Sculptra.com: For Healthcare Professionals

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	How Sculptra® Works
	Volumetric Improvement
-	Safety and Tolerability
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	Product Information

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Sculptra® is clinically proven safe and well tolerated

Patients with treatment-related adverse events with 2-year follow-up¹

Injection Procedure- Related Adverse Events	VEGA Study (50 patients)	C&W Study* (29 patients)	Average Duration (days)
Bruising	3 (6%)	11 (38%)	6
Edema	2 (4%)	2 (7%)	3
Discomfort	0	3 (10%)	3
Hematoma	14 (28%)	0	17
Inflammation	0	3 (10%)	3
Erythema	0	3 (10%)	3
Device-Related Adverse Events			Average Onset† (months)
Injection-site subcutaneous papule (Lesions of 5 mm or less, typically palpable, asymptomatic, and non-visible)	26 (52%)	9 (31%)	7

*	Safety data were collected post hoc for 27 of the patients at approximately 2 years from study start.
†	Onset data available from VEGA study only. Duration not noted for subcutaneous papules because most were ongoing at study completion.

Patients with treatment-related adverse events with 1-year follow-up¹

Injection Procedure- Related Adverse Events	APEX 002 Study (99 patients)	Blue Pacific Study (99 patients)
Bruising	1 (1%)	30 (30%)
Edema	3 (3%)	17 (17%)
Discomfort	19 (19%)	15 (15%)
Erythema	0	3 (3%)
Device- Related Adverse Events
Injection-site subcutaneous papule (Lesions of 5 mm or less, typically palpable, asymptomatic, and non-visible)	6 (6%)	13 (13%)

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.

IMPORTANT SAFETY INFORMATION

Sculptra® is contraindicated in those individuals who have shown a hypersensitivity to any of its components. Sculptra® should not be injected in areas with active skin infection or inflammation. Avoid injection into the blood vessels.

The most commonly observed adverse event was the delayed occurrence of subcutaneous papules, which were confined to the injection site and were typically palpable, asymptomatic, and non-visible. Visible nodules, with or without inflammation or dyspigmentation, have also been reported. Other adverse events include immediate and transient injection-related events such as bleeding from the injection site, discomfort, erythema or inflammation, ecchymosis, and edema.

For more information, please see Full Product Information for Sculptra®