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Frequently Asked Questions
Sculptra® is intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy)
in people with human immunodeficiency virus.
Sculptra® has been clinically proven to be an effective, well-tolerated, and long-lasting treatment
for the signs of facial lipoatrophy.
The following section is designed to help you learn more about Sculptra® and answer any questions
that your patients might have.
What is Sculptra®?
How does Sculptra® work?
Are skin tests required before treatment with Sculptra®?
Are the results from Sculptra® immediate?
How many treatments are required?
How long do treatment effects last?
How quickly can my patients return to their daily activities?
When will my patients be able to apply make-up after treatment?
What are the possible side effects of treatment with Sculptra®?
Who should not use Sculptra®?
What is Sculptra®?
Sculptra® is a synthetic injectable material known as "poly-L-lactic acid." Poly-L-lactic acid
is a biocompatible, biodegradable material that has been widely used for many years in
dissolvable stitches, soft tissue implants, and other types of
implants.
How does Sculptra® work?
Sculptra® is injected below the surface of the skin
in the area of fat loss. Sculptra® provides a gradual increase in skin thickness.
Visible results appear within the first few treatment
sessions.
Sculptra® will not correct the underlying cause of the facial fat loss, but will help
improve the appearance by increasing skin thickness in the treated
area.
Are skin tests required before treatment with Sculptra®?
No, skin testing is not required prior to use.
Are the results from Sculptra® immediate?
No. After the first treatment, it may appear that Sculptra® worked immediately. Typically,
patients will experience some degree of edema associated with the injection procedure, which
will give the appearance of a full correction by the end of the injection session (within
about 30 minutes). The patient should be informed that the injection-related edema typically
resolves in several hours to a few days, resulting in the "reappearance" of the original
contour deficiency. Sculptra® takes time to gradually correct the depression in the
skin.
How many treatments are required?
Each patient should be evaluated individually. More than one treatment session may be required.
Patients with severe facial fat loss may require 3 to 6 treatment sessions.
How long do treatment effects last?
Treatment effects will differ for each person. In a clinical study, the treatment results
lasted for up to 2 years after the first treatment session, in most patients. Touch-up
treatments may be needed to maintain the desired
effect.
How quickly can my patients return to their daily activities?
Most patients feel comfortable going back to their normal activities following
treatment.
When will my patients be able to apply make-up after treatment?
Make-up may be applied a few hours after treatment if no complications are
present (for example, open wounds or bleeding).
What are the possible side effects
of treatment with Sculptra®?
The most commonly observed product-related adverse event was the delayed occurrence of
subcutaneous papules (5 mm or less), which were typically palpable, asymptomatic, and
non-visible, and confined to the injection site area. Other reported side effects of
Sculptra® include immediate and transient injection-related events such as bleeding
from the injection site, discomfort, erythema or inflammation, ecchymosis, and
edema.
Advise patients to report any side effects to their
healthcare provider.
Who should not use Sculptra®?
Sculptra® is contraindicated in those individuals who have shown a hypersensitivity to any
of its components.
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