Sculptra Special Precautions

Health care practitioners are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.
This product should only be used by health care practitioners who have appropriate training, experience, and knowledge about the product use and the anatomy at and around the site of injection in order to minimise the risks of potential complications (such as formation of papules/nodules, perforation of vessels, or trauma to nerves and other vulnerable structures).
Injection procedures are associated with a risk of infection. Aseptic technique and standard practice to prevent cross-infections are to be followed.
Patients with bleeding disorders or patients using substances that affect platelet function, thrombolytics or anticoagulants may, as with any injection, experience increased bruising, haematoma or localised bleeding at injection site.
Interactions of Sculptra with previous implants, or concomitantly administered drugs other than lidocaine, have not been studied. Reconstituted Sculptra suspension mixed with devices or drugs other than lidocaine has not been studied.
Injection too superficially, or in facial areas with thin skin, such as the periorbital area, may result in contour irregularities and palpable lumps.
Injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
This product should be used with caution in patients on immunosuppressive therapy.
Patients with unattainable expectations are not suitable candidates for treatment.
Sculptra should not be used in patients with known history of, or susceptibility to, keloid formation or hypertrophic scarring. The safety of using Sculptra in such patients has not been established.
If laser treatment, chemical peeling or any other procedure based on active dermal response is performed after treatment with Sculptra, there is a possible risk of eliciting an inflammatory reaction at the implant site. This also applies if Sculptra is administered before the skin has healed completely after such a procedure.
The patient should avoid excessive sun, UV lamp exposure and extreme temperatures until any initial swelling and redness has resolved.
In addition the following precautions should be observed if lidocaine is added to the reconstituted Sculptra suspension prior to treatment: Only a sterile lidocaine solution should be added to the reconstituted Sculptra suspension just before the injection procedure and this should then be used within 72 hours. See Treatment procedure under Cautions for Usage for additional procedural information.
Consider safety risks associated with the use of lidocaine, including possible toxic effects in patients with increased sensitivity and accumulating levels of lidocaine if used concurrently with other administration. For specific safety information, refer to the product labelling for the lidocaine solution used.
Use in Pregnancy & Lactation: See USE IN PREGNANCY & LACTATION section for further information.
Use in Children: The safety of Sculptra for use in patients under 18 years has not been established.