Risk Evaluation and Mitigation Strategy (REMS)
FDA REQUIRED REMS SAFETY INFORMATION

This website is intended for US Healthcare Professionals
Addyi REMS Support Center 1-844-233-9415

Pharmacy Training, Enrollment, and Certification (3 Easy Steps)


The Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) to ensure the benefits of Addyi® (flibanserin) outweigh the increased risk of hypotension and syncope due to an interaction with alcohol.

Prescribers and Pharmacies must be certified in the Addyi REMS Program to prescribe and dispense Addyi. For pharmacies to successfully become certified they must complete the following 3 easy steps*:

  1. Read the Addyi REMS Program Prescriber and Pharmacy Training and the Prescribing Information for Addyi. The Addyi REMS Program Prescriber and Pharmacy Training Program and Prescribing Information are available for download from this website (www.AddyiREMS.com) or they can be requested by calling the Addyi REMS Program Support Center (1-844-233-9415). You can also launch the Addyi REMS Program Prescriber and Pharmacy Training** (including the Knowledge Assessment) and enrollment process by clicking the appropriate button at the bottom of this webpage. (See Option 1: Online below for a description of the different pharmacies)
  2. Review your knowledge by answering the questions contained within the Addyi REMS Program Knowledge Assessment.
  3. Enroll in the Addyi REMS Program by completing the appropriate pharmacy enrollment process. Enrollment can be completed in 2 ways, online or fax.

* For online enrollment first sign-up by creating an account and providing all requested contact information.

Option 1: Online

Click on the appropriate button below to complete the Addyi REMS Program Prescriber and Pharmacy Training, knowledge assessment and enrollment online. Choose the button that best meets your needs.

Individual Location Outpatient Pharmacy Training Program, Certification and Enrollment

This is for individual or independent outpatient pharmacies to become certified to dispense Addyi. Clicking on this button will take the authorized representative through the entire training, enrollment and certification process.

Multiple Locations Outpatient Pharmacy Training Program, Certification and Enrollment

This is for outpatient pharmacies with multiple locations (e.g., chains). A pharmacy headquarters must complete this process before individual outlets can be certified to dispense Addyi. Clicking this button will take the authorized representative through the entire training, enrollment and certification process.

Inpatient Pharmacy Training Program, Certification and Enrollment

This is for facilities with inpatient pharmacies to become certified to dispense Addyi. Clicking on this button will take the authorized representative through the entire training, enrollment and certification process.

Pharmacy Staff Training Program for all pharmacy staff at Addyi REMS Program Certified Pharmacies.

Clicking on this button will take pharmacy staff through the appropriate training should they wish to take the Addyi REMS Program training online. After completion, pharmacy staff will be able to print a Certificate of Completion which an authorized representative can use as documentation of the training requirements of the Addyi REMS Program.

Option 2: Fax

Complete the appropriate enrollment form located on the right side of this page located under the heading Materials for Pharmacies and the Knowledge Assessment. Please fax all pages of the completed enrollment form and Knowledge Assessment to the Addyi REMS Program Support Center (1-844-694-3373) or scan and e-mail to AddyiREMSEnroll@AddyiREMS.com. You may also call the Addyi REMS Program Support Center (1-844-233-9415) to request the appropriate materials be sent to you.

** Note the training program is also available to pharmacy staff to meet the training requirements of the Addyi REMS Program.

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