These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA.
TRUVADA ® (emtricitabine/tenofovir disoproxil fumarate) tablets, for oral use
Initial U.S. Approval: 2004
WARNINGS: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PrEP IN UNDIAGNOSED HIV-1 INFECTION
See full prescribing information for complete boxed warning.
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Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA. (5.1)
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TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection. Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued TRUVADA. Therefore, hepatic function should be monitored closely in HBV-infected patients who discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted. (5.2)
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TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use. Drug-resistant HIV-1 variants have been identified with the use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed. (5.9)
RECENT MAJOR CHANGES
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Boxed Warning |
07/2012 |
Indications and Usage
Pre-exposure Prophylaxis (1.2) |
07/2012 |
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Dosage and Administration (2) |
07/2012 |
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Contraindications (4) |
07/2012 |
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Warnings and Precautions |
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New Onset or Worsening Renal Impairment (5.3) |
07/2012 |
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Decreases in Bone Mineral Density (5.5) |
07/2012 |
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Immune Reconstitution Syndrome (5.7) |
07/2012 |
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Comprehensive Management to Reduce the Risk of Acquiring HIV-1 (5.9) |
07/2012 |
INDICATIONS AND USAGE
