JUVÉDERM VOLUMA® XC IMPORTANT INFORMATION
JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over the age of 21.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM VOLUMA® XC?
Do not use if you have a history of severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to the proteins (grampositive bacterial proteins) used to make the hyaluronic acid (HA) in JUVÉDERM VOLUMA® XC.
What precautions should my healthcare professional advise me about?
- The safety of JUVÉDERM VOLUMA® XC injectable gel for use during pregnancy, in women who are breastfeeding, or in patients with very thin skin in the cheek area has not been studied
- The safety for use in patients under 35 years or over 65 years has not been studied
- The safety and effectiveness for treatment in areas other than the cheek area have not been established
- The safety for use in patients with a history of excessive scarring or pigmentation disorders has not been studied and may result in additional scars or changes in pigmentation
- The long-term safety of repeat treatments has not been established
- Patients who experience skin injury near the site of injection may be at a higher risk for side effects
- Tell your healthcare professional if you are on therapy used to decrease the body’s immune response (immunosuppressive therapy). Use may result in an increased risk of infection
- Tell your healthcare professional if you are using medications that can prolong bleeding, such as aspirin, ibuprofen, or other blood thinners; as with any injection, this may result in increased bruising or bleeding at the injection site
- Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment
What are possible side effects?
Side effects are moderate (uncomfortable) and generally last 2 to 4 weeks. The most common side effects include temporary reactions at the treatment site such as tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.
To report a side effect, please call Allergan Product Surveillance at 1-877-345-5372.
For more information, please see www.juvederm.com or call the Allergan Medical Information line at 1-800-766-0171.
JUVÉDERM VOLUMA® XC injectable gel is available by prescription only.