Approved Risk Evaluation and Mitigation Strategies (REMS)

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Addyi (flibanserin)
NDA #022526
REMS last update: 05/09/2018



What is the purpose of the REMS?

The goal of the Addyi REMS is to mitigate the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol by:

  1. Ensuring prescribers and pharmacists are educated about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol and the need to counsel patients about this risk.
  2. Informing patients of the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.

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 See Disclaimer page regarding links to external sites

Wholesalers that distribute Addyi must

To be able to distribute
  • Establish processes and procedures to verify that the drug is distributed only to certified pharmacies.
  • Train all relevant staff involved on the REMS program requirements.
At all times
  • Maintain records of distribution.
  • Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Inpatient pharmacies that dispense Addyi must

To be able to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review the drug’s prescribing information.
  • Have the authorized representative review the Prescriber and Pharmacy Training Program.
    | Prescriber and Pharmacy Training |
  • Have the authorized representative complete the Knowledge Assessment and submit the successfully completed knowledge assessment to the application holder.
  • Train all relevant staff involved in the dispensing of the drug on the program requirements using the Prescriber and Pharmacy Training Program.
  • Have the authorized representative enroll in the REMS by completing and submitting the Inpatient Pharmacy Enrollment Form.
Before dispensing
  • Dispense for inpatient use only.
Every time
  • A pharmacy designates a new authorized representative: have the new authorized representative re-enroll in the REMS.
At all times
  • Report any adverse events of hypotension or syncope where an interaction with alcohol cannot be ruled out to the application holder.
  • Maintain records of training.
  • Maintain records of all processes and procedures that are in place and are being followed.
  • Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.

Healthcare Providers who prescriber Addyi must

To be able to prescribe
  • Review the drug's prescribing information.
  • Review the Prescriber and Pharmacy Training Program.
    | Prescriber and Pharmacy Training |
  • Complete the Knowledge Assessment Form and submit the successfully completed knowledge assessment to the application holder.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before the first prescription
  • Counsel the patient on the increased risk of hypotension and syncope associated with the drug due to an interaction with alcohol using the Patient-Provider Agreement Form.
    | Patient-Provider Agreement Form |
  • Complete the Patient- Provider Agreement Form. Provide the portion of the form designated for patient receipt to the patient. Retain a completed form in the patient’s record.
    | Patient-Provider Agreement Form |
At all times
  • Report any adverse events of hypotension or syncope where an interaction of alcohol cannot be ruled out to the application holder.

Patients who are prescribed Addyi

Before the first prescription
Before each dispensing
  • Receive counseling from the pharmacist on not using alcohol with drug.

Outpatient pharmacies that dispense Addyi must

To be able to dispense
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Have the authorized representative review the drug’s prescribing information.
  • Have the authorized representative review the Prescriber and Pharmacy Training Program.
  • Have the authorized representative complete the Knowledge Assessment and submit the successfully completed knowledge assessment to the application holder.
  • Train all relevant staff involved in the dispensing of the drug on the program requirements using the Prescriber and Pharmacy Training Program.
  • Establish processes and procedures to verify to verify that prior to dispensing that the prescriber is certified and counsels the patient to abstain from alcohol use with the drug.
  • For a pharmacy that supports electronic communication verification with the REMS Program system: verify the pharmacy enables its pharmacy management system to support communication with the REMS Program system, using established telecommunication standards, and runs the standardized validation test transaction to validate the system enhancements.
  • Have the authorized representative enroll in the REMS by completing and submitting the appropriate enrollment form: Multiple Location Pharmacy Enrollment Form or Individual Location Pharmacy Enrollment Form.
    | Individual Location Pharmacy Enrollment Form | | Multiple Location Pharmacy Enrollment Form |
Before dispensing
  • Counsel the patient on abstaining from alcohol use with the drug.
  • For a pharmacy that supports electronic communication verification with the REMS Program system: obtain authorization to dispense by processing the prescription through the pharmacy management system.
  • For a pharmacy that does NOT support electronic telecommunication verification with the REMS Program system: obtain authorization to dispense by contacting the call center or using the REMS website.
Every time
  • A pharmacy designates a new authorized representative: have the new authorized representative re-enroll in the REMS.
At all times
  • Report any adverse events of hypotension or syncope where an interaction with alcohol cannot be ruled out to the application holder.
  • Maintain records of training.
  • Maintain records of all processes and procedures that are in place and are being followed.
  • 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. For a specific Medication Guide of a product in the Addyi REMS, see the DailyMed link(s).
Material Name Material Name Link
Individual Location Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Individual_Location_Pharmacy_Enrollment_Form.pdf
Inpatient Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Inpatient_Pharmacy_Enrollment_Form.pdf
Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Knowledge_Assessment.pdf
Multiple Locations Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Multiple_Locations_Pharmacy_Enrollment_Form.pdf
Patient-Provider Agreement Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Patient-Provider_Agreement_Form.pdf
Prescriber and Pharmacy Training (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Prescriber_and_Pharmacy_Training.pdf
Prescriber Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_Prescriber_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_REMS_Full.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2018_05_09_REMS_Website_Screenshots.pdf

What updates have been made to the REMS?

Date Summary of change
05/09/2018 Revised to make an editorial change.
06/16/2017 Modified to:

  1. Emphasize that pharmacists must counsel patients with each prescription in the Addyi REMS Prescriber and Pharmacy Training Program.
  2. Update the presentation of the Applicant's company name and trademark symbol on all REMS materials.
05/10/2016 Revised to correct a typographical error(s).
04/08/2016 Modified to:

  1. Add the prescriber's practice setting to the Prescriber Enrollment Form.
  2. Add the authorized representative's professional title to outpatient pharmacy enrollment forms.
08/18/2015 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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