Approved Risk Evaluation and Mitigation Strategies (REMS)

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Truvada (emtricitabine and tenofovir disoproxil fumarate)
NDA #21752
REMS last update: 03/10/2016

View the Truvada Prescribing Information and Medication Guide at DailyMed.
View Truvada's Regulatory Information at Drugs@FDA

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

Healthcare Providers who prescribe Truvada for the Pre-Exposure Prophylaxis (PrEP) indication:

  • Receive training provided by the sponsor.
  • Review the educational materials for prescribers, including: Safety Information Fact Sheet for Prescribers and Healthcare Provider Education Slide Deck.
  • Complete the Training Guide for Healthcare Professionals, including the knowledge assessment.
  • 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:


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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