Sculptra® (2 vials × 5 ml)

Sculptra®

Medical device – Biostimulatory dermal filler

Injectable poly\u2011L\u2011lactic acid (PLLA) collagen stimulator

FDA Approved PLLA injectable for facial wrinkles, fat loss and volume correction. :contentReference[oaicite:31]{index=31}
CE‑marked medical device in EU/UK markets per manufacturer distribution and regulatory conformity. :contentReference[oaicite:32]{index=32}

FDA Approved PLLA injectable for facial wrinkles, fat loss and volume correction. :contentReference[oaicite:31]{index=31}
CE‑marked medical device in EU/UK markets per manufacturer distribution and regulatory conformity. :contentReference[oaicite:32]{index=32}

Injectable poly\u2011L\u2011lactic acid (PLLA) collagen stimulator

Description

Sculptra® is an injectable biostimulatory implant containing microparticles of poly‑L‑lactic acid (PLLA), sodium carboxymethylcellulose and non‑pyrogenic mannitol, supplied as sterile lyophilized vials. Prior to injection, each vial must be reconstituted with sterile water for injection (SWFI). Upon injection into the deep dermis, subcutaneous tissue or supraperiosteal plane, PLLA microparticles stimulate fibroblast activity and gradual collagen production, leading to progressive restoration of facial volume and reduction of wrinkles, folds and facial depressions. Effects develop over weeks to months, yielding a more natural volumizing outcome compared with immediate‑effect fillers. :contentReference[oaicite:0]{index=0}

Bnefits

Stimulates natural collagen production to restore facial volume progressively. :contentReference[oaicite:1]{index=1}
Long-lasting effects — with full treatment protocol results may last up to 24 months. :contentReference[oaicite:2]{index=2}
Suitable for large-volume corrections, facial fat-loss (lipoatrophy), and deep wrinkles/folds rather than just superficial lines. :contentReference[oaicite:3]{index=3}
Biocompatible, biodegradable, synthetic polymer — no human/animal-derived collagen required. :contentReference[oaicite:4]{index=4}

Indications

Correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in immune‑competent individuals. :contentReference[oaicite:5]{index=5}
Correction of fine lines and wrinkles in the cheek region (cheek augmentation / wrinkle treatment). :contentReference[oaicite:6]{index=6}
Restoration and/or correction of facial fat loss (lipoatrophy), including age‑related volume loss and HIV-associated facial lipoatrophy (per earlier approvals). :contentReference[oaicite:7]{index=7}

Composition

Poly‑L‑lactic acid (PLLA) — 150 mg per vial. :contentReference[oaicite:8]{index=8}
Sodium carboxymethylcellulose (USP) — 90 mg per vial (suspension agent). :contentReference[oaicite:9]{index=9}
Non‑pyrogenic mannitol (USP) — 127.5 mg per vial (stabilizer). :contentReference[oaicite:10]{index=10}
Sterile water for injection (SWFI) added at time of reconstitution. :contentReference[oaicite:11]{index=11}

Formulation

Sterile, non‑pyrogenic lyophilized powder in a glass vial for reconstitution. :contentReference[oaicite:12]{index=12}
Reconstituted with 5–8 ml sterile water for injection (SWFI) to form a suspension prior to injection. Optionally, up to 1 ml of 2% lidocaine solution may be added just before injection for patient comfort. :contentReference[oaicite:13]{index=13}

Packaging

Each box contains 2 vials of 5 ml lyophilized powder (total 2 vials). :contentReference[oaicite:14]{index=14}
Vials are single-use only, glass vials with rubber stopper and flip-top cap, supplied sterile. :contentReference[oaicite:15]{index=15}

Usage

Reconstitute each vial with 5–8 ml sterile water for injection to form a sterile suspension; optional addition of up to 1 ml 2% lidocaine for comfort immediately before injection. :contentReference[oaicite:16]{index=16}
Inject only by trained, licensed healthcare practitioners into the deep dermis, subcutaneous or supraperiosteal plane using sterile single‑use syringes and 25G or 26G needles. :contentReference[oaicite:17]{index=17}
For initial session, perform conservative correction; re-evaluate patient no sooner than four weeks before additional sessions. Full treatment protocol typically involves multiple sessions spaced several weeks apart. :contentReference[oaicite:18]{index=18}

Contraindications

Known hypersensitivity to any component of Sculptra Aesthetic. :contentReference[oaicite:21]{index=21}
History of keloid formation or hypertrophic scarring. :contentReference[oaicite:22]{index=22}
Active skin disease, infection, inflammation or acne in treatment area — postpone until resolved. :contentReference[oaicite:23]{index=23}
Should not be injected into the red area (vermilion) of the lip or peri‑orbital area. :contentReference[oaicite:24]{index=24}
Not established for use in patients under 18 years, pregnant or breastfeeding individuals. :contentReference[oaicite:25]{index=25}

Adverse Effects

Common local reactions: swelling, redness, pain, bruising, bleeding, tenderness, itching at injection site. :contentReference[oaicite:26]{index=26}
Small nodules or lumps under the skin — sometimes noticeable on pressure; larger or delayed-onset nodules have been reported, occasionally with inflammation or skin discoloration. :contentReference[oaicite:27]{index=27}
Risk of vascular occlusion if injected intravascularly; avoid injection into vessels. :contentReference[oaicite:28]{index=28}

Storage Conditions

Store unopened vials at controlled room temperature (per manufacturer label) before reconstitution. :contentReference[oaicite:29]{index=29}
After reconstitution, the suspension should be used promptly; do not freeze. :contentReference[oaicite:30]{index=30}

Duration

Up to 24 months (with full treatment protocol). :contentReference[oaicite:19]{index=19}

Onset

Gradual onset \u2014 visible improvements generally begin in 4\u20136 weeks, with results building over months as new collagen forms. :contentReference[oaicite:20]{index=20}