JUVEDERM VOLBELLA

APPROVED USES
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 JUVÉDERM VOLBELLA® XC injectable gel?
Do not use this product if you have a history of multiple severe allergies or severe allergic reactions (anaphylaxis), or if you are allergic to lidocaine or 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 JUVÉDERM VOLBELLA® XC for use during pregnancy or while breastfeeding has not been studied
• The safety of JUVÉDERM VOLBELLA® XC in patients under 22 years has not been studied
• The safety and effectiveness of JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in controlled clinical studies
• Tell your doctor if you have a history of excessive scarring (eg, hypertrophic scarring and keloid formation) or pigmentation disorders, as use of JUVÉDERM VOLBELLA® XC 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
• Tell your doctor if you are on immunosuppressive therapy used to decrease the body’s immune response, as use of JUVÉDERM VOLBELLA® XC 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 common side effects included swelling, tenderness, bruising, firmness, lumps/bumps, redness, pain, discoloration, itching, and dryness. Most side effects were mild or moderate and lasted 30 days or less.

One of the risks with using this product 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 JUVÉDERM VOLBELLA® XC, please call Allergan at 1-800-433-8871. Please also visit Juvederm.com for more information.

Available by prescription only.