JUVÉDERM

IMPORTANT SAFETY INFORMATION

Are there any reasons why I should not receive JUVÉDERM® XC or JUVÉDERM VOLUMA® XC?

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 the proteins (gram-positive bacterial proteins) used to make the hyaluronic acid (HA) in these products. Do not use JUVÉDERM® XC or JUVÉDERM VOLUMA® XC if you are allergic to lidocaine.

What precautions should my doctor advise me about?

• The safety of JUVÉDERM® XC and JUVÉDERM VOLUMA® XC injectable gels for use during pregnancy or in women who are breastfeeding has not been studied
• The safety of JUVÉDERM® XC for use in patients under 18 years and JUVÉDERM VOLUMA® XC for patients under 35 years or over 65 years has not been studied
• The safety and effectiveness of JUVÉDERM® XC for treatment of areas other than facial wrinkles and folds (such as lips) have not been established in clinical studies
• The safety and effectiveness of JUVÉDERM VOLUMA® XC for treatment in areas other than the cheek area have not been established in clinical studies
• The safety of JUVÉDERM® XC and JUVÉDERM VOLUMA® XC in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied, and use may result in additional scars or changes in pigmentation
• The safety of JUVÉDERM VOLUMA® XC in patients with very thin skin in the cheek area and the safety of repeat treatments in patients has not been studied
• There is a possible risk of inflammation at the treatment site if laser procedures and chemical peeling are performed after treatment
• Patients who experience skin injury near the site of injection with these products may be at a higher risk for side effects
• Tell your health care professional if you are on therapy used to decrease the body’s immune response (immunosuppressive therapy). Use of these products may result in an increased risk of infection
• Tell your health care professional 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 and exposure to extensive sun or heat within the first 24 hours following treatment with JUVÉDERM VOLUMA® XC

What are possible side effects?

For JUVÉDERM® XC, most side effects are mild or moderate in nature, and last 7 days or less. The most common side effects include temporary injection-site reactions such as: redness, pain/tenderness, firmness, swelling, lumps/bumps, bruising, itching, and discoloration.