JUVÉDERM® INJECTABLE GEL FILLERS INDICATIONS AND IMPORTANT SAFETY INFORMATION
JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 21. JUVÉDERM VOLLURE™ XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in adults over 21. JUVÉDERM® XC injectable gel is for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). JUVÉDERM® Ultra XC is for injection into the lips and perioral area for lip augmentation in adults over the age of 21. JUVÉDERM VOLBELLA® XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive any JUVÉDERM® injectable gel formulation?
Do not use these products if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the Gram-positive bacterial proteins used in these products.
What precautions should my doctor advise me about?
· Tell your doctor if you are pregnant or breastfeeding. The safety of these products for use during pregnancy or while breastfeeding has not been studied
· The safety of JUVÉDERM VOLUMA® XC in patients under 35 years or over 65 years, the safety of JUVÉDERM® XC and JUVÉDERM®Ultra XC injectable gels in patients under 18 years, and the safety of JUVÉDERM VOLLURE™ XC and JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied
· The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in clinical studies
· Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formations) or pigmentation disorders, as use of these products may result in additional scars or changes in pigmentation
· Tell your doctor if you are planning other laser treatments or a chemical peel, as there is a possible risk of inflammation at the treatment site if these procedures are performed after treatment
· Patients who experience skin injury near the site of injection with this product may be at a higher risk for side effects
· Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of these products may result in an increased risk of infection
· Tell your doctor if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners, as this 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
What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included injection-site redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM VOLBELLA® XC, dryness was also reported. For JUVÉDERM VOLUMA® XC, most side effects were moderate and lasted 2 to 4 weeks. For JUVÉDERM® XC, JUVÉDERM VOLLURE™ XC, and JUVÉDERM® Ultra XC injectable gels, most side effects were mild or moderate and lasted 14 days or less. For JUVÉDERM VOLBELLA®XC, most side effects were mild or moderate and lasted 30 days or less.
One of the risks with using these products is unintentional injection into a blood vessel, and while rare, 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.
As with all skin injection procedures, there is a risk of infection.
To report a side effect with any JUVÉDERM® product, please call Allergan at 1-800-433-8871. Please visit Juvederm.com or talk to your doctor for more information.
Available by prescription only.