Juvederm Safety Information

JUVÉDERM® Injectable Gel Fillers Important Information
APPROVED USES

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.

IMPORTANT SAFETY 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

  • 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

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 symbol

  • The 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® 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

  • 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

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 with time. Your doctor may choose to treat side effects persisting over 30 days 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.