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 [DSC]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
Onset of Action
Weeks to months for full effect of treatment
Use: Labeled Indications
Facial fat loss (lipoatrophy): Restoration and/or correction of the signs of facial fat loss (lipoatrophy) in patients with human immunodeficiency virus (HIV).
Facial wrinkles: 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
Dosage and Administration
Dosing: Adult
Facial fat loss (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.
Facial wrinkles (Sculptra Aesthetic): Intradermal: 0.1 to 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
Dosing: Geriatric
Refer to adult dosing.
Reconstitution
Slowly add 5 mL SWFI 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
For injection into deep dermis or subcutaneous layer using tunneling, threading, or depot technique. Avoid intravenous injection. Space injections 0.5 to 1 cm apart. Administer using 26 gauge 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 to 4 injections and for ≥2 minutes at the end of the treatment session to evenly distribute. Do not fully correct or overcorrect. Local or topical anesthetic may be used prior to injecting. See prescribing information for detailed administration technique.
Storage
Prior to reconstitution, store at room temperature, up to 30°C (86°F); do not freeze. Upon reconstitution, store for up to 72 hours at 5°C to 30°C.
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.
Disease related concerns:
- Bleeding disorders: Use with caution in patients with bleeding disorders and patients on anticoagulant therapy; may have increased risk of hematoma, bleeding, or bruising at injection site.
- Skin infection/inflammation: Patients with an active skin infection or inflammation skin eruptions (such as cysts, pimples, rashes, or hives) in or near the treatment area should not undergo treatment until the inflammatory or infectious process has been controlled. Treatment carries a risk of infection; utilize standard aseptic precautions during treatment.
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: 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. Safety and efficacy have not been established for use in larger amounts, at different frequencies, at sites other than deep dermis of nasolabial folds, with different techniques, or at sites with previous dermal fillers. Treatment for >25 months has not been studied. Concomitant use with laser, chemical peeling procedures, or other procedure may increase risk of inflammation at the implant site, especially prior to complete healing of the skin. Sculptra Aesthetic has not been evaluated in immunocompromised patients.
- Experienced physician: Should be administered by an experienced health care provider who has appropriate training, experience, and knowledge of anatomy at injection site, and knowledge of aseptic technique.
- Radiopaque: Patients should inform health care providers that they are receiving poly-L-lactic acid; microparticles of poly-L-lactic acid may be visible on CT scans, MRIs, ultrasound, or X-rays.
Pregnancy
Pregnancy Considerations
Reproduction studies have not been conducted. Safety for use in pregnant women 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?)
- Patient may experience bruising, tenderness, minor discomfort, or itching. Have patient report immediately to prescriber severe skin irritation, pain, edema, or bleeding (HCAHPS).
- 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 health care 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.
