Sculptra

Medication: SCULPTRA (injectable poly-L-lactic acid)

WHAT IS SCULPTRA?

SCULPTRA is an injectable biodegradable material that is made of very small particles of a synthetic polymer named “poly-L-lactic acid” (PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (USP) and sterile water for injection (USP).

 

WHO MIGHT BENEFIT FROM TREATMENT WITH SCULPTRA?

SCULPTRA is injected in or under the facial skin through a small needle for correction of shallow to deep nasolabial fold, contour deficiencies and other facial wrinkles.

 

HOW OFTEN ARE SCULPTRA TREATMENTS GIVEN AND HOW MANY TREATMENTS ARE REQUIRED?

Your provider should see you at approximately 3-4 weeks after each treatment session to assess whether you need additional treatment. You may need 1-4 treatment sessions (typically 3) to achieve the optimal correction possible.

 

HOW DOES SCULPTRA WORK?

Collagen production in the body decreases as you get older and/or are exposed to the sun. Wrinkles are one of the first visible signs of this. SCULPTRA is injected into the deep layer of the skin where collagen naturally exists and is made. SCULPTRA works by initially filling a wrinkle with small PLLA beads. As the beads biodegrade the body may produce new collagen where SCULPTRA is injected. SCULPTRA is injected with multiple small injections using a fine needle in a grid pattern to correct a wrinkle at the nasolabial fold or other facial wrinkles where this injection technique is appropriate:

ARE THE RESULTS FROM SCULPTRA IMMEDIATE?

No. Unlike other wrinkle fillers, SCULPTRA provides a gradual improvement of the depressed area over several weeks. It may seem that your treatment worked immediately because of swelling caused by injection and the water used to dilute SCULPTRA. This usually resolves in several hours to a few days and may cause the original wrinkle to reappear: you may look as you did before your treatment. Visible wrinkle correction results appear slowly. Your healthcare provider should see you again in three or more weeks to decide if you need additional injections.

 

HOW LONG DO SCULPTRA TREATMENT EFFECTS LAST?

Results for some subjects lasted for up to 25 months after the last treatment session. However, the improvement depended on the severity of the nasolabial fold wrinkle (WAS score) that a subject had before treatment. Discuss with your health care provider the optimal cosmetic correction you may expect.

 

DO INJECTIONS OF SCULPTRA HURT?

As with any injection, to decrease pain during injection, a topical or a local anesthetic may be used when injecting SCULPTRA. In U.S. clinical study, subjects recorded pain in diaries: 71% of all treated patients reported some pain after first injection, 14% of subjects had moderate pain. Most pain resolved in less than 24 hours.

As with any injectable wrinkle filler, you can expect injection-related side effects, such as bleeding, tenderness or pain/discomfort, redness, bruising, or swelling. These side effects generally resolve within a few hours to a few days but could last for 14 days or longer.

 

Following your treatment

• Massage the treated area for 5 minutes 5 times per day for 5 days after your treatment.
• Within the first 24 hours after your treatment, apply ice or an ice pack wrapped in cloth (avoid putting ice directly on your skin) to the treatment area to help reduce swelling
• Avoid or minimize hard (strenuous) exercise and exposure to extensive sun, UV lamps, indoor tanning beds/booths, or extreme temperatures within the first 24 hours after treatment with SCULPTRA.
• Report any worsening or longer-lasting signs of symptoms to your healthcare provider.
• Seek immediate medical attention if you develop symptoms such as unusual pain, vision changes, a white appearance of skin near the injection site, or any signs of a stroke (including sudden difficulty speaking, numbness or weakness in your face, arms, or legs, difficulty walking, face drooping, severe headache, dizziness, or confusion) during or shortly after the procedure

 

HOW QUICKLY CAN I GET BACK TO MY DAILY ACTIVITIES?

Most patients are able to get back to their activities immediately following treatment.

 

WHEN WILL I BE ABLE TO APPLY MAKE-UP AFTER TREATMENT?

Make-up may be applied a few hours after treatment if there are no complications such as open wounds or bleeding.

There are a variety of dermal fillers available in the US. Prices, safety and effectiveness vary. Consult with your physician to determine which one is right for you.

You should not get SCULPTRA if you:

• Have severe allergies with a history of severe reactions (anaphylaxis) or multiple severe allergies. Use of SCULPTRA may result in an allergic reaction.
• Are allergic to any ingredient of SCULPTRA: “poly-L-lactic acid” (PLLA), carboxymethylcellulose (USP) or non-pyrogenic mannitol (USP).
• Previously had or have risks factors for hypertrophic scarring or keloid formation.