VOLUMA® XC Important Information

APPROVED USES

JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the cheek area to correct age-related volume loss in adults over 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 has not been studied

The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek 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 these products 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 common side effects include tenderness, swelling, firmness, lumps/bumps, bruising, pain, redness, discoloration, and itching.For JUVÉDERM VOLUMA® XC, side effects are moderate (uncomfortable) and last 2 to 4 weeks.

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.