Approved Risk Evaluation and Mitigation Strategies (REMS)

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Mifeprex (mifepristone)
NDA #020687
REMS last update: 03/29/2016



What is the purpose of the REMS?

The goal of the Mifeprex REMS is to mitigate the risk of serious complications associated with Mifeprex by:

  1. Requiring healthcare providers who prescribe Mifeprex to be certified in the Mifeprex REMS Program.
  2. Ensuring that Mifeprex is only dispensed in certain healthcare settings by or under the supervision of a certified prescriber.
  3. Informing patients about the risk of serious complications associated with Mifeprex

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.
    | 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.
    | Patient Agreement Form |
  • 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.
    | Patient Agreement Form |
  • Complete the Patient Agreement Form with the prescriber.
    | Patient Agreement Form |
  • 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.

View additional drug-specific postmarket safety information from the FDA

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 Mifeprex REMS, see the DailyMed link(s).
Material Name Material Name Link
Patient Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_Patient_Agreement_Form.pdf
Prescriber Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_Prescriber_Agreement_Form.pdf
REMS document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_document.pdf
REMS full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_REMS_full.pdf

What updates have been made to the REMS?

Date Summary of change
03/29/2016 Modified to:
  1. Make revisions to both the prescriber and patient agreement forms.
  2. Make other changes proposed in the efficacy supplement prompted additional revisions to the Mifeprex REMS materials. During review of this efficacy supplement, FDA also assessed the current REMS program to determine whether each Mifeprex REMS element remains necessary to ensure that the drug’s benefits outweigh the risks.
06/08/2011 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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