The following are important treatment considerations for you to discuss with your doctor and understand to help avoid unsatisfactory results and complications.
- SCULPTRA has not been studied under the age of 18.
- Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. The safety of SCULPTRA has not been studied in pregnant or breastfeeding women.
- Tell your doctor if you are taking medications to decrease the body’s natural defense system (immunosuppressants). SCULPTRA injections may then result in an increased risk of infection.
- Tell your doctor if you have a bleeding disorder or are taking medication that can thin your blood or prolong bleeding, such as aspirin and warfarin. As with any injection procedure, this may increase your risk of bruising or bleeding at the injection site.
- Avoid or minimize hard (strenuous) exercise and exposure to extensive sun, UV lamps, indoor tanning beds/booths, or extreme temperatures within 24 hours after treatment with SCULPTRA. Any of these may cause temporary redness, swelling, pain, and/or itching at the injection site.
- Tell your doctor if you have recently had skin therapies such as laser treatment, mechanical or chemical peels, or hair removal. This may lead to an increased risk of side effects such as redness, swelling, heat, or pain in the skin.
If you have any additional questions about any topic in this section, please discuss it further with your doctor.
In addition to the other information in this guide, you should be aware of the following: It is unknown whether SCULPTRA may be seen during radiologic imaging of your face, and SCULPTRA may be visible via ultrasound and MRI. If you have an ultrasound or MRI performed on the area injected with SCULPTRA, inform your healthcare provider that you have SCULPTRA injected. In an animal study, SCULPTRA implants were observed in 100% of the animals via MRI and ultrasound imaging 24 hours after injection. Ninety (90) days after injection, SCULPTRA was observed in 30% of the animals via ultrasound and no animals via 4 (10) MRIs. SCULPTRA was not served at either time point via CT scan or standard, plain radiography.