SCULPTRA® (sanofi-aventis) 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, USP (SWFI) to form a sterile non-pyrogenic suspension.
INTENDED USE / INDICATIONS
SCULPTRA is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus.
CONTRAINDICATIONS
• SCULPTRA should not be used in any person who has hypersensitivity to any of the components of the product.
WARNINGS
• Use of SCULPTRA in any person with active skin inflammation or infection in or near the treatment area should be deferred until the inflammatory or infectious process has been controlled.
• Do not overcorrect (overfill) a contour deficiency because the depression should gradually improve within several weeks as the treatment effect of SCULPTRA occurs (see PATIENT TREATMENT).
• Injection procedure reactions to SCULPTRA have been observed consisting mainly of hematoma, bruising, edema, discomfort, inflammation, and erythema. The most common device related adverse effect was the delayed occurrence of subcutaneous papules, which were confined to the injection site and were typically palpable, asymptomatic and non-visible. Refer to ADVERSE EVENTS for details.