Approved Risk Evaluation and Mitigation Strategies (REMS)

Contact Us | REMS Basics | Gov Delivery Get REMS Email Alerts | Data Files

Mifeprex (mifepristone)
NDA #20687
REMS last update: 03/29/2016

View Mifeprex'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).

Healthcare Providers who prescribe and dispense Mifeprex must

To be able to prescribe
  • Review the drug’s prescribing information.
  • Complete and submit the Prescriber Agreement Form.
Before dispensing
  • Review the Patient Agreement Form with the patient and fully explain the risks of the Mifeprex treatment regimen.
  • Provide the patient with the Medication Guide.
  • Complete the Patient Agreement Form with the patient. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
  • Complete the Patient Agreement Form with the patient. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.

Patients who are prescribed Mifeprex

Before receiving
  • Review the Patient Agreement Form.
  • Complete the Patient Agreement Form with the prescriber.
  • Receive counseling from the prescriber on the risks associated with Mifeprex.

Distributors that distribute Mifeprex must

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to clinics, medical offices, and hospitals identified by certified healthcare providers.
  • Establish processes and procedures to maintain a distribution system that is secure and confidential.
  • Establish processes and procedures to maintain a system for proper storage, handling, shipping, tracking package serial numbers, proof of delivery and controlled returns of Mifeprex.
  • Train all relevant staff involved in distribution of Mifeprex on the REMS Program requirements.
At all times
  • Maintain confidential distribution records of all shipments of Mifeprex.
  • Cooperate with audits carried out by the application holder 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.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.