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 all patients with HIV be tested for the presence of chronic HBV before initiation of antiretroviral therapy.
Patient Counseling Information
Updated January 2018