Approved Risk Evaluation and Mitigation Strategies (REMS)

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Emtricitabine/tenofovir disoproxil fumarate
Shared System REMS
REMS last update: 07/10/2018

What medicines are included in the REMS?

Product Name Application Number Application Holder Added to REMS DailyMed Link FDA Link
Truvada (emtricitabine and tenofovir disoproxil fumarate) ( PI and MG at DailyMed , Info at Drugs@FDA ) NDA 021752 GILEAD 07/16/2012 54e82b13-a037-49ed-b4b3-030b37c0ecdd http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=021752
emtricitabine and tenofovir disoproxil fumarate ( Info at Drugs@FDA ) ANDA 090894 TEVA PHARMS USA 06/08/2017 http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=090894
emtricitabine and tenofovir disoproxil fumarate (Info at Drugs@FDA) ANDA 090513 AUROBINDO PHARMA LTD 01/26/2018
emtricitabine and tenofovir disoproxil fumarate (Info at Drugs@FDA) ANDA 206436 MYLAN 04/09/2018
emtricitabine and tenofovir disoproxil fumarate ( PI at DailyMed , Info at Drugs@FDA , Info at Drugs@FDA ) ANDA 209721 AMNEAL PHARMS CO 08/22/2018 70b3deb4-951d-4d9b-a811-be5fa05529a9

What is the purpose of the REMS?

The goals of the REMS for the emtricitabine/tenofovir disoproxil fumarate for a Pre-Exposure Prophylaxis (PrEP) Indication are:

To inform and educate prescribers and uninfected adults and adolescents at risk for acquiring HIV-1 infection about:

  1. The importance of strict adherence to the recommended dosing regimen
  2. The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take emtricitabine/tenofovir disoproxil fumarate for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants
  3. The fact that emtricitabine/tenofovir disoproxil fumarate for a PrEP indication must be considered as only part of a comprehensive prevention strategy to reduce the risk of HIV-1 infection and that other preventive measures should also be used

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

Health Care Providers who prescribe Emtricitabine/tenofovir disoproxil fumarate for a PrEP indication

Take training provided by the sponsor.
Report the completion of training to the sponsor.

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 Emtricitabine/tenofovir disoproxil fumarate REMS, see the DailyMed link on the Products tab.

Material Name Material Name Link
Agreement Form for Initiating emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Agreement_Form_for_Initiating_Emtricitabine_Tenofovir_Disoproxil_Fumarate_for_Preexposure_Prophylaxis.pdf
Checklist for Prescribers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Checklist_for_Prescribers.pdf
Healthcare Provider Education Slide Deck (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Healthcare_Provider_Education_Slide_Deck.pdf
Healthcare Provider Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Dear_Healthcare_Provider_Letter.pdf
Important Safety Information for Adolescents Who Don't Have HIV (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Important_Safety_Information_for_Adolescents_Who_Dont_Have_HIV.pdf
Important Safety Information for Adults Who Don't Have HIV (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Important_Safety_Information_for_Adults_Who_Dont_Have_HIV.pdf
Important Safety Information for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Important_Safety_Information_for_Healthcare_Providers.pdf
Professional Society REMS Letter (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Professional_Society_REMS_Letter.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_REMS_Full.pdf
REMS Program Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_REMS_Program_Website_Screenshots.pdf
Safety Information Fact Sheet for Prescribers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Safety_Information_Fact_Sheet_for_Prescribers.pdf
Training Guide for Healthcare Providers (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Emtricitabine_tenofovir_2018_07_10_Training_Guide_for_Healthcare_Providers.pdf

What updates have been made to the REMS?

Date Summary of change
07/10/2018 Revised to correct a typographical error.
05/15/2018 Modified REMS materials to reflect expansion of the PrEP indication to include the adolescent patient population based on the revisions to the indication.
12/08/2017 Modified to change the graphics for the SSS REMS educational materials, including a change in color scheme and removal of Truvada brand elements.
09/21/2017 Revised to correct a typographical error (s).
06/08/2017 Modified to establish a Single Shared System (SSS) REMS for the elements to assure safe use required for the reference listed drug (RLD) Truvada and ANDAs referencing Truvada, called the emtricitabine/tenofovir disoproxil fumarate REMS Program, which will become applicable on the date of full approval of the first ANDA referencing Truvada. The modification being approved results in a two-part REMS consisting of: (1) the requirements previously approved Truvada REMS; and (2) the new single, shared system for emtricitabine/tenofovir disoproxil fumarate products. The requirements of the previously approved Truvada REMS will remain applicable until full approval of the first ANDA, at which time, they will automatically be replaced by the requirements of the single, shared system.

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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