How to Mix
Sculptra dry powder is reconstituted with 5–8 ml of sterile water for injection to form a sterile nonpyrogenic suspension. As an optional means to provide pain relief during the injection procedure, an additional 1 ml of sterile 2% (20 mg/ml) lidocaine solution may be added to the vial of reconstituted product prior to injection for a final volume of 6–9 ml (refer to Section “Treatment procedure”).
Injection Depth
Injection technique: Sculptra is injected into the deep dermis, subcutaneous layer or into the supraperiosteal plane with a 25G or 26G needle with sterile single-use syringes. The depth of injection and quantity of Sculptra used depends on the area to be treated and the results expected.
Contraindications
Do not use in patients with a history of hypersensitivity to any of the constituents of the product.
• Do not use reconstituted Sculptra product supplemented with lidocaine in patients with a history of hypersensitivity to lidocaine or other amide-type local anaesthetics.
• Do not use in patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
• Do not use when there is active disease, such as inflammation (skin eruption such as cysts, pimples, rashes or hives), infection or tumors, in or near the intended treatment site, until the underlying process has been controlled.
Warnings
Sculptra should only be used in the deep dermis, subcutaneous layer or in the supraperiosteal plane. Improper injection techniques such as superficial placement, excessive amount of product or incorrect reconstitution may lead to appearance of papules or nodules at the injection site. Massaging the treatment area to ensure proper distribution of the product may minimise the appearance of such papules or nodules.
• This product must not be injected intramuscularly or intravascularly. Localised superficial necrosis and scarring may occur after injection in or near vessels. It is thought to result from the injury, obstruction, or compromise of blood vessels. Special caution should be taken if the patient has undergone a prior surgical procedure in the planned treatment area. Areas with limited collateral blood flow has an increased risk of ischaemia. Aspiration prior to injection is recommended.
• Unintentional introduction of soft tissue fillers into the vasculature in the face may lead to embolisation, occlusion of the vessels, ischaemia, necrosis or infarction at the implant site or in the area supplied by the blood vessels affected. Rare but serious adverse events include temporary or permanent vision impairment, blindness, cerebral ischaemia or cerebral haemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if any of the following symptoms occurs, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist, should an intravascular injection occur.
• Do not over-correct (overfill) a contour deficiency, because the depression should gradually improve within several weeks as the treatment effect of Sculptra occurs. If an overcorrection occurs, the area concerned should be thoroughly massaged to ensure proper distribution of the product.• Do not inject into the red area of the lip (vermillion).
• Sculptra vials are for single patient and single session use only in order to avoid contamination. Discard immediately after use. Do not reuse or do not resterilize the vial. Do not use if package or vial is opened or damaged.
• Always reconstitute the powder with sterile water for injection.
Additional Points:
- Sculptra vials are for single patient and single session use only[4].
- The product should not be injected into the vermillion border of the lips[4].
Citations:
[1] https://www.sculptrausa.com/sites/default/files/2023-09/Sculptra-e-IFU-USA.pdf
[2] https://nationallaserinstitute.com/blog/cosmetic-laser-training/intro-to-sculptra-training/
[3] https://www.accessdata.fda.gov/cdrh_docs/pdf3/P030050S039C.pdf
[4] https://www.galderma.com/au/sites/default/files/Sculptra%20IFU_Aug21.pdf
[5] https://www.galderma.com/us/sites/default/files/2019-04/Patient_Brochure_Sculptra_Aesthetic_US_0.pdf
[6] https://www.accessdata.fda.gov/cdrh_docs/pdf3/p030050s002c.pdf
[7] https://www.themasterinjector.com/6-sculptra-injection-secrets-from-the-master-injector/
[8] https://www.youtube.com/watch?v=SEZZ8euzX-w