Approved Risk Evaluation and Mitigation Strategies (REMS)

Xiaflex (collagenase clostridium histolyticum)

BLA #125338

REMS last update: 10/30/2018

Goals
Summary
REMS Materials
Update history

What is the purpose of the REMS?

The goal of the XIAFLEX REMS is to mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX for Peyronie’s disease by:

Training healthcare providers in how to properly administer XIAFLEX.
Informing healthcare providers about the risks of corporal rupture (penile fracture)and other serious injuries to the penis.
Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie’s disease and that patient adherence to post-injection instructions is important for the drug’s safety and effectiveness.
Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie’s disease.
Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie’s disease and that adherence to post-injection instructions is important for the drug’s safety and effectiveness.

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

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. For a specific Medication Guide of a product in the Xiaflex REMS, see the DailyMed link(s).

Material Name	Material Name Link
Healthcare Provider Enrollment Form for Peyronie's Disease (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Healthcare_Provider_Enrollment_Form_for_Peyronies_Disease.pdf
Patient Counseling Tool - What You Need to Know About Xiaflex: A Patient Guide (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Patient_Counseling_Tool_What_You_Need_to_Know_About_Xiaflex_A_Patient_Guide.pdf
Pharmacy/Healthcare Setting Enrollment Form for Peyronie's Disease (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Pharmacy_Healthcare_Setting_Enrollment_Form_for_Peyronies_Disease.pdf
REMS Document (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_REMS_Document.pdf
REMS Full (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_REMS_Full.pdf
REMS Program Website Screenshots (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_REMS_Program_Website_Screenshots.pdf
Training Guide for Administering Xiaflex for Peyronie's Disease (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Training_Guide_for_Administering_Xiaflex_for_Peyronies_Disease.pdf
Training Video for Administering Xiaflex for Peyronie's Disease (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/rems/Xiaflex_2018_10_30_Training_Video_for_Administering_Xiaflex_for_Peyronies_Disease.pdf

What updates have been made to the REMS?

Date	Summary of change
10/30/2018	Revised to reflect minor editorial changes.
09/26/2018	Modified to revise REMS educational materials to align with safety labeling changes.
07/10/2018	Revised to reflect a change in ownership.
01/25/2017	Revised to correct a typographical error (s).
11/28/2016	Modified the REMS for the treatment of Dupuytren’s contracture to: Remove the communication plan from the REMS. Release the REMS requirements. Modified the REMS for the treatment of Peyronie’s disease to: Change to the Prescriber Material, “Training Guide for the Administration of Xiaflex for Peyronie’s Disease” Change to the Patient Counseling Tool, “What You Need to Know About XIAFLEX Treatment for Peyronie’s Disease: A Patient Guide” Align the Training Video with the Prescriber Material. Align the Xiaflex REMS Program website with the Prescriber Material. Remove information related to the communication plan.
10/20/2014	Modified the REMS for the treatment of Dupuytren’s contracture to: Include the following change to information in the dosing regimen: two concurrent injections of Xiaflex into palpable cords affecting multiple joints in the same hand in adult patients with Dupuytren’s contracture with finger extension procedure 24 to 72 hours after injection; and Include the risk of skin laceration requiring skin graft in patients treated with Xiaflex (collagenase clostridium histolyticum) in the communication plan materials (Dear Healthcare Provider Letter; Training Guide for the Administration of Xiaflex; and Xiaflex Procedure Training Video).
12/06/2013	Modified to ensure that the benefits of the drug outweigh the risk of corporal fracture (penile fracture) and other serious penile injuries by ensuring that healthcare providers who prescribe XIAFLEX (collagenase clostridium histolyticum) for Peyronie’s disease are specially certified, and that pharmacies or healthcare settings that dispense XIAFLEX (collagenase clostridium histolyticum) for Peyronie’s disease are specially certified.
02/24/2012	Modified to: Eliminate the requirement for the Medication Guide as an element of the REMS. Address the requirements in our June 1, 2011 REMS Modification Notification letter to revise some of the communication plan materials to more effectively educate prescribers about the risks when injecting Xiaflex into a cord of the proximal interphalangeal joint of the fifth finger.
02/02/2010	Approval of the REMS.

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.

Xiaflex (collagenase clostridium histolyticum) BLA #125338 REMS last update: 10/30/2018