What is XIAFLEX
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.
What is the XIAFLEX REMS
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.
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. The XIAFLEX REMS requirements include:
- Training for healthcare providers on the risks of corporal rupture and other serious injuries to the penis that can occur with XIAFLEX treatment, such as severe penile hematoma or ecchymoses, skin and soft tissue necrosis, swelling, and pain.
- Certification in the XIAFLEX REMS by completing training and enrollment in the program.
- Patient counseling about the risks of corporal rupture and other serious injuries to the penis that can occur with XIAFLEX treatment, such as severe penile hematoma or ecchymoses, skin and soft tissue necrosis, swelling, and pain as well as the importance of patient adherence to post-injection instructions. Healthcare Providers must give patients the Patient Counseling Tool, "What You Need to Know About XIAFLEX Treatment for Peyronie's Disease: A Patient Guide", after each XIAFLEX injection.
- Restricted Distribution through specially certified healthcare settings (e.g., pharmacies, practitioners, hospitals or outpatient settings).
Healthcare Provider Certification
To become certified in the XIAFLEX REMS, healthcare providers must read the prescribing information, take the training (video or guide) and complete the Enrollment Form.
Pharmacy / Healthcare Setting Certification
To become certified in the XIAFLEX REMS, pharmacies and healthcare settings must complete the Pharmacy / Healthcare Setting Enrollment Form.
For more information about the XIAFLEX REMS, call 1-877-313-1235.
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