JUVÉDERM
Important Safety Information

JUVÉDERM Ultra and JUVÉDERM Ultra Plus injectable gel are indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds). Side effects were usually mild to moderate, lasting 7 days or less, and included temporary injection-site reactions such as redness, pain, firmness, swelling, and bumps. JUVÉDERM is not for people with severe allergies. For more information, please click on the About Safety link at www.juvederm.com or call the Allergan Product Support line at 1-877-345-5372. JUVÉDERM injectable gel is available by prescription only.

Please see additional Important Safety Information about JUVÉDERM injectable gel below.

BOTOX Cosmetic
Additional Important Safety Information

The FDA on April 30, 2009, in its update to the early communication sent in 2008, gave the following recommendations:

Understand that dosage strength (potency) expressed in “Units” or “U” are different among the botulinum toxin products; clinical doses expressed in units are not interchangeable from one botulinum toxin product to another.

Be alert to and educate patients and caregivers about potential adverse events due to distant spread of botulinum toxin effects following local injections including: unexpected loss of strength or muscle weakness, hoarseness or trouble talking (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids.

Understand that these adverse events have been reported as early as several hours and as late as several weeks after treatment.

BOTOX Cosmetic is a pharmaceutical drug administered by physicians and is available only by prescription.

A Brief Description of Relevant Indications for Use, Contraindications, Warnings, Precautions, and Adverse Events for JUVÉDERM Injectable Gel

Indication: In the United States, JUVÉDERM injectable gel is indicated for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

Contraindications: JUVÉDERM 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 injectable gel should not be used in patients with a history of allergies to Gram-positive bacterial proteins.

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 injectable gel 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 injectable gel 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 injectable gel 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 injectable gel 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.

[top]