sanofi-aventis
FOR US RESIDENTS ONLY
Sculptra<sup>®</sup> (injectable poly-L-lactic acid)
Sculptra® Cosmetic is intended for volume restoration and/or correction of moderate to deep facial wrinkles and folds such as nasolabial lines or folds.

IMPORTANT SAFETY INFORMATION
Side effects of Sculptra® Cosmetic may include injection site discomfort, redness, bruising, bleeding, or swelling. Other side effects may include small bumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, with or without inflammation, have also been reported. In clinical studies the numbers of bumps and lumps was low and most resolved without treatment.

Sculptra® is injected into the skin for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

In a clinical study, the effects lasted for up to 2 years after the first treatment session in most patients. The results from Sculptra® are not immediate; Sculptra® provides a gradual increase in skin thickness. Your doctor will determine the number of additional injections needed.

Sculptra® is a safe, synthetic, and biocompatible material that is injected below the surface of the skin in the area of fat loss. It provides a gradual and significant increase in skin thickness, improving the appearance of folds and sunken areas. No skin testing is required.

To learn more about treatment with Sculptra®, please talk to your doctor.

Sculptra® is injected into the skin for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.

Areas of the Face Treated with Sculptra® in Clinical Studies
IMPORTANT SAFETY INFORMATION
You should not use Sculptra® if you are allergic to any ingredient of the product or have a history of keloid formation or hypertrophic scarring. It should not be injected while you have an active skin infection or inflammation in the treatment area and should not be injected into the red area of the lip. Use in the skin near the eyes is not recommended.

Side effects may include injection site discomfort, redness, bruising, bleeding, itching and swelling. Other side effects may include small lumps under the skin that are sometimes noticeable when pressing on the treated area. Larger lumps, some with delayed onset with or without inflammation or skin discoloration, have also been reported. In the clinical studies the numbers of small and larger lumps were low and most resolved without treatment.

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US.POL.10.06.004 Last Update: August 2010