Dosing & Uses
Dosage Forms & 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
Safety and efficacy not established
Adverse 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 & 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
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
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Formulary
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