Hematologic toxicity, Myopathy, Lactic acidosis and Severe Hepatomegaly with Steatosis, and Exacerbations of Hepatitis B

• Hematologic toxicity, including neutropenia and anemia, has been associated with the use of zidovudine, a component of COMBIVIR.
• Symptomatic myopathy associated with prolonged use of zidovudine.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues including lamivudine and zidovudine (components of COMBIVIR).
• Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
• Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and human immunodeficiency virus (HIV-1) and have discontinued lamivudine, a component of COMBIVIR.
• Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.