SCULPTRA poly-L-lactic acid – 2 vials

What is SCULPTRA poly-L-lactic acid?

The application of the product, Sculptra poly-L-lactic acid, is reserved exclusively for professional health workers with adequate qualifications.

MEDICAL DEVICE

SCULPTRA® Aesthetic (injectable poly-L-lactic acid)

The SCULPTRA Aesthetic implant package (i.e., lyophilized vials) is provided sterile.

Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed physician or properly licensed practitioner.

Information for the use of SCULPTRA Aesthetic is provided in this Labeling for Physicians and the Instructions for Use, as well as in Labeling for Patients. BEFORE USING SCULPTRA Aesthetic PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY.

DEVICE DESCRIPTION Sculptra poly-L-lactic acid 

Sculptra poly-L-lactic acid 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.

INTENDED USE / INDICATIONS

Sculptra poly-L-lactic acid 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. (This corresponds to Wrinkle Assessment Scores (WAS) of 2 to 4 in Figure 2 and the cross-hatch injection technique presented in Figures 3-7 in the Instructions for Use Section).

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.

WARNINGS Sculptra poly-L-lactic acid

• SCULPTRA Aesthetic has unique injection requirements, which include injection with tunneling technique in a grid pattern that is medial to the nasolabial fold contour defect that is to be corrected (see Figures 3-7 in the INSTRUCTIONS FOR USE). The safety of other methods of injection has not been evaluated in clinical studies.

• Do not overcorrect (overfill) the contour deficiency of the nasolabial fold contour defect because the depression is expected to gradually improve during several weeks after injection as the treatment effect of SCULPTRA Aesthetic occurs (see INSTRUCTION FOR USE – Patient Treatment).

• SCULPTRA Aesthetic must not be implanted into blood vessels.

• Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers, for example inject the product slowly and apply the least amount of pressure necessary. Rare but serious adverse events associated with the intravascular injection of soft tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.

• SCULPTRA Aesthetic use at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes or hives) or infection is present should be deferred until the inflammatory process has resolved and is controlled.

• Injection site reactions to SCULPTRA Aesthetic have included delayed occurrence of subcutaneous papules and nodules, hematoma, bruising-ecchymosis, bleeding, edema, discomfort, inflammation, and erythema. The subcutaneous papules and nodules were often confined to the injection site, typically palpable, asymptomatic and non-visible, occurring days to months after injection and had a prolonged time course to resolution. See ADVERSE EVENTS section for details.

• The kinetics of SCULPTRA Aesthetic resorption in humans has not been determined. In an intradermal implantation study in rabbits all animals had “several relatively large remnants” of injectable PLLA visible at 64 weeks after implantation. The tissue response to injectable PLLA was generally greater than the vehicle or negative plastic controls and was described as a chronic, granulomatous reaction characterized by foreign body giant cells and macrophages. The tissue reaction was confined to the area between particles, did not involve the surrounding tissue and was not unexpected, because it was consistent with the persistent and particle nature of injectable PLLA.

PRECAUTIONS

• SCULPTRA Aesthetic should only be used by a health care practitioner trained to correct shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate after the health care practitioner is fully familiar with the product, WAS, product educational materials, and the entire package insert and patient labeling.

• In order to minimize the risks of potential complications, this product should only be used by health care practitioners who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection.

• Health care practitioners are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.

• The safety and effectiveness of injecting Sculptra Aesthetic: 1) in larger amounts, 2) at different frequencies, 3) at anatomic sites different than the deep dermis of the nasolabial folds, 4) with different techniques, or 5) at anatomic sites that have had previous dermal filler injections, (including previous SCULPTRA Aesthetic injection), have not been evaluated.

• Long term safety and effectiveness of SCULPTRA Aesthetic beyond 25 months after last injection have not been investigated in clinical trials.

• The safety and effectiveness of SCULPTRA Aesthetic for use in the lips has not been evaluated. Do not inject into the red area (vermillion) of the lip.
• SCULPTRA Aesthetic should be injected into the deep dermis. Superficial injections may be associated with increased local adverse events such as nodules and papules. Take special care when using SCULPTRA Aesthetic in patients with thin skin. Please refer to PATIENT TREATMENT for injection technique instruction.

• SCULPTRA Aesthetic injection in the peri-orbital area has not been studied. An increased risk of papules and nodules has been reported in published literature after injections in the periorbital area.

• Safety and effectiveness of SCULPTRA Aesthetic has not been evaluated in subjects who are pregnant, lactating, breast feeding, or under 18 years of age.

• Safety and effectiveness of SCULPTRA Aesthetic has not been evaluated in subjects with the following: history of keloid formation, hypertrophic scarring, connective tissue disease, active inflammatory conditions, bleeding disorders, active hepatitis, serious abnormalities in laboratory findings, disease such as cancer, stroke and/or myocardial infarction, on any immunosuppressive therapy, and/or with any other prior or concomitant treatment at the SCULPTRA Aesthetic treatment site.

• Safety and effectiveness of SCULPTRA Aesthetic has not been systematically evaluated with local anesthetics, other drugs or devices used during the same treatment session. The safety and effectiveness of the volume ratio of SCULPTRA Aesthetic mixed with local anesthetic or any drug or device has also not been assessed.

• Other filler products should not be directly mixed with SCULPTRA Aesthetic. No studies of interactions of SCULPTRA Aesthetic with drugs or other substances or implants have been made.

• The volume of SCULPTRA Aesthetic injection per surface area of a tunneling or threading injection grid has not been assessed for any WAS.

• It is not known whether SCULPTRA Aesthetic is radiopaque in humans. The microparticles of SCULPTRA Aesthetic may be visible on computer tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound or standard, plain radiography. Patients should be informed that the device may be radiopaque, so that they can inform their health care professionals, including radiologists. In an animal study, SCULPTRA Aesthetic implants were observed in 10/10 rats via MRI and ultrasound imaging 24 hours after subcutaneous injection. Ninety (90) days after injection, SCULPTRA Aesthetic was observed in 3/10 rats via ultrasound and no animals via MRI. SCULPTRA Aesthetic was not observed at either time point via CT scan or standard, plain radiography.

• Safety and effectiveness data from clinical trials of SCULPTRA Aesthetic in nonCaucasians are limited.

• As with all transcutaneous procedures, SCULPTRA Aesthetic injection carries a risk of infection. Standard precautions to minimize infections associated with intradermal injectable materials should be followed.

• As with all injections, patients with coagulation defects or on concurrent anti-coagulant therapy are at increased risk for hematoma formation, bruising and/or bleeding at the injection site.

• As with all invasive procedures, SCULPTRA Aesthetic sessions should be conducted with aseptic technique. Observe universal precautions to minimize risks of potential contact with patient body fluids such as blood at the injection site.

• After use, treatment syringes and needles are considered contaminated biohazards. Handle and dispose contaminated syringes and needles in accordance with accepted medical practice and applicable local, state and federal requirements.

• The patient should be informed that he or she should minimize exposure of the treatment area to sun and avoid UV lamp exposure until any initial swelling and redness has resolved.

• If laser treatment, chemical peeling or any other procedure based on active dermal response is considered after treatment with SCULPTRA Aesthetic, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if SCULPTRA Aesthetic is administered before the skin has healed completely after such a procedure.

• SCULPTRA Aesthetic vials are for single patient use only. Do not reuse or resterilize the vial. Do not use if the package or vial is opened or damaged.

ADVERSE EVENTS

Clinical Trial

Controlled phase study (0-13 months)

A prospective, randomized clinical study was conducted at 10 centers in the US. Two hundred and thirty three (233), immune-competent and non-pregnant and non-breast feeding subjects with previously untreated nasolabial fold wrinkles and WAS of 2 through 4 received bilateral injections of either SCULPTRA Aesthetic or Cosmoplast in both nasolabial fold wrinkles during a maximum of 4 sessions over 9 weeks. Study treatment was planned to be stopped when the right and left nasolabial fold wrinkle reached WAS of 1 or 0, or the maximum of 4 treatment sessions were completed. Adverse events reported in subject.