind P, Hoppe W, Wieczorek H, Süchurer NY. The biological basis for poly-L-lactic acid-induced augmentation. J Dermatol Sci. 2015;78(1):26–33.
Goldberg D, Guana A, Volk A, Daro-Kaftan E. Single-arm study for the characterization of human tissue response to injectable poly-L-lactic acid. Dermatol Surg. 2013;39(6):915–922.
Shuster S, Black MM, McVitie E. The influence of age and sex on skin thickness, skin collagen and density. BR J Dermatol. 1975;93:639-643
Sculptra injectable poly-L-lactic acid. Instructions for Use. Galderma Laboratories. 2021.
Narins, Rhoda, Baumann, Lesie et. al. A Randomized Study of the Efficacy and Safety of Injectable Poly-L-lactic Acid Versus Human-Based Collagen implant in the treatment of nasolabial fold wrinkles
Oikarinen Aging of the Skin Connective Tissue: How To Measure The Biolchemical and mechanical properties of aging dermis. 1994: 10: 47-52 Department of Dermatology, University of Oulu, Finland.
Ganceviciene R, Liakou AI, Theodoridis A, Makrantonaki E, Zouboulis CC. Skin anti-aging strategies. Dermatoendocrinol. 2012;4(3):308–319.
Zhang S, Duan E. Fighting against Skin Aging: The Way from Bench to Bedside. Cell Transplant. 2018;27(5):729–738.
Wrinkle creams: Your guide to younger looking skin. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/wrinkles/in-depth/wrinkle-creams/art-20047463. Accessed January 17, 2020.
Vollmer DL, West VA, Lephart ED. Enhancing Skin Health: By Oral Administration of Natural Compounds and Minerals with Implications to the Dermal Microbiome. Int J Mol Sci. 2018;19(10):3059. Published 2018 Oct 7.
Can collagen supplements help tighten loose skin? Cleveland Clinic website. https://health.clevelandclinic.org/can-collagen-supplements-help-tighten-loose-skin/. Accessed January 17, 2020.
Botox injections. Mayo Clinic website. https://www.mayoclinic.org/tests-procedures/botox/about/pac-20384658. Accessed January 17, 2020.
Wrinkles. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/wrinkles/diagnosis-treatment/drc-20354931. Accessed December 3, 2019.
Injectable fillers guide. American Board of Cosmetic Surgery website. https://www.americanboardcosmeticsurgery.org/procedure-learning-center/non-surgical/injectable-fillers-guide/. Accessed January 17, 2020.
Gogolewski S, Jovanovic M, Perren SM, Dillon JG, Hughes MK. Tissue response and in vivo degradation of selected polyhydroxyacids: polylactides (PLA), poly(3-hydroxybutyrate) (PHB), and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHB/VA). J Biomed Mater Res. 1993;27(9):1135–1148.
Patient Brochure
Click here for patient information about Sculptra® (PDF)Important Safety Information
Indication: Sculptra® (injectable poly-L-lactic acid (PLLA-SCA)) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies, fine lines and wrinkles in the cheek region, and other facial wrinkles.
Sculptra should not be used by people that are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. Safety has not been established in patients who are pregnant, lactating, breastfeeding, or under 18 years of age.
Sculptra has unique injection requirements and should only be used by a trained healthcare practitioner. Contour deficiencies should not be overcorrected because they are expected to gradually improve after treatment.
Sculptra should not be injected into the blood vessels as it may cause vascular occlusion, infarction or embolic phenomena. Use at the site of skin sores, cysts, pimples, rashes, hives or infection should be postponed until healing is complete. Sculptra should not be injected into the red area (vermillion) of the lip or in the peri-orbital area.
The most common side effects after initial treatment include injection site swelling, tenderness, redness, pain, bruising, bleeding, itching and lumps. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported.
Sculptra is available only through a licensed practitioner. View the complete Instructions for Use.
KYBELLA® (deoxycholic acid) injection 10 mg/mL Important Information
INDICATION
KYBELLA® (deoxycholic acid) injection is indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults.
The safe and effective use of KYBELLA® for the treatment of subcutaneous fat outside the submental region has not been established and is not recommended.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
KYBELLA® is contraindicated in the presence of infection at the injection sites.
WARNINGS AND PRECAUTIONS
Marginal Mandibular Nerve Injury
Cases of marginal mandibular nerve injury, manifested as an asymmetric smile or facial muscle weakness, were reported in 4% of subjects in the clinical trials; all cases resolved spontaneously (range 1-298 days, median 44 days). KYBELLA® should not be injected into or in close proximity to the marginal mandibular branch of the facial nerve.
Dysphagia
Dysphagia occurred in 2% of subjects in the clinical trials in the setting of administration-site reactions, eg, pain, swelling, and induration of the submental area; all cases of dysphagia resolved spontaneously (range 1-81 days, median 3 days). Avoid use of KYBELLA® in patients with current or prior history of dysphagia as treatment may exacerbate the condition.
Injection-Site Hematoma/Bruising
In clinical trials, 72% of subjects treated with KYBELLA® experienced hematoma/bruising. KYBELLA® should be used with caution in patients with bleeding abnormalities or who are currently being treated with antiplatelet or anticoagulant therapy as excessive bleeding or bruising in the treatment area may occur.
Risk of Injecting Into or in Proximity to Vulnerable Anatomic Structures
To avoid the potential of tissue damage, KYBELLA® should not be injected into or in close proximity (1 cm-1.5 cm) to salivary glands, lymph nodes, and muscles. Care should be taken to avoid inadvertent injection directly into an artery or a vein as it can result in vascular injury.
Injection Site Alopecia
Cases of injection site alopecia have been reported with administration of KYBELLA®. Onset and duration may vary among individuals and may persist. Consider withholding subsequent treatments until resolution.
Injection Site Ulceration and Necrosis
Injections that are too superficial into the dermis may result in skin ulceration and necrosis. Cases of injection site ulceration, necrosis, and infection have been reported with administration of KYBELLA®. Do not administer KYBELLA® into affected area until complete resolution.
ADVERSE REACTIONS
The most commonly reported adverse reactions in the pivotal clinical trials were: injection site edema/swelling, hematoma/bruising, pain, numbness, erythema, and induration.
Please see KYBELLA® full Prescribing Information.
Schedule online anytime by engaging with the SKNCRAFT chat box located at the bottom right corner, simply type "schedule appointment" to get started or feel free to call or text 281-256-1003
JUVÉDERM® VOLBELLA® XC is an injectable gel that adds volume to improve the appearance of undereye hollowing. Undereye hollows are depressed, sunken, or hollow areas below the eyes that contribute to a tired-looking appearance.
JUVÉDERM® VOLBELLA® XC lasts up to 1 year in the undereye hollows with optimal treatment.
Most side effects were mild or moderate in nature and generally resolved within 30 days. The most common side effects were temporary reactions at the treatment site, such as tenderness, bruising, swelling, lumps/bumps, redness, pain, firmness, discoloration, or itching. As with all skin-injection procedures, there is a risk of infection.
JUVÉDERM® VOLBELLA® XC is a crystal-clear gel that is injected into the undereye area to improve the appearance of undereye hollows. It temporarily restores lost volume to the undereye hollows to create a smooth transition from the undereye area to the cheek area, with results that last up to 1 year with optimal treatment. The addition of lidocaine helps to improve the comfort of the injection by reducing sensitivity to pain.
IMPORTANT SAFETY INFORMATION
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
APPROVED USES
JUVÉDERM® VOLUX® XC injectable gel is for deep injection to improve moderate to severe loss of jawline definition in adults over the age of 21.JUVÉDERM® VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC, and JUVÉDERM® Ultra XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM® VOLLURE® XC injectable gel is for adults over 21.
JUVÉDERM® Ultra XC injectable gel is also for injection into the lips and perioral area for lip augmentation in adults over 21.
JUVÉDERM® VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and correction of perioral lines, and for injection into the undereye hollows to improve the appearance of undereye hollows in adults over the age of 21.
JUVÉDERM® Injectable Gel Fillers Important Information
ARE THERE ANY REASONS WHY I SHOULD NOT RECEIVE ANY JUVÉDERM® FORMULATION?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products, or if you have had previous allergic reactions to hyaluronic acid fillers.
WHAT WARNINGS SHOULD MY DOCTOR ADVISE ME ABOUT?
One of the risks with using dermal fillers is the unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, the complications can be serious and may be permanent. These complications, which have been reported for facial injections, can include vision abnormalities, blindness, stroke, temporary scabs, or permanent scarring of the skin. Most of these events are irreversible.If you have changes in your vision, signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion), white appearance of the skin, or unusual pain during or shortly after treatment, you should notify your health care practitioner immediately.
The use of dermal fillers where skin sores, pimples, rashes, hives, cysts, or infections are present should be postponed, as this may delay healing or make skin problems worse
The effectiveness of removal of any dermal filler has not been studied.
WHAT PRECAUTIONS SHOULD MY DOCTOR ADVISE ME ABOUT?
JUVÉDERM® VOLBELLA® XC should only be injected into undereye hollows by doctors who have completed the necessary training for this treatment area. To find a doctor, visit Juvederm.com/find-a-specialist. Doctors who complete the training will be listed with a symbolThe safety of these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA® XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of treatment with JUVÉDERM® products in anatomical regions outside of their approved uses have not been established in clinical studies
If you have a history of excessive scarring (thick, hard scars) or pigmentation disorders, treatment in these patients has not been studied and may result in additional scars or changes in pigmentation
If you are planning other procedures including laser treatments or a chemical peel, there is a possible risk of inflammation at the treatment site if these procedures are performed closely before or after JUVÉDERM® injectable gel treatment
Tell your doctor if you are on therapy used to reduce your body's natural defense system (such as steroids, chemotherapy, and medicines to treat autoimmune diseases, HIV, and AIDs), as these may increase your risk of infection; and medications that can prolong bleeding (such as aspirin, ibuprofen, or other blood thinners), as these may result in increased bruising or bleeding at the injection site.
Avoid applying makeup for 12 hours after treatment and minimize strenuous exercise, exposure to extensive sun or heat, and alcoholic beverages within the first 24 hours following treatment, as these may cause temporary redness, swelling, and/or itching at the injection site
JUVÉDERM® VOLUMA® XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients who experience skin injury near the site of JUVÉDERM® VOLUMA® XC injection may be at a higher risk for adverse events
Tell your doctor if you have already been injected with dermal fillers in the same area as the one(s) you are about to be treated for. This information helps your doctor decide when and whether you should get treatment
WHAT ARE POSSIBLE SIDE EFFECTS OF TREATMENT?
The most commonly reported side effects with JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported.These side effects are consistent with other facial injection procedures and most will resolve within 30 days. Your doctor may choose to treat side effects persisting longer with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any product in the JUVÉDERM® Collection, please call the Allergan® Product Support Department at 1-877-345-5372. Please also visit Juvederm.com or talk to your doctor for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
JUVÉDERM® Collection of Fillers Important Information
INDICATIONS
JUVÉDERM® VOLUMA® XC is indicated for deep (subcutaneous and/or supraperiosteal) injection for cheek augmentation to correct age-related volume deficit in the mid-face and for augmentation of the chin region to improve the chin profile in adults over the age of 21.
JUVÉDERM® VOLUX® XC injectable gel is indicated for subcutaneous and/or supraperiosteal injection for improvement of jawline definition in adults over the age of 21 with moderate to severe loss of jawline definition.
JUVÉDERM® VOLLURE® XC injectable gel is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over the age of 21.
JUVÉDERM® VOLBELLA® XC injectable gel is indicated for injection into the lips for lip augmentation and for correction of perioral rhytids, and for the improvement of infraorbital hollowing in adults over the age of 21.
JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC injectable gels are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
JUVÉDERM® Ultra XC injectable gel is indicated for injection into the lips and perioral area for lip augmentation in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThese products should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in these products.
WARNINGSDo not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
PRECAUTIONS
To minimize the risk of potential complications, these products should only be used by healthcare professionals with appropriate experience and training on facial anatomy and product use in indicated area(s), vasculature, safe injection techniques, and identification and management of potential adverse events, including intravascular complications
The potential risks of soft-tissue injections should be discussed with patients prior to treatment to ensure they are aware of signs and symptoms of complications
The safety and effectiveness for the treatment of anatomic regions other than indicated areas for each have not been established in controlled clinical studies
The safety for use of these products during pregnancy, in breastfeeding females, and in patients with known susceptibility to keloid formation, hypertrophic scarring, and pigmentation disorders has not been studied
The safety for use of JUVÉDERM® VOLUMA® XC has been established in patients between 35 and 65 years of age in cheek augmentation and for patients between 22 and 80 years of age for chin augmentation
The safety for use of JUVÉDERM® Ultra Plus XC and JUVÉDERM® Ultra XC in patients under 18 years, and JUVÉDERM® VOLUX® XC, JUVÉDERM® VOLLURE® XC and JUVÉDERM® VOLBELLA® XC in patients under 22 years, has not been established
As with all transcutaneous procedures, dermal filler implantation carries a risk of infection
Dermal fillers should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients who experience skin injury near the site of implantation may be at a higher risk for adverse events
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
The safety for use of JUVÉDERM® VOLUMA® XC injectable gel in patients with very thin skin in the mid-face has not been established
The safety of JUVÉDERM® VOLUMA® XC with cannula for cheek augmentation has not been established in patients with Fitzpatrick Skin Types V and VI
JUVÉDERM® VOLUMA® XC was not evaluated in subjects with significant skin laxity of the chin, neck, or jaw in the chin augmentation study
The effect of JUVÉDERM® VOLUMA® XC injection into the chin on facial hair growth has not been studied
Patients may experience late-onset adverse events with the use of dermal fillers, and late-onset nodules with use of JUVÉDERM® VOLUMA® XC
Based on preclinical studies, patients should be limited to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs) body mass per year. The safety of injecting greater amounts has not been established
Injection of more than 9 mL of JUVÉDERM® VOLUX® XC for improvement of jawline definition has not been studied
ADVERSE EVENTS
The most commonly reported side effects for JUVÉDERM® injectable gels were redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA® XC, dryness was also reported. The majority were mild or moderate in severity. For JUVÉDERM® VOLUMA® XC, most resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE® XC, JUVÉDERM® Ultra Plus XC , or JUVÉDERM® Ultra XC, most resolved within 14 days; and for JUVÉDERM® VOLBELLA® XC, most resolved within 30 days.
To report an adverse reaction with any product in the JUVÉDERM® Collection, please call Allergan® Product Support Department at 1-877-345-5372. Please visit JuvedermDFU.com for more information.
Products in the JUVÉDERM® Collection are available only by a licensed physician or properly licensed practitioner.
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-voluma-xc_dfu.pdf for JUVÉDERM® VOLUMA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volux-xc_dfu.pdf for JUVÉDERM® VOLUX® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-vollure-xc_dfu.pdf for JUVÉDERM® VOLLURE® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-volbella_dfu.pdf for JUVÉDERM® VOLBELLA® XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-plus- xc_dfu.pdf for JUVÉDERM® ULTRA PLUS XC
Please see Directions for Use or visit https://www.rxabbvie.com/pdf/juvederm-ultra-xc_dfu.pdf for JUVÉDERM® ULTRA XC
SKINVIVE™ by JUVÉDERM® Important Information
INDICATIONS
SKINVIVE™ by JUVÉDERM® injectable gel is indicated for intradermal injection to improve skin smoothness of the cheeks in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONSThis product should not be used in patients who have severe allergies, marked by a history of anaphylaxis or history or presence of multiple severe allergies, and should not be used in patients with a history of allergies to Gram-positive bacterial proteins or lidocaine contained in this product.
WARNINGSDo not inject into blood vessels. Introduction of this product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, after insertion of the needle and just before injection, the plunger rod can be withdrawn slightly to aspirate and verify the needle is not intravascular, inject the product slowly, and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Product use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled
Injection site responses consist mainly of short-term inflammatory symptoms and generally resolve within 1 week. Refer to the ADVERSE EVENTS
PRECAUTIONS
To minimize the risk of potential complications, this product should only be used by healthcare professionals who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection
Discuss all potential risks of soft tissue injections with patients prior to treatment and ensure patients are aware of signs and symptoms of potential complications
Limit patients to 20 mL of any JUVÉDERM® injectable gel per 60 kg (130 lbs.) body mass per year. The safety of injecting greater amounts has not been established
This product is intended for improving skin smoothness and fine lines of the cheeks. The safety and effectiveness of use in other areas of the body have not been established
Injection of more than 6.0 mL of this product (initial and touch-up treatment combined) for improvement of skin smoothness and fine lines of the cheeks has not been studied
As with all transcutaneous procedures, injections of the product carry a risk of infection
The safety for use during pregnancy, in breastfeeding females, and in patients under 22 years has not been established
The safety in patients with known susceptibility to keloid formation, hypertrophic scarring, or pigmentation disorders has not been studied
This product should be used with caution in patients on immunosuppressive therapy
Patients taking medications that can prolong bleeding (such as aspirin, nonsteroidal anti-inflammatory drugs, and warfarin) may experience increased bruising or bleeding at treatment sites
Patients may experience late onset AEs with use of injectable gel implants, including this product
This product should only be used by healthcare professionals who have appropriate experience and who are knowledgeable about the anatomy and the product for use in the face
If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or before skin has healed from a procedure prior to treatment, there is a possible risk of eliciting an inflammatory reaction at the injection site
ADVERSE EVENTS
In clinical studies, injection site responses (ISRs) observed in >5% of treated subjects included redness, lumps/bumps, swelling, bruising, pain, tenderness, firmness, discoloration, and itching. Most ISRs were mild. Adverse events reported through postmarketing surveillance outside of the United States included inflammatory reaction, inflammatory nodule, unsatisfactory result, loss/lack of correction, allergic reaction, anxiety, vascular occlusion, infection, dry skin, increase/decrease in sensation, and abscess.
To report an adverse reaction with SKINVIVE™ by JUVÉDERM®, please call Allergan® Product Support Department at 1-877-345-5372. Please visit SKINVIVEDFU.com for more information.
SKINVIVE™ by JUVÉDERM® is available only by a licensed physician or properly licensed practitioner.
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