Poly-L-Lactic acid

Pronunciation: PAHL-ee EL LACK-tick AH-sid
Class: Physical adjunct

Trade Names

Sculptra
- Powder for Injection, freeze dried.

Pharmacology

Injectable implant of microparticles of poly-L-lactic acid.

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Indications and Usage

Restoration and/or correction of signs of facial fat loss (lipoatrophy) in people with HIV.

Contraindications

Standard considerations.

Dosage and Administration

Adults

Deep Dermal or Subcutaneous Quantity and number of injection sessions vary by patient. Typical treatment course for severe facial fat loss involves 3 to 6 injection sessions separated by 2 or more wk. Full effects of treatment course are evident within weeks to months. Reevaluate patient no sooner than 2 wk after each injection session to determine need for additional correction.

General Advice

  • For mid to deep dermal or subcutaneous injection only. Not IM or IV administration.
  • Reconstitute powder for injection with 3 to 5 mL sterile water for injection. Slowly add desired volume of sterile water for injection into vial and allow vial to stand, without agitation or shaking, for at least 2 h to ensure complete hydration. After waiting at least 2 h, and immediately before use, agitate vial (a single vial swirling agitator may be used) until a uniform suspension is obtained.
  • Carefully follow manufacturer's guidelines for transferring suspension from vial to syringe used for injection, administration and injection technique, and posttreatment care (eg, ice pack to reduce swelling, thorough massage to evenly distribute product).
  • Do not inject poly-L-lactic acid using needles with an internal diameter smaller than 26-gauge.
  • Do not mix with other products prior to injection.
  • Assess injection site prior to administration. Avoid injecting into site with infection, skin disease, or active inflammatory process (eg, cysts, rash).

Storage/Stability

Store unopened vials of powder for injection and reconstituted suspension at controlled room temperature (less than 86°F). Protect from freezing. Do not store reconstituted suspension in syringe. Administer suspension within 72 h of reconstitution. Discard any material remaining after use or after 72 h following reconstitution.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Fatigue, malaise (postmarketing).

Dermatologic

Bruising, erythema; application-site discharge, ectropion, hypertrophy of skin, injection-site abscess, atrophy, fat atrophy, granuloma, skin rash and roughness, telangiectasias, visible nodules with or without inflammation or dyspigmentation, brittle nails, hair breakage (postmarketing).

Local

Discomfort; hematoma; inflammation; injection-site bleeding, induration, infection, lesion, and tenderness; injection-site subcutaneous papule.

Musculoskeletal

Aching joints (postmarketing).

Miscellaneous

Fever; allergic reaction, angioedema, colitis, hypersensitivity, photosensitivity, Quincke edema (postmarketing).

Precautions

Pregnancy

Not established.

Lactation

Undetermined.

Children

Safety and efficacy not established.

Special Risk Patients

Risk of hematoma or localized bleeding at injection site may be increased in patients taking anticoagulants.

Keloid formation/hypertrophic scarring/periorbital area

Safety not established for use in these conditions.

Long-term use

Safety and efficacy beyond 2 yr not established.

Skin inflammation/infection

Defer treatment until inflammation or infection process in or near treatment area has been controlled.

Treatment effect

Do not overcorrect a contour deficiency because depression should gradually improve within several weeks as treatment effect occurs.

Patient Information

  • Advise patient that treatment course may consist of 3 to 6 injection sessions separated by 2 or more wk. Explain importance of completing entire treatment course in order to obtain maximal benefit and advise patient that supplemental injection sessions may be required to maintain an optimal treatment effect.
  • Advise patient that medication will be prepared and administered in a health care setting by a health care provider.
  • Advise patient to review patient information sheet before starting therapy.
  • Advise patient to apply an ice pack (avoiding direct contact of ice with skin) to treatment area for a few minutes at a time for the first 24 h following injection session to reduce swelling.
  • Advise patient to massage treatment area a few times each day for several days following injection session to promote a natural looking correction.
  • Advise patient that mild to moderate treatment area reactions (eg, redness, swelling, bruising) are common and should resolve within hours to a week but to notify health care provider if treatment area reaction does not resolve or worsens.
  • Advise patient that original skin depression may initially reappear, but the depression should gradually improve within several weeks as the beneficial effect of the medication occurs.
  • Advise patient that small bumps may develop in the treatment area within 6 to 12 mo after the first treatment session. Advise patient that the bumps may not be visible and are only noted when pressing on the treatment area, or, they may become visible and eventually go away on their own. Advise patient to notify health care provider if visible bumps develop and are associated with redness or color change to treated area.
  • Caution patient to minimize exposure of treatment area to excessive UV light (eg, sunlight, tanning lamps) until any initial redness and swelling have resolved.
  • Advise patient that make-up may be applied a few hours after treatment session if no complications (eg, open wound, bleeding, redness, swelling).

Copyright © 2009 Wolters Kluwer Health.

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