Life-Threatening (Including Fatal) Hepatotoxocity, Skin Reactions, Hematologic Toxicity, Myopathy, Lactic Acidosis and Severe Hepatomegaly, Exacerbations of Hepatitis B
Fatal and non-fatal hepatotoxicity have been reported in patients taking nevirapine, a component of lamivudine, nevirapine, and zidovudine tablets. Discontinue immediately if clinical hepatitis or transaminase elevations combined with rash or other systemic symptoms occur. Do not restart lamivudine, nevirapine, and zidovudine tablets after recovery.
Fatal and non-fatal skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions, have been reported. Discontinue immediately if severe skin reactions, hypersensitivity reactions, or any rash with systemic symptoms occur. Check transaminase levels immediately for all patients who develop a rash in the first 18 weeks of treatment. Do not restart lamivudine, nevirapine, and zidovudine tablets after recovery.
Monitoring during the first 18 weeks of therapy is essential. Extra vigilance is warranted during the first 6 weeks of therapy, which is the period of greatest risk of these events.
Hematologic toxicity including neutropenia and severe anemia have been associated with the use of zidovudine, a component of lamivudine, nevirapine, and zidovudine tablets.
Symptomatic myopathy associated with prolonged use of zidovudine.
Lactic Acidosis and Severe Hepatomegaly
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 lamivudine, nevirapine, and zidovudine tablets. Suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
Exacerbations of Hepatisis B
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 lamivudine, nevirapine, and zidovudine tablets. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis treatment.