Consumer Information

Sculptra

Generic name: injectable poly-L-lactic acid
Date of Approval: August 3, 2004
Company: Dermik Laboratories
Sculptra is a treatment for: Facial Lipoatrophy (wasting) in HIV Patients

FDA approves Sculptra

Feedback for Sculptra

User Comments	Avg User Rating
0 Comments	Be the first to rate it

The U.S. Food & Drug Administration (FDA) has approved Sculptra (injectable poly-L-lactic acid) as the only product for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Sculptra is an injectable implant that contains microparticles of poly-L-lactic acid, a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra is reconstituted prior to use by the addition of sterile water for injection.

Facial lipoatrophy is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes. Lipoatrophy is common among HIV patients.

What is Sculptra?

Sculptra is a safe, synthetic, and biocompatible material that is injected below the surface of the skin in the area of fat loss. Sculptra provides a gradual and significant increase in skin thickness, improving the appearance of folds and sunken areas. For most people who participated in a clinical study, the treatment results lasted for up to two years after the first treatment session.

More than 150,000 people in over 30 countries worldwide have been treated with Sculptra, under the trade name New-Fill, for a variety of facial volume and contour deficiencies. It was approved in Europe in 1999 to increase the volume of depressed areas, particularly for the correction of skin depression, including skin creases, wrinkles, folds, scars, and eye rings. In 2004, the product was approved in Europe for large-volume corrections of the signs of lipoatrophy.

Because the main component in Sculptra, poly-L-lactic acid, is a polymer synthetically derived from natural components and is a biocompatible substance, there is no need to test for allergic reactions. Poly-lactic acid has been used in surgical products for more than 20 years as a component of dissolvable sutures and is used as a vehicle for several sustained-release injectable medications.

Sculptra should not be used by those who are allergic to any ingredient of Sculptra. Sculptra should not be injected while there is an infection or inflammation in the treatment area.

Sculptra side effects

Side effects of Sculptra may include the delayed appearance of small bumps under the skin in the treated area. Generally these bumps are not visible and may only be noticed when pressing on the treated area. Other Sculptra side effects may include injection-related events at the site of injection, such as bleeding, tenderness or discomfort, redness, bruising, or swelling.

Commercial availability of Sculptra is expected in the third quarter of this year.

For more information, please visit www.sculptra.com.