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Drug Notebook

FDA Alerts

  • Lactic acidosis and severe hepatomegaly with steatosis (including some fatalities) reported rarely in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs) alone or in conjunction with other antiretrovirals. (See Lactic Acidosis and Severe Hepatomegaly with Steatosis under Cautions.)
  • Single entity or fixed-combination preparations containing tenofovir not indicated for treatment of chronic hepatitis B virus (HBV) infection; safety and efficacy not established for treatment of HIV infection in patients coinfected with HBV.
  • Exacerbations of HBV reported following discontinuance of tenofovir. Monitor hepatic function closely using both clinical and laboratory follow-up for at least several months after tenofovir is discontinued. If appropriate, initiation of treatment for HBV infection may be warranted.

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