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INDICATIONS: Sculptra Aesthetic (poly-L-lactic acid) is indicated for use in people with healthy immune systems for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which the deep dermis layer is treated. Sculptra Aesthetic is also indicated for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
CONTRAINDICATIONS: Sculptra Aesthetic should not be used by people with known hypersensitivity to any of the components of the product. Do not use in patients with active skin inflammation or infection. Do not inject into blood vessels, lip mucosa, or periorbital area.
WARNINGS AND PRECAUTIONS: Sculptra Aesthetic should only be used by licensed healthcare practitioners. Have the patient inform their healthcare practitioner if they are taking blood-thinning medications prior to treatment. The use of Sculptra Aesthetic may result in visible skin nodules, which may or may not be noticeable and may be permanent. Injection site reactions may occur. Patients with history of keloid formation or hypertrophic scarring may be at higher risk.
MOST COMMON ADVERSE EVENTS: The most common adverse events reported in controlled clinical studies included injection site bruising, erythema, pain, and swelling. Subcutaneous papules and nodules have been reported. Most side effects resolved on their own within a few days to a few weeks. As with any injectable, there is a risk of infection.