EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE

Other

Brand names: Emtricitabine and tenofovir disoproxil fumarate

Oral

Mechanism of Action

12.1 Mechanism of Action Emtricitabine and tenofovir disoproxil fumarate is a fixed-dose combination of antiviral drugs FTC and TDF [see Microbiology ( 12.4 )] .

Indications

1 INDICATIONS AND USAGE HIV-1 Treatment ( 1.1 ) Emtricitabine and tenofovir disoproxil fumarate tablet is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF)

both HIV-1 nucleoside analog reverse transcriptase inhibitors

Warnings and Precautions ( 5.2 )].

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Comprehensive management to reduce the risk of acquiring HIV-1 when emtricitabine and tenofovir disoproxil fumarate tablet is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule
2 ) • Management to reduce the risk of acquiring HIV-1 drug resistance when emtricitabine and tenofovir disoproxil fumarate tablet is used for HIV-1 PrEP: refer to full prescribing information for additional detail
4 ) • Decreases in bone mineral density (BMD): Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss
Risk for HIV-1 acquisition includes behavioral, biological, or epidemiologic factors including but not limited to condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network

Known Side Effects

1 documented side effects by frequency

Anxiety

1-10%

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Formulations

Dosage Forms

Tablet

Route

Oral