Generic name: injectable poly-L-lactic acid (PLLA)
Date of Approval: August 3, 2004
Treatment for: Facial Lipoatrophy (wasting) in HIV Patients
What is Sculptra?
The U.S. Food & Drug Administration (FDA) approved Sculptra (injectable poly-L-lactic acid) for the restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus (HIV). Facial lipoatrophy is the loss of fat beneath the skin, which can result in sunken cheeks, indentations, and hollow eyes. Lipoatrophy is common among HIV patients.
Sculptra is a synthetic and biocompatible material that is injected below the surface of the skin in the area of fat loss. Sculptra contains microparticle beads of poly-L-lactic acid, a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra provides a gradual and significant increase in skin thickness, improving the appearance of folds and sunken areas.
Visible results appear in the first few treatment sessions. Typically, 3 to 6 sessions are conducted and additional touch-up treatment may be needed. Over time, the beads break down and may be replaced with natural collagen. For most people who participated in a clinical study, the treatment results lasted for up to two years after the first treatment session. Assessments will be done 2 weeks or more after treatment to determine if additional injections are required.
Sculptra should not be used by those who are allergic to any ingredient of Sculptra. Sculptra should not be injected while there is an infection or inflammation in the treatment area.
Sculptra Clinical Trials
Four studies evaluated Sculptra in 278 patients with HIV-associated severe facial lipoatrophy. An increase in skin thickness from baseline was seen starting from week 8 to 12, at an average range of 3.9 to 5.3 mm in the cheek and nasolabial areas.
Important Safety Information
Sculptra should not be used by those who are allergic to any ingredient of Sculptra, including poly-L-lactic acid, carboxymethylcellulose, and nonpyrogenic mannitol.
Sculptra should not be injected while there is an infection or inflammation in the treatment area. Sculptra should not be used if a patient has had or has risks for hypertrophic scarring or keloid formation. Tell your provider if you have an active skin infection or inflammation (i.e., cysts, pimples, rash or hives), or problems with hearing located close to the treatment site.
Patients who have coagulation defects or are using blood thinners or anticoagulants such as aspirin, warfarin, or Plavix may be at a greater risk of hematoma formation, bleeding or bruising at the injection site. NSAIDs may also increase the risk for bleeding/bruising.
Skin testing is not required prior to using Sculptra.
Studies of Sculptra for longer than 2 years has not been done. Also, safety and effectiveness in pregnancy or breast-feeding has not been done. Use of Sculptra in patients less than 18 years of age is not recommended.
Studies of the use of Sculptra with lidocaine for local anesthesia, or with other drugs or implants has not been completed. However, your healthcare provider may recommend the use of lidocaine for anesthesia.
There have been reports of an increased risk of papules and nodules after injecting Sculptra around the eye (periorbital) area.
After Sculptra treatment, avoid sun and UV lamp exposure until initial redness and swelling has subsided.
Chemical peels, laser treatment, or any other active dermal treatment given before or after Sculptra treatment may result in an increased inflammatory response at the Sculptra implant site, especially if the area of active dermal treatment has not healed.
Sculptra should not be injected into the red area of the eyes or of the lips.
If facial radiologic imaging, such as computed tomography (CT) scan or magnetic resonance imaging (MRI), is to take place, notify your physician in advance that you have had Sculptra treatments.
Sculptra Side Effects
The most common side effects with Sculptra include injection site reactions, such as bruising (21%), pain (13%), swelling (10%), and redness (2%). Itching and heat sensation have also been reported. Injection site reactions tend to last 3 to 17 days, on average. Treatment, if needed for injection reactions, may include antihistamines or anti-inflammatories.
Small lumps (granulomas) under the skin, which may or may not be visible, may occur within the first 6 to 12 months after treatment. The bumps may or may not be permanent. Visible bumps may be red in the treated area. Some lumps have had to be treated with corticosteroid injections or surgery. The risk of infection and serious swelling is a possibility, as well.
Other post-marketing side effects have been spontaneously reported after Sculptra use. If you have a concern, ask your healthcare provider for more information about post-marketing side effects.
What to Expect During and After the Treatment Visit?
You and your physician will determine if local anesthesia is required prior to injection. Tell your healthcare provider about all medications you take, including prescription, over-the-counter, herbal, and dietary supplements.
Remove all makeup prior to injections. The area to be injected will be cleaned with an antiseptic. Multiple injections using a fine needle will be required. After injection the area will be massaged to evenly distribute the product. Apply an ice pack to reduce swelling unless otherwise directed.
Some redness and swelling after injections are to be expected. Your healthcare provider will give you specific directions on how to minimize this effect. Report any unusual signs or symptoms to your doctor immediately.
Most patients are able to get back to their normal daily activities immediately after treatment. Make-up may be applied within a few hours after treatment if no bleeding or open wounds are present.
For more information, please visit www.sculptra.us