JUVÉDERM®

What is JUVÉDERM®, JUVÉDERM® Ultra and JUVÉDERM® Ultra Plus?

JUVÉDERM® Ultra and JUVÉDERM® Ultra Plus, approved by the FDA in June 2006, are hyaluronic acid (HA) dermal fillers and the only HA dermal fillers FDA-approved to last one year from initial treatment (includes up to two touch ups), providing a smooth, long-lasting correction of moderate to severe facial wrinkles and folds. JUVÉDERM® dermal filler is the latest advance in HA dermal filler options from Allergan, Inc. 

• JUVÉDERM® is the first and only smooth consistency gel formulation, and the only HA dermal filler developed using the proprietary HYLACROSS™ technology, a technologically advanced manufacturing process that results in a malleable, smooth gel. JUVÉDERM® flows easily into the skin and creates a smooth, natural look and feel.
• All other HA dermal fillers currently on the market have a granular consistency gel. These granules can be seen under 2.4X magnification as opposed to the smooth consistency gel of JUVÉDERM® dermal filler.
• In addition, JUVÉDERM® contains a high concentration of non-animal, cross-linked HA. This unique attribute provides optimal results with a single treatment in the majority of patients and delivers sustained results for up to one year.
• JUVÉDERM® dermal filler is biodegradable and has demonstrated its safety and effectiveness in patients of color. Studies with JUVÉDERM® demonstrated no increased risk of hyperpigmentation or hypertrophic scarring in patients of color.
• JUVÉDERM® Ultra and JUVÉDERM® Ultra Plus can be administered in a smooth-flowing injection, providing physicians with a high level of control for individualized, tailored wrinkle treatment and for achieving a smooth and natural look.
• The U.S. Food and Drug Administration (FDA) approved the following formulations of JUVÉDERM®, providing physicians with the flexibility to tailor each treatment to the particular needs of the patient. Product formulations include:
• JUVÉDERM® Ultra, a highly cross-linked formulation for more versatility in contouring and volumizing of facial wrinkles and folds
• JUVÉDERM® Ultra Plus, a more highly cross-linked robust formulation for volumizing and correction of deeper folds and wrinkles

How JUVÉDERM® Works

• The key component in JUVÉDERM®, hyaluronic acid, is a naturally occurring, biodegradable complex sugar found in the human body and in all mammals. Among other things, hyaluronic acid hydrates the skin and adds volume, contributing to the overall appearance of the skin.
• The ability of cells to produce hyaluronic acid diminishes with age, often resulting in the formation of facial wrinkles and folds as the skin loses volume. JUVÉDERM® is administered in small doses by intradermal injection directly into moderate to severe facial wrinkles and folds, such as nasolabial folds (the “parentheses” along the side of the nose and mouth), temporarily filling and augmenting the treated area.
• JUVÉDERM® Ultra and JUVÉDERM® Ultra Plus should only be administered by a trained and qualified health care provider. Further product and patient risk information is available by consulting with Dr. Mishra at Ajuva Cosmetique at Eye Associates of Pinellas.

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 (e.g., 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).

CAUTION: This device is restricted to sale by or on the order of a physician.