Sculptra

What it is

Sculptra is a CE-marked (CE 0344) poly-L-lactic acid (PLLA) implant supplied as a sterile, non-pyrogenic dry powder that is reconstituted with sterile water for injection. The suspension contains microparticles of poly-L-lactic acid, a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family.

Intended use (per instructions for use)

Sculptra is suitable for increasing the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds and scars, and in skin ageing. Sculptra is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).

Composition

Each vial of dry powder contains poly-L-lactic acid 150 mg, sodium carboxymethylcellulose 90 mg and non-pyrogenic mannitol 127.5 mg.

Mode of action

According to the manufacturer, the particles provide soft tissue augmentation that improves over the course of a few weeks as the microparticles are gradually surrounded by host connective tissue.

Treatment

• Contents: 2 vials of dry powder. Sterile water for injection, syringes and needles are purchased separately.
• Reconstitution: 5–8 ml sterile water for injection per vial; optionally 1 ml 2% lidocaine.
• Injection: deep dermis or subcutaneous layer with a 25G or 26G needle. Limited correction at the first treatment; evaluation no sooner than four weeks. The amount and number of treatments depend on the patient's needs.

Important to know

For use only by healthcare professionals with appropriate training and knowledge of the product and the anatomy. Do not use in case of hypersensitivity to the constituents, lidocaine or amide-type anaesthetic hypersensitivity (if lidocaine is added), a history of severe allergies or anaphylaxis, or active disease, inflammation, infection or tumours in or near the treatment site. Do not use in patients with a known history of, or susceptibility to, keloid formation or hypertrophic scarring. Do not inject intramuscularly or intravascularly, and not into the red area of the lip. Unintentional injection into facial vessels may cause serious events including vision impairment, blindness and stroke. The safety of use during pregnancy, in breastfeeding women and in patients under 18 years has not been established. Vials are for single patient and single session use.

Storage and shelf life

The dry powder is stored at room temperature, away from heat (maximum 30 °C). After reconstitution the suspension can be stored for up to 72 hours in a refrigerator (2–8 °C) or at room temperature up to 30 °C. Do not freeze. Do not use after the expiry date.

Documentation and traceability

CE-marked (CE 0344). Manufacturer: Q-Med AB (Galderma), Seminariegatan 21, SE-752 28 Uppsala, Sweden. See the attached Norwegian instructions for use.

Composition per vial (dry powder): poly-L-lactic acid 150 mg, sodium carboxymethylcellulose 90 mg, non-pyrogenic mannitol 127.5 mg. 2 vials per box.

Reconstitute each vial immediately before use: add 5 ml sterile water for injection with an 18G needle, shake vigorously for about 1 minute, and if desired add up to 3 ml additional water (total 5–8 ml). Optionally, a further 1 ml sterile 2% lidocaine solution can be added (final volume 6–9 ml). The suspension can be used immediately or stored for up to 72 hours before injection. Draw up with an 18G needle, change to a 25G or 26G needle and inject into the deep dermis or subcutaneous layer. At the first treatment only a limited correction is made; evaluate the patient no sooner than four weeks later. Massage the treatment area thoroughly after injection; the patient massages for five minutes, five times daily for five days. Sterile water, syringes and needles are purchased separately. See the attached Norwegian instructions for use.