Approved Risk Evaluation and Mitigation Strategies (REMS)
Xiaflex (collagenase clostridium histolyticum)
BLA #125338
REMS last update: 10/30/2018
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 |
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Before writing the first prescription for a patient |
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Healthcare settings and pharmacies that dispense Xiaflex
To be able to dispense Xiaflex |
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Before dispensing Xiaflex |
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Ongoing |
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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 |
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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 |
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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 |
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10/20/2014 |
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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:
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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.
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