Tenof-Em Indications/Uses

Treatment of HIV-1 Infection: Emtricitabine and tenofovir disoproxil fumarate tablet, a combination of emtricitabine and tenofovir disoproxil fumarate, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. (See Pharmacology: Pharmacodynamics: Clinical Studies under Actions and Dosage & Administration.)
The following points should be considered when initiating therapy with emtricitabine and tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection: It is not recommended that emtricitabine and tenofovir disoproxil fumarate tablet be used as a component of a triple nucleoside regimen; Emtricitabine and tenofovir disoproxil fumarate tablet should not be coadministered with ATRIPLA, COMPLERA, emtricitabine, GENVOYA, ODEFSEY, STRIBILD, tenofovir disoproxil fumarate or lamivudine-containing products (see Precautions); In treatment experienced patients, the use of emtricitabine and tenofovir disoproxil fumarate tablet should be guided by laboratory testing and treatment history (see Microbiology under Actions).
Pre-Exposure Prophylaxis: Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
When considering emtricitabine and tenofovir disoproxil fumarate tablet for pre-exposure prophylaxis the following factors may help to identify individuals at high risk: has partner(s) known to be HIV-1 infected or engages in sexual activity within a high prevalence area or social network and one or more of the following: Inconsistent or no condom use; diagnosis of sexually transmitted infections; exchange of sex for commodities (such as money, food, shelter, or drugs); use of illicit drugs or alcohol dependence; incarceration; partner(s) of unknown HIV-1 status with any of the factors listed previously.
When prescribing emtricitabine and tenofovir disoproxil fumarate tablet for pre-exposure prophylaxis, healthcare providers must: Prescribe emtricitabine and tenofovir disoproxil fumarate tablet as part of a comprehensive prevention strategy because emtricitabine and tenofovir disoproxil fumarate tablet is not always effective in preventing the acquisition of HIV-1 infection (see Precautions); counsel all uninfected individuals to strictly adhere to the recommended emtricitabine and tenofovir disoproxil fumarate tablet dosing schedule because the effectiveness of emtricitabine and tenofovir disoproxil fumarate tablet in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials (see Precautions); confirm a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablet for a PrEP indication. If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. (See Precautions.); screen for HIV-1 infection at least once every 3 months while taking emtricitabine and tenofovir disoproxil fumarate tablet for PrEP.