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Approved Risk Evaluation and Mitigation Strategies (REMS)

Addyi (flibanserin)
NDA #022526
REMS last update: 10/09/2019

What is the purpose of the REMS?

The goal of the Addyi REMS is to inform patients about the increased risk of hypotension and syncope associated with Addyi due to an interaction with alcohol.

What do participants need to know?

Healthcare providers should read the relevant Medication Guide or communication materials included in the product-specific approved REMS to learn about the risk(s). 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

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
Medication Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_10_09_Medication_Guide.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Addyi_2019_10_09_REMS_Document.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
10/09/2019 Modified to remove the elements to assure safe use (ETASU) and implementation system, and include the Medication Guide as an element of the REMS.
04/02/2019 Modified to add a digital version of the REMS Patient-Provider Agreement Form (PPAF).
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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