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.
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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.
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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