Tenof-Em Warnings

Lactic acidosis/severe hepatomegaly with steatosis, post-treatment acute exacerbation of hepatitis B, and risk of drug resistance with use of emtricitabine and tenofovir disoproxil fumarate tablets for pre-exposure prophylaxis (PrEP) in undiagnosed early HIV-1 infection.
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate, a component of emtricitabine and tenofovir disoproxil fumarate tablets, in combination with other antiretrovirals (see Precautions).
Emtricitabine and tenofovir disoproxil fumarate is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of emtricitabine and tenofovir disoproxil fumarate tablets have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue emtricitabine and tenofovir disoproxil fumarate. If appropriate, initiation of anti-hepatitis B therapy may be warranted (see Precautions).
Emtricitabine and tenofovir disoproxil fumarate tablets used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate tablets for a PrEP indication following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate tablets for a PrEP indication if signs or symptoms of acute HIV- 1 infection are present unless negative infection status is confirmed (see Precautions).