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pHepatic decompensationsome fatalreported in HIV-1/HCV co-infected patients receiving interferon and ribavirin-based regimensmonitor for treatment-associated toxicitiesdiscontinue therapy as medically appropriate and consider dose reduction or discontinuation of interferon alfaribavirinor both./ppLactic acidosis and severe hepatomegaly with steatosisincluding fatal casesreported with use of nucleoside analoguesincluding lamivudinea majority of these cases have been in womenfemale sex and obesity may be risk factors for development of lactic acidosis and severe hepatomegaly with steatosis in patients treated with antiretroviral nucleoside analoguessuspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicitywhich may include hepatomegaly and steatosis even in the absence of marked transaminase elevations./ppRememberkeep this and all other medicines out of the reach of childrennever share your medicines with othersand use this medication only for the indication prescribed./ppEpivir-HBV is indicated for the treatment of chronic hepatitis B virus infection in pediatric patients aged 2 to 17 yearssee Indications and Usage1Clinical Pharmacology12.3Clinical Studies14.2The safety and efficacy of Epivir-HBV in pediatric patients younger than 2 years have not been established./ppSevere acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapyincluding Epivir-HBVHepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapyIf appropriateinitiation of antihepatitis B therapy may be warrantedsee Warnings and Precautions5.2/p

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