Approved Risk Evaluation and Mitigation Strategies (REMS)

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Mifepristone
Shared System REMS
REMS last update: 04/11/2019

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Mifeprex (mifepristone) (Info at Drugs@FDA) NDA 020687 DANCO LABS LLC 04/11/2019
mifepristone (Info at Drugs@FDA) ANDA 091178 GENBIOPRO 04/11/2019

What is the purpose of the REMS?

The goal of the REMS for mifepristone is to mitigate the risk of serious complications associated with mifepristone by:
  1. Requiring healthcare providers who prescribe mifepristone to be certified in the Mifepristone REMS Program.
  2. Ensuring that mifepristone 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 mifepristone.

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 mifepristone must:

To become certified to prescribe
As a condition of certification, healthcare providers must follow the guidelines for use described below:
  • Review the Patient Agreement Form with the patient and fully explain the risks of the mifepristone treatment regimen. Answer any questions the patient may have prior to receiving mifepristone. | Patient Agreement Form |
  • Sign the Patient Agreement Form and obtain the Patient's signature on the form. | Patient Agreement Form |
  • Provide the patient with a copy of the Patient Agreement Form and Medication Guide.
  • Place the signed Patient Agreement Form in the patient's medical record. | Patient Agreement Form |
  • Record the serial number from each package of mifepristone in each patient's record.
  • Report any deaths to the Mifepristone Sponsor that provided the mifepristone, identifying the patient by a non-identifiable reference and the serial number from each package of mifepristone.

Patients who are prescribed mifepristone:

The patient must sign a Patient Agreement Form indicating that she has:
  • Received, read and been provided a copy of the Patient Agreement Form. | Patient Agreement Form |
  • Received counseling from the prescriber regarding the risk of serious complications associated with mifepristone.

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 Mifepristone REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
Patient Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_Patient_Agreement_Form.pdf
Prescriber Agreement Form for Danco Laboratories, LLC (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_Prescriber_Agreement_Form_for_Danco_Laboratories_LLC.pdf
Prescriber Agreement Form for GenBioPro, Inc. (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_Prescriber_Agreement_Form_for_GenBioPro_Inc.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2019_04_11_REMS_Full.pdf

What updates have been made to the REMS?

Date Summary of change
04/11/2019 Modified to establish a SSS REMS for the elements to assure safe use and the implementation system required for the reference listed drug (RLD) Mifeprex and ANDAs referencing Mifeprex, called the Mifepristone REMS Program.

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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