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Patients should be monitored regularly during treatment by a physician experienced in the management of chronic hepatitis BDuring treatmentcombinations of events such as return of persistently elevated ALTincreasing levels of HBV DNA over time after an initial decline below assay limitprogression of clinical signs or symptoms of hepatic diseaseand/or worsening of hepatic necroinflammatory findings may be considered as potentially reflecting loss of therapeutic responseSuch observations should be taken into consideration when determining the advisability of continuing therapy with Epivir-HBV.

Epivir-HBV is not FDA approved for treatment of HIV-1 infectionlamivudine dosage in EPIVIR-HBV is subtherapeutic and monotherapy is inappropriate for the treatment of HIV-1 infection and the safety and efficacy of this drug have not been established in patients co-infected with HBV and HIVsevere acute exacerbations of hepatitis B reported in patients who have discontinued anti-hepatitis B therapyincluding HBV formulationhepatic 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 anti-hepatitis B therapy may be warranted.

There is no information available regarding the effects of the drug on the breastfed infant or on milk production.

Pharmacokinetic parameters of lamivudine are not altered by diminishing hepatic functionthereforeno dosage adjustment is required with impaired hepatic functionSafety and efficacy have not been established in patients with decompensated hepatic diseaseTreatment should be discontinued in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

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