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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.
Counsel the patient on the risks, including corporal rupture and other serious
penile injuries and the need to follow important post-injection instructions using
the Patient Guide.
| What You Need to Know About Xiaflex A Patient Guide |
Counsel the patient on the risks, including corporal rupture and other serious
penile injuries and the need to follow important post-injection instructions using
the Patient Guide.
| What You Need to Know About Xiaflex A Patient Guide |
Receive counseling from the prescriber on the risks, including corporal rupture
and other serious penile injuries and the need to follow important post-injection
instructions using the Patient Guide.
| What You Need to Know About Xiaflex A Patient Guide |
Before
administration
Receive counseling from the prescriber on the risks, including corporal rupture
and other serious penile injuries and the need to follow important post-injection
instructions using the Patient Guide.
| What You Need to Know About Xiaflex A Patient Guide |
Pharmacies and healthcare settings that dispense Xiaflex for Peyronie’s
disease must:
To become
certified to
dispense
and oversee implementation and compliance with the REMS Program on behalf
of the healthcare setting.
Designate an authorized representative to carry out the certification process
and oversee implementation and compliance with the REMS Program on behalf
of the healthcare setting.
Establish processes and procedures to verify that the healthcare provider
prescribing XIAFLEX for Peyronie’s disease is certified.
For healthcare settings: Establish processes and procedures to maintain a
current list of certified healthcare providers affiliated with the healthcare
setting.
Before dispensing
Verify the prescriber is certified through the processes and procedures
established as a requirement of the REMS program.
Maintain records that all processes and procedures are in place and are being
followed.
Maintain records of certified prescribers affiliated with your healthcare setting
Comply with audits carried out by Endo Pharmaceuticals, and/or designated third
party to ensure that all processes and procedures are in place and are being
followed.
Wholesalers-distributors that distribute Xiaflex must:
To be able to
distribute
Establish processes and procedures to ensure that the drug is distributed only to
certified pharmacies and healthcare settings.
Train all relevant staff involved in ensure that the drug is distributed only to
certified pharmacies and healthcare settings.
At all times
Distribute only to certified pharmacies and healthcare settings.
Maintain records of distribution.
Comply with audits carried out by Endo Pharmaceuticals, and/or designated third
party 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).
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.
What updates have been made to the REMS?
Date
Summary of change
11/02/2022
Modified to:
Convert the REMS Document to the new, standardized format
Make changes to the Patient Counseling Tool based on the results from qualitative testing studies
Improve website functionality due to a change in REMS administrator
06/09/2022
Modified to remove the mail-in option for
healthcare provider and pharmacy/healthcare setting enrollment and other minor
updates due to a REMS administrator change.
01/11/2022
Modified to update the REMS materials to reflect the safety labeling changes that were recently approved on August 19, 2021 and approved labeling regarding penile hematoma.
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.