Adult Dosing

Correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles

• 0.1-0.2 mL per injection to a maximum of 2.5 mL per nasolabial fold as a single treatment
• May repeat at 3 week intervals up to 4 times.

• 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.

• Hypersensitivity to any of the ingredients of the product
• History of or susceptibility to keloid formation or hypertrophic scarring

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Do not overfill the area to be treated because the depression is expected to gradually improve during several wks after the injection
• Do not implant poly-l-lactic acid in blood vessels as it may cause vascular occlusion, infraction or embolic phenomena
• Do not use at active inflammatory site or if infection is present until the inflammatory process is resolved and is controlled
• Therapy may cause injection site reactions such as delayed occurrence of subcutaneous papules and nodules, hematoma, brushing-ecchymosis, bleeding, edema, discomfort, inflamtion, erythema
• Poly-l-lactic acid should be used only by the trained physician and who is familiar with the product
• Safety and effectiveness of poly-l-lactic has not been established in larger amounts, at different frequencies, when used at anotomic sites other than the deep dermis of the nasolabial folds, and when used with different techniques.
• Safety and effectiveness of poly-l-lactic acid for >25 months has not been evaluated
• The safety and effectiveness of poly-l-lactic acid aesthetic for use in the lips is not established. Avoid injection of this drug into the red area (vermillion) of the lip
• Inject this drug into the deep dermis. Increased local adverse events such as nodules and papules are associated with superficial injections. Take utmost care when using this aesthetic in patients with thin skin
• Use of this aesthetic injection in the peri-orbital area has not evaluated. Increased risk of papules and nodules are associated with injections in the periorbital area
• Safety and effectiveness of this aesthetic has not been evaluated in subjects who are pregnant, lactating, breast feeding, or <18 yrs of age
• Safety and effectiveness of this aesthetic drug is not established in subjects having 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 concurrent treatment at the aesthetic treatment site
• Safety and effectiveness of this aesthetic drug is 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 poly-l-lactic acid aesthetic mixed with local anesthetic or any drug or device has also not been evaluated
• Avoid direct mixing of other filler products with this aesthetic. Interaction studies with drugs or other substances or implants have not been evaluated
• The volume of this aesthetic injection per surface area of a tunneling or threading injection grid has not been evaluated for any WAS
• Unknown whether this aesthetic drug is radiopaque. The microparticles of this aesthetic drug may be visible on computer tomography (CT) scans, magnetic resonance imaging (MRI), ultrasound or standard, plain radiography. Inform patients that the device may be radiopaque, so that they can inform their health care professionals, including radiologists
• Safety and effectiveness of this aesthetic drug in non-caucasians is limited
• Risk for development of infections exists. Undertake standardized precautions for minimizing infections associated with intradermal injectable materials
• Inform patients to minimize exposure of the treatment area to sun and avoid UV lamp exposure until any initial swelling and redness has resolved

Pregnancy Category: Not available

Breastfeeding: Safety unknown.

• LOCAL: localized swelling, localized tenderness, post injection site pain, localized bruising, bleeding from site(s), localized itching, nodules, papules, lumps, localized redness, injection site erythema, injection site dermatitis, injection site hemorrhage, application site dryness,injection site discoloration
• CV: Hypertension
• DERM: Acne, pain, sinusitis
• CNS: Headache, syncope vasovagal
• RESP: Cough, bronchitis, URTI
• GU: UTI
• EENT: Nasopharyngitis, tooth abscess
• MISC: Fracture, streptococcal infection, influenza

• Synthetic biodegradable polymer; initiate neocollagenesis as a result of a normal foreign-body reaction to their presence
• MEtabolism: Unknown
• Excretiion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Sculptra

US Availability

Sculptra

• PWD for INJ: 367.5 mg/vial

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

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