BlackBoxRX
 
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Emtricitabine

Lactic Acidosis, Severe Hepatomegaly

  • Steatosis, including fatal cases have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals.

Patients co-infected with HIV and Hepatitis B Virus

  • Emtricitabine is not FDA approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of this drug have not been established in patients co-infected with HBV and HIV.
  • Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued emtricitabine.
  • Hepatic function should be monitored closely both clinical and laboratory follow-up for at least several months in patients who discontinue this drug and are co-infected with HBV and HIV.
  • If appropriate, initiation of anti-hepatitis B therapy may be warranted.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

  • It is recommended that allĀ  patients with HIV be tested for the presence of chronic HBV before initiation of antiretroviral therapy.

Patient Counseling Information

Package Inserts

Emtricitabine

Additional Information

Updated January 2018