JUVÉDERM® XC is an injectable filler (injectable facial filler), is used by cosmetic, dermatological, and plastic surgeons to soften deep folds and reduce wrinkles in the faces of patients. The substance is largely hyaluronic acid, a substance normally found in the skin, muscles, and tendons of mammals. Approved in June 2006 by the U.S. Food and Drug Administration, Juvéderm’s prime use is removing nasolabial folds, or “smile lines,” creases of skin which run from the corners of the nose to the corners of the mouth. It is also used as a lip augmentation agent, and to fill in hollow places and scars on the face. However, all hyaluronic acid facial filler products are eventually absorbed by the body, usually within six to nine months, causing the patient to undergo repeat injections to maintain the younger look. Juvéderm is also used by physicians to plump lips, which also lose fat and internal shape with normal aging.
JUVÉDERM® XC injectable gel is for injection into areas of facial tissue where moderate to severe facial wrinkles and folds occur to temporarily add volume to the skin, especially around the nose and mouth.
JUVÉDERM VOLUMA® XC injectable gel is for deep injection in the 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® 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.
For JUVÉDERM VOLUMA® XC, side effects are moderate (uncomfortable), and generally last 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.
As with all skin-injection procedures, there is a risk of infection.
To report a side effect with JUVÉDERM® XC or JUVÉDERM VOLUMA® XC, please call Allergan Product Surveillance at 1-800-624-4261.
For more information, please see the Frequently Asked Questions page at www.juvederm.com or call the Allergan Medical Information line at 1-800-433-8871.
JUVÉDERM® XC and JUVÉDERM VOLUMA® XC injectable gels are available by prescription only.