JUVÉDERM® XC Important Information
JUVÉDERM® XC injectable gel is for injection into areas of facial tissue where moderate to severe facial wrinkles and folds occur to temporarily add volume to the skin, especially around the nose and mouth.
IMPORTANT SAFETY INFORMATION
Are there any reasons why I should not receive JUVÉDERM® XC?
Do not use the product if you have severe allergies with a history of severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or the proteins (gram-positive bacterial proteins) used to make the hyaluronic acid (HA) in JUVÉDERM® XC.
What precautions should my doctor advise me about?
- The safety of JUVÉDERM® 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 18 years has not been studied
- The safety and effectiveness for treatment in areas other than facial wrinkles and folds (such as lips) 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
- Tell your doctor 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 doctor 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
- If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment, or if the product is administered before the skin has healed completely, there is a possible risk of an inflammatory reaction at the treatment site
- As with all skin injection procedures there is a risk of infection
What are possible side effects?
The most commonly reported side effects for JUVÉDERM® XC injectable gel were temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, bruising, itching, and discoloration. They were predominantly mild or moderate in nature and lasted 7 days or less.To report a problem with JUVÉDERM® XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see the About Safety page at www.juvederm.com or call the Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM® XC injectable gel is available by prescription only.