SCULPTRA® 2 vials

SCULPTRA Aesthetic is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.

• SCULPTRA Aesthetic is intended for use in people with healthy immune systems as a one-time treatment regimen of up to 4 injection sessions that are scheduled about 3 weeks apart for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
• SCULPTRA Aesthetic may provide cosmetic correction of facial wrinkles with a Wrinkle Assessment Score of 2, 3, or 4.

• SCULPTRA® Aesthetic is an injectable implant containing microparticles of poly-L-lactic acid (PLLA), carboxymethylcellulose (USP), non-pyrogenic mannitol (USP), and sterile water for injection (USP).
• SCULPTRA Aesthetic is available in 367.5 mg dose vials and is to be reconstituted prior to use by the addition of 5 mL of Sterile Water for Injection, USP (SWFI) to form a sterile non-pyrogenic suspension.

Treatment Planning: Identify the areas of the face that would benefit from volume restoration. Sculptra is particularly effective for treating deep lines, creases, and folds, and can also be used for overall facial rejuvenation.

Preparation: Cleanse the treatment area thoroughly. Although Sculptra contains lidocaine to minimize discomfort, consider applying a topical anesthetic if the patient has low pain tolerance.

Injection Technique: Inject Sculptra into the deep dermis or subcutaneous layer using either a needle or a cannula. The product should be distributed evenly across the treatment area. The precise injection technique (linear threading, cross-hatching, or depot) will depend on the area being treated and the desired outcome.

Post-Injection Massage: Instruct the patient to massage the treated areas for five minutes, five times a day, for five days after the treatment. This helps to distribute the product and minimize the risk of nodule formation.

Contraindications

• SCULPTRA Aesthetic should not be used in any person who has hypersensitivity to any of the components of SCULPTRA Aesthetic (see DEVICE DESCRIPTION).
• SCULPTRA Aesthetic should not be used in patients with known history of or susceptibility to keloid formation or hypertrophic scarring.

After-care

Your healthcare provider will give you specific post-treatment care instructions. Some specific instructions you should follow after treatment are:

• 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 sun and UV sun lamp exposure until swelling and redness have disappeared.
• 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.