poly-L-lactic acid/carboxymethylcellulose/mannitol (Sculptra Aesthetic)

Dosing and uses of Sculptra Aesthetic (poly-L-lactic acid/carboxymethylcellulose/mannitol)

• Adult
• Pediatric

 

Adult dosage forms and strengths

intradermal suspension

• 367.5mg/vial (reconstitution required)

 

Nasolabial Fold Contour Deficiencies

Indicated as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles

Inject using threading or tunneling technique in grid pattern

May use up to 4 sessions with 3 week intervals

Typical injection amount/site is 1 mL

Maximum injection is 2.5 mL/site

 

Dosing Considerations

For immunocompetent individuals only

Patient must be an appropriate candidate for deep dermal grid pattern (cross-hatch) injection technique

Intended for Wrinkle Assessment Scores (WAS) between 2-4

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Sculptra Aesthetic (poly-L-lactic acid/carboxymethylcellulose/mannitol) adverse (side) effects

1-10%

Injection site pain (9.5%)

Injection site nodule (8.6%)

Injection site papule (8.6%)

Nasopharyngitis (6%)

Headache (4.3%)

Injection site erythema (3.4%)

Acne (2.6%)

Pain (2.6%)

Injection site hemorrhage (1.7%)

Swelling (1.7%)

 

Postmarketing Reports

Allergic reaction

Angioedema

Hypertrophy of skin

Injection site discharge, abscess, atrophy, granuloma, and induration

 

Warnings

Contraindications

Hypersensitivity to components

Known history of or susceptibility to keloid formation

 

Cautions

Unique injection requirements which include tunneling technique in grid pattern; use only by physician trained with technique

Do not overcorrect contour deficiency; facial depression expected to gradually improve over several weeks

Do not inject in blood vessels; may cause vacular occlusion, infarction, or emboli

Defer injection if treatment area is inflamed (eg, cysts, pimples, rash, hives) or infected

Injection site reactions include delayed occurrence of papules, nodules, hematoma, bruising-ecchymosis, bleeding, edema, discomfort, inflammation, and erythema

Safety and efficacy has not been established for use in the lips, periorbital area, during pregnancy or lactation, or in individuals with history of keloid formation, hypertrophic scarring, connective tissue disease, active inflammatory conditions, bleeding disorders, active hepatitis, serious abnormalities in lab findings (eg, cancer, stroke, MI), on any immunosuppressive therapy, and/or with any other prior or concomitant treatment at the treatment site

The microparticles may be visible on CT scans, MRI, or by other imaging techniques

Embolization

• Rare, but serious, injuries may occur as a result of unintentional injection of a soft tissue filler into blood vessels in the face
• May result in restricted blood supply to tissues and lead to embolization, which could cause vision impairment, blindness, stroke, and damage and/or necrosis of the skin and underlying facial structures

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Unknown whether distributed in breast milk

 

Pregnancy categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

 

Pharmacology of Sculptra Aesthetic (poly-L-lactic acid/carboxymethylcellulose/mannitol)

Mechanism of action

Biodegradable injectable implant containing microparticles of poly-L-lactic acid, carboxymethylcellulose, and mannitoL

 

Administration

Preparation

Using 5 mL syringe with 18 ga needle, draw 5 mL of sterile water for injection (SWI) into syringe

Slowly add all SWI into aseptically prepared vial of freeze-dried Sculptra

Let vial stand for at least 2 hr to ensure complete hydration; do not shake during this period

Product should be gently agitated immediately prior to use; agitate vial until a uniform translucent suspension is obtained

 

Injection

Inject using a sterile 26 ga needle in order to maintain a uniform suspension throughout the procedure

Intermittently agitate suspension in the syringe

Replace needle if occlusion occurs of if the needle becomes dull during the procedure

Inject into deep dermis with tunneling (threading) technique

Create firm needle insertion plane by stretching the skin

Introduce needle bevel-up at ~30-40 degree angle to the skin and then advance the needle to the deep dermis until desired skin depth is reached

Inject with threading or tunneling technique in grid pattern

Do not fully or overcorrect; undercorrection is desired to allow area for gradual improvement of contour deficiency since the effects occur over a minimum of 3 weeks

Massage treatment area to ensure proper distribution and minimize nodule appearance

 

Storage

Unreconstituted vial: Store at room temperature, up to 30 degrees C (86 degrees F)

Reconstituted vial: May store up to 72 hr without refrigeration (5-30 degrees C); do not store suspension in syringe

Single use vial, discard any material remaining after use or after 72 hr following reconstitution