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Poly-L-Lactic Acid

Pronunciation

(POL i el LAK tik AS id)

Index Terms

  • New-Fill®
  • PLA

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, powder for suspension:

Sculptra®, Sculptra® Aesthetic: Poly-L-lactic acid USP

Brand Names: U.S.

  • Sculptra®
  • Sculptra® Aesthetic

Pharmacologic Category

  • Cosmetic Agent, Implant

Pharmacology

Poly-L-lactic acid is an immunologically inert synthetic polymer. It increases dermal thickness by causing a local reaction leading to an increase in collagen deposits. It is eventually degraded and undergoes resorption.

Onset of Action

Weeks to months for full effect of treatment

Use: Labeled Indications

Restoration and/or correction of facial lipoatrophy in patients with HIV; correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in immunocompetent patients

Contraindications

Hypersensitivity to poly-L-lactic acid or any component of the formulation; history or susceptibility to hypertrophic scarring or keloid formation

Dosing: Adult

Facial wrinkles (Sculptra® Aesthetic): Intradermal: 0.1-0.2 mL per individual injection to a maximum of 2.5 mL per nasolabial fold as a single treatment; may repeat treatment at ≥3 week intervals up to 4 times

Lipoatrophy (Sculptra®): Intradermal or SubQ: ~0.05-0.2 mL per individual injection depending on technique used; ~20 injections may be needed per cheek. Treatment should be individualized. Separate treatments by ≥2 weeks. Typical course involves 3-6 treatments. Supplemental injections may be needed. Do not overfill contour deficiency. For patients with severe facial fat loss, the average treatment requires ~1 vial per cheek area per treatment.

Dosing: Geriatric

Refer to adult dosing.

Reconstitution

Slowly add 3-5 mL SWFI (Sculptra®) or 5 mL SWFI (Sculptra® Aesthetic) to vial and allow to stand for 2 hours to hydrate. Do not shake. After 2 hours, agitate vial until a uniform suspension is formed. Use within 72 hours. Discard unused portion.

Administration

Sculptra®: For injection into deep dermis or subcutaneous layer using tunneling, threading, or depot technique. For injection into deep dermis or subcutaneous layer. Avoid intravenous injection. Administer using 26 gauge needle; do not bend needle. Massage treatment area periodically during session to evenly distribute.

Sculptra® Aesthetic: For injection into the deep dermis using a tunneling/threading technique. Avoid intravenous injection. Space injections 0.5-1 cm apart. Administer using 26 gauge or larger needle; do not bend needle. Occasionally agitate syringe during session to maintain a uniform suspension. Eliminate air prior to initial injection. Stretch skin prior to inserting needle. Massage treatment area in a circular motion after every 3-4 injections and for ≥2 minutes at then end of the treatment session to evenly distribute. Do not fully correct or overcorrect. Local or topical anesthetic may be used prior to injecting.

Storage

Prior to and following reconstitution, store at room temperature, up to 30°C (86°F); do not freeze.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Dermatologic: Bruising (1% to 65%)

Hematologic: Hematoma (up to 28%)

Local: Injection site: Edema (3% to 81%), tenderness (81%), redness (78%), pain (71%), papules (3% to 52%), bleeding (34%), pruritus (20%), nodules (3%)

Miscellaneous: Discomfort (up to 19%)

1% to 10%:

Central nervous system: Fever (<5%)

Local: erythema (up to 10%), injection site reactions (<5%)

Postmarketing/case reports: Allergic reaction, angioedema, brittle nails, colitis, ectropion, fatigue, hair breakage, hypersensitivity reaction, hypertrophy, joint aches, malaise, periorbital nodules, photosensitivity, rash, scar/skin discoloration, skin infection, skin roughness, skin sarcoidosis, telangiectasia, urticaria, visible nodules

Injection site reactions: Abscess, atrophy, discharge, fat atrophy, granuloma, induration

Warnings/Precautions

Concerns related to adverse effects:

• Injection site reactions: Injection site reactions including, bleeding, bruising, edema, erythema, and inflammation, have occurred within days to months after injection.

• Photosensitivity: Patients should be instructed to limit exposure to excessive sunlight or UV lamps until any swelling or redness is resolved.

Concurrent drug therapy issues:

• Anticoagulants/antiplatelets: Use with caution in patients on anticoagulants or antiplatelet medications.

Special populations:

• Non-Caucasians: Safety and efficacy in non-Caucasians are limited.

• Women: Safety and efficacy are limited in women with HIV.

Other warnings/precautions:

• Administration: Avoid IV injection; may lead to occlusion, infarction, or embolism.

• Appropriate use: Not for use if skin inflammation or infection exists in or near the treatment area; control inflammation or infection before use. Avoid use with implants. Avoid overcorrection of contour deficit; improvement occurs over weeks of treatment. Safety and efficacy have not been established for use in the lips or periorbital area. Sculptra® Aesthetic has not been evaluated in immunocompromised patients.

Pregnancy Considerations

Safety for use during pregnancy has not been established.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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