XIAFLEX is approved for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. XIAFLEX should be administered by a healthcare provider experienced in the treatment of male urological diseases, who has completed required training for use of XIAFLEX in the treatment of Peyronie's disease.
A REMS (Risk Evaluation and
Mitigation Strategy) is a strategy to manage known or potential
serious risks associated with a drug and is required by the Food and
Drug Administration (FDA) to ensure that the benefits of the drug
outweigh its risks. Endo Pharmaceuticals has worked with the FDA to
develop the XIAFLEX REMS Program.
The XIAFLEX REMS requires a review of educational materials, training, and certification.
XIAFLEX is available for the treatment of Peyronie's disease only through the XIAFLEX REMS Program. The XIAFLEX REMS Program requirements include:
To become certified in the XIAFLEX REMS Program, healthcare providers must read the prescribing information, take the training (video or guide) and complete the Enrollment Form.
To become certified in the XIAFLEX REMS Program, pharmacies and healthcare settings must complete the Pharmacy/Healthcare Setting Enrollment Form.
For more information about the XIAFLEX REMS Program, call
If you have product-related questions or to report adverse events, please contact the XIAFLEX Medical Information Call Center at 1-800-462-3636. Adverse events may also be reported to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.