*January through November 2009.
†When compared to the nonlidocaine JUVÉDERM®
formulation.
‡Most subjects acquired optimal correction at initial
treatment. Some subjects required up to 2 touch-ups to achieve optimal
correction.
In the United States, JUVÉDERM® injectable gel is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
A Brief Description of Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events for JUVÉDERM® Injectable Gel
Indication: In the United States, JUVÉDERM® injectable gel (including JUVÉDERM® Ultra, JUVÉDERM® Ultra Plus, JUVÉDERM® Ultra XC, and JUVÉDERM® Ultra Plus XC) is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).
Contraindications: JUÉDERM® injectable gel should not be used in patients who have severe allergies marked by a history of anaphylaxis or history or presence of multiple severe allergies. JUVÉDERM® should not be used in patients with a history of allergies to Gram-positive bacterial proteins. JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC should not be used in patients with a history of allergies to lidocaine.
Warnings: JUVÉDERM® injectable gel should not be injected into blood vessels. If there is an active inflammatory process or infection at specific injection sites, treatment should be deferred until the underlying process is controlled.
Precautions: The safety of JUVÉDERM® for use during pregnancy, in breastfeeding females, or in patients under 18 years has not been established. The safety and effectiveness of JUVÉDERM® injectable gel for the treatment of areas other than facial wrinkles and folds (such as lips) have not been established in controlled clinical studies. Patients who are using substances that can prolong bleeding, such as aspirin or ibuprofen, as with any injection, may experience increased bruising or bleeding at injection site. Patients should inform their physician before treatment if they are using these types of substances. As with all skin-injection procedures, there is a risk of infection. JUVÉDERM® should be used with caution in patients on immunosuppressive therapy, or therapy used to decrease the body's immune response, as there may be an increased risk of infection. The safety of JUVÉDERM® in patients with a history of excessive scarring (eg, hypertrophic scarring and keloid formations) and pigmentation disorders has not been studied. If laser treatment, chemical peel, or any other procedure based on active dermal response is considered after treatment with JUVÉDERM® injectable gel, or if JUVÉDERM® is administered before the skin has healed completely after such a procedure, there is a possible risk of an inflammatory reaction at the treatment site.
Adverse events: The most commonly reported side effects are temporary injection-site redness, swelling, pain/tenderness, firmness, lumps/bumps, and bruising. Most side effects are mild or moderate in nature, and their duration is short lasting (7 days or less).
Important: For full safety information, please visit www.juvederm.com or call Allergan Product Support at 1-877-345-5372.
CAUTION: Rx only.
1. Data on file, Allergan,
Inc., November 2009; US Facial Injectables Market Share Report;
GuidePoint Global Filler Share Tracker.
2.
JUVÉDERM® Ultra XC Directions for Use.
3.
JUVÉDERM® Ultra Plus XC Directions for Use.
4.
Weinkle SH, Bank DE, Boyd CM, Gold MH, Thomas JA, Murphy DK. A
multi-center, double-blind, randomized controlled study of the safety
and effectiveness of JUVÉDERM® injectable gel with and
without lidocaine.
J Cosmet Dermatol. 2009;8(3):205-210.
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® and TM marks owned by Allergan, Inc. JUVÉDERM®
mark
owned by Allergan Industrie, SAS.