Risk Evaluation and Mitigation Strategies (REMS) Summary

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FDA Date: 12/8/17

Emtricitabine/tenofovir disoproxil fumarate REMS

Goals of the emtricitabine/tenofovir disoproxil fumarate REMS Program

The goals of the REMS for TRUVADA for a Pre-Exposure Prophylaxis (PrEP) Indication are:

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

• The importance of strict adherence to the recommended dosing regimen

• The importance of regular monitoring of HIV-1 serostatus to avoid continuing to take TRUVADA for a PrEP indication, if seroconversion has occurred, to reduce the risk of development of resistant HIV-1 variants

• The fact that TRUVADA 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

REMS Elements

• Elements to Assure Safe Use

REMS Summary of Terms