Chronic HBV infection in adults w/ compensated liver disease & evidence of active viral replication, persistently elevated serum ALT levels & histological evidence of active inflammation &/or fibrosis.
Dosage/Direction for Use
Nucleoside-naïve patient 0.5 mg once daily. Lamivudine-refractory patient 1 mg once daily. Patient w/ renal impairment CrCl ≥50 mL/min Nucleoside-naïve: 0.5 mg once daily. Lamivudine-refractory: 1 mg once daily; CrCl 30-49 mL/min Nucleoside-naïve: 0.5 mg every 48 hr. Lamivudine-refractory: 0.5 mg once daily; CrCl 10-29 mL/min Nucleoside-naïve: 0.5 mg every 72 hr. Lamivudine-refractory: 0.5 mg every 48 hr; CrCl <10 mL/min, CAPD or haemodialysis Nucleoside-naïve: 0.5 mg every 5-7 days. Lamivudine-refractory: 0.5 mg every 72 hr.
Administration
Nucleoside-naïve patient: May be taken with or without food.. Lamivudine-refractory patient: Should be taken on an empty stomach: Take >2 hr before or after a meal.
Contraindications
Hypersensitivity.
Special Precautions
On-treatment/post-treatment exacerbations of hepatitis. Higher rate of serious hepatic adverse events, lactic acidosis, or hepatorenal syndrome in patients w/ decompensated liver disease. Lactic acidosis & severe hepatomegaly w/ steatosis. Discontinue treatment when rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur. Patients w/ lamivudine-resistant HBV are at higher risk of developing subsequent entecavir resistance; consider combination use w/ a 2nd antiviral which does not share a cross-resistance w/ either lamivudine or entecavir. Evaluate renal function before & during therapy in liver transplant recipients receiving cyclosporine or tacrolimus. Do not use in HIV/HBV co-infected patients who are not receiving highly active antiretroviral therapy. Patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. May impair ability to drive & use machines. Patients w/ renal impairment. Women of childbearing potential should use effective contraception. Pregnancy. Breast-feeding should be discontinued during treatment.
Co-administration of entecavir w/ medicinal products that reduce renal function or compete for active tubular secretion may increase serum conc of either medicinal product.
J05AF10 - entecavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
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