Juvederm
JUVÉDERM XC non-surgical filler is approved for injection into the mid to deep dermis (below the outer layer of skin) for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases running from the bottom of your nose to the corners of your mouth, also known as parentheses or smile lines).
important safety information
Are there any reasons why I should not receive any JUVÉDERM® 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?
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 these products for use during pregnancy or while breastfeeding has not been studied
The safety of JUVÉDERM® VOLUMA™ XC has not been studied in patients under 35 years or over 65 years for cheek augmentation, or under 22 years and over 80 years for chin augmentation. The safety of JUVÉDERM® VOLLURE™ XC and JUVÉDERM® VOLBELLA™ XC has not been studied in patients under 22 years, and the safety of JUVÉDERM® XC and JUVÉDERM® Ultra XC has not been studied in patients under 18 years
The safety and effectiveness of JUVÉDERM VOLUMA® XC in areas other than the cheek area, JUVÉDERM® XC and JUVÉDERM VOLLURE™ XC for areas other than facial wrinkles and folds, and JUVÉDERM® Ultra XC and JUVÉDERM VOLBELLA® XC in areas other than the lips and perioral area have not been established in clinical studies
JUVÉDERM® VOLUMA™ XC is intended for use in the chin and cheek areas. JUVÉDERM® VOLLURE™ XC and JUVÉDERM® XC are intended for use in facial wrinkles and folds. JUVÉDERM® VOLBELLA™ XC and JUVÉDERM® Ultra XC are intended for use in the lips and perioral area. The safety and effectiveness for treatment in other areas have not been established in clinical studies
Tell your doctor if you have a history of excessive scarring (thick, hard scars) or pigmentation disorders. The safety of JUVÉDERM® products has not been studied in these patients 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 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 injection may be at a higher risk for adverse events
JUVÉDERM® VOLUMA™ XC was not studied in patients with significant loose skin of the chin, neck, or jaw
The effect of JUVÉDERM® VOLUMA™ XC injection into the chin on facial hair growth has not been studied
What are possible side effects?
The most commonly reported side effects with JUVÉDERM® injectable gels included redness, swelling, pain, tenderness, firmness, lumps/bumps, bruising, discoloration, and itching. For JUVÉDERM® VOLBELLA™ XC, dryness was also reported. For JUVÉDERM® VOLUMA™ XC, most side effects resolved within 2 to 4 weeks. For JUVÉDERM® VOLLURE™ XC, JUVÉDERM® XC, and JUVÉDERM® Ultra XC injectable gels, most resolved within 14 days or less. For JUVÉDERM® VOLBELLA™ XC, most resolved within 30 days or less. These side effects are consistent with other facial injection procedures.
Most side effects will resolve with time. Your doctor may choose to treat side effects persisting over 30 days with antibiotics, steroids, or hyaluronidase (an enzyme that breaks down hyaluronic acid).
One of the risks with these products is unintentional injection into a blood vessel. The chances of this happening are very small, but if it does happen, 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 of the skin.
As with all skin injection procedures, there is a risk of infection.
APPROVED USES
JUVÉDERM VOLUMA XC injectable gel is for deep injection in the cheek area to correct age-related volume loss and for augmentation of the chin region to improve the chin profile in adults over 21.
JUVÉDERM VOLLURE XC and JUVÉDERM XC injectable gels are for injection into the facial tissue for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. JUVÉDERM VOLLURE XC injectable gel is for adults over 21.
JUVÉDERM VOLBELLA XC injectable gel is for injection into the lips for lip augmentation and for correction of perioral lines in adults over 21.
JUVÉDERM Ultra XC injectable gel is for injection into the lips and perioral area for lip augmentation in adults over 21.
How long does JUVÉDERM VOLUMA XC last?
JUVÉDERM VOLUMA XC provides results that can last up to 1 year in the chin with optimal treatmen
What are the potential side effects of JUVÉDERM VOLUMA XC?
For chin augmentation, the most common side effects were temporary reactions at the treatment site, such as tenderness, firmness, swelling, pain, lumps/bumps, redness, itching and discoloration. Most of the side effects were mild in nature, and generally resolved in 2-4 weeks. As with all skin-injection procedures, there is a risk of infection.
How does JUVÉDERM VOLUMA XC work?
JUVÉDERM® VOLUMA™ XC is injected into the chin area to increase chin projection. It temporarily adds volume to the chin area and results in an improved chin shape. The addition of lidocaine helps to improve the comfort of the injection by reducing sensitivity to pain.
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