JUVÉDERM VOLUMA® XC is the first and only FDA-approved injectable gel to instantly add volume to your 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 VOLUMATM XC injectable gel?

Your doctor will ask about your medical history to determine if you are an appropriate candidate for treatment.
You should not use the product if you have severe allergies with a history of severe reactions (anaphylaxis). Use may result in an allergic reaction.
•You should not use the product if you are allergic to lidocaine or to the proteins used to make the HA in JUVÉDERM VOLUMATM XC (gram-positive bacterial proteins). Use may result in an allergic reaction.

What precautions should my doctor advise me about?

The following are important treatment considerations for you to discuss with your doctor and understand in order to help avoid unsatisfactory results and complications.

• Minimize strenuous exercise and exposure to extensive sun or heat within the first 24 hours following treatment. Exposure to any of these may cause temporary redness, swelling, and/or itching at the injection site.
• Tell your doctor if you are pregnant or breastfeeding. The safety of JUVÉDERM VOLUMATM XC injectable gel for use during pregnancy, or in women who are breastfeeding, has not been studied.
• Tell your doctor your age and discuss how your age may influence your decision to use this product. The safety of JUVÉDERM VOLUMATM XC has not been studied in patients under 35 years or over 65 years.
• Tell your doctor which areas of your face you would like to have treated. This product is intended for use in the cheek area, as shown in the highlighted regions in Figure 1, found in Section 3. The safety and effectiveness for treatment in other areas have not been established in controlled, clinical studies.
• Tell your doctor if you have a history of excessive scarring (thick, hard scars). The safety of JUVÉDERM VOLUMATM XC injectable gel in patients with a history of excessive scarring has not been studied and may result in additional scars.
• Tell your doctor if you have a history of pigmentation disorders. The safety of JUVÉDERM VOLUMATM XC in patients with a history of pigmentation disorders has not been studied. Use in these patients may result in 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 before treatment if you are using substances 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.
• Patients who experience skin injury near the site of JUVÉDERM VOLUMATM XC implantation may be at a higher risk for adverse events.

What are possible side effects?

In the clinical study, most side effects were moderate (uncomfortable) in nature, and generally lasted 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. These side effects are consistent with other facial-injection procedures.

Although most side effects will resolve with time, some side effects may persist longer than 30 days. Your doctor may choose to treat them with medications, such as antibiotics, steroids, or hyaluronidase (an enzyme that breaks down HA).
As with all skin-injection procedures, there is a risk of infection.