Lactic Acidosis and Hepatomegaly, Exacerbations of Hepatitis B, Dosing Formulation
Lactic Acidosis and Hepatomegaly
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including lamivudine and zidovudine. Discontinue if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occur.
Exacerbations of Hepatitis B
- Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV and have discontinued lamivudine.
- Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue lamivudine and are co-infected with HIV and HBV.
- If appropriate, initiation of anti-hepatitis B therapy may be warranted.
- Lamivudine tablets and oral solution are used to treat HIV infection contain higher dose of lamivudine than either Epivir-HBV, which is used to treat chronic hepatitis B infection. HIV patients should receive only Epivir formulations.
Emergence of Resistance-Associated HBV Substitutions
- Progression of hepatitis B, including death, has been reported in some subjects with YMDD-mutant HBV, includiing subjects from the liver transplant setting and from other clinical trials. In order to reduce the risk of resistance in patients receiving monotherapy with EPIVAR-HBV, a switch to an alternative regimen should be considered if serum HBV DNA renauns detectable after 24 weeks of treatment. Optimal therapy should be guided by resistance testing.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Patients with prodromal symptoms of hepatitis should seek medical attention immediately and promptly discontinue drug.
- Obesity and prolonged nucleoside exposure may be risk factors for lactic acidosis and severe hepatomegaly. Therapy should be suspended in patients who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicty.
Patient Counseling Information