Approved Risk Evaluation and Mitigation Strategies (REMS)

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Xiaflex (collagenase clostridium histolyticum)
BLA #125338
REMS last update: 10/20/2014

View the Xiaflex Prescribing Information and Medication Guide at DailyMed.
View Xiaflex's Regulatory Information at Drugs@FDA

What do participants need to know?

Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Healthcare Providers who prescribe Xiaflex

To be able to prescribe Xiaflex
  • Review the prescribing information for Xiaflex.
  • Review the educational materials for prescribers, including: Healthcare Provider Training for Peyronie’s disease and Patient Counseling Tool.
  • Enroll in the REMS by completing and submitting the Healthcare Provider Enrollment Form for Peyronie’s disease.
Before writing the first prescription for a patient
  • For a patient with Peyronie’s disease: counsel the patient on the risks associated with the use of the medication and the need to follow important post-injection instructions using the Patient Counseling Tool.
  • Provide the patient with a copy of the Patient Counseling Tool.

Healthcare settings and pharmacies that dispense Xiaflex

To be able to dispense Xiaflex
  • Designate an authorized representative to carry out the certification process on behalf of the healthcare setting.
  • Establish processes and procedures to verify that prescribers are certified.
  • Enroll in the REMS by completing and submitting the Pharmacy/Healthcare Setting Enrollment Form for Peyronie’s disease.
Before dispensing Xiaflex
  • Verify that the prescriber is certified.
Ongoing
  • Do not distribute, transfer, loan, or sell product.
  • Maintain records of current certified prescribers.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:


Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.

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