PMS-Entecavir

Entecavir

Chronic HBV infection in adults w/ evidence of active viral replication & either evidence of persistent elevations in ALT or AST, or histologically active disease.

Compensated liver disease Nucleoside-treatment-naïve adult & adolescent ≥16 yr 0.5 mg once daily. Adult & adolescent ≥16 yr w/ history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations 1 mg once daily. Decompensated liver disease Adult 1 mg once daily. Renal impairment: Usual dose: CrCl ≥50 mL/min 0.5 mg once daily, 30 to <50 mL/min 0.5 mg every 48 hr, 10 to <30 mL/min 0.5 mg every 72 hr, <10 mL/min, haemodialysis or continuous ambulatory peritoneal dialysis 0.5 mg every 7 days; Lamivudine-refractory or decompensated liver disease: CrCl ≥50 mL/min 1 mg once daily, 30 to <50 mL/min 0.5 mg once daily or 1 mg every 48 hr, 10 to <30 mL/min 1 mg every 72 hr, <10 mL/min, haemodialysis or continuous ambulatory peritoneal dialysis 1 mg every 7 days.

Should be taken on an empty stomach: Take at least 2 hr before or after a meal. For Chronic HBV Infection, take w/ or w/o meal.

Hypersensitivity.

Potential severe acute exacerbations of hepatitis B upon discontinuation of therapy; monitor hepatic function closely w/ both clinical & laboratory follow-up for at least several mth upon discontinuation. Not recommended for HIV/HBV co-infected patients who are not also receiving highly active antiretroviral therapy. Potential lactic acidosis & severe hepatomegaly w/ steatosis, including fatal cases; suspend therapy if patient develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly & steatosis even in the absence of marked transaminase elevations). Patients w/ lactose intolerance. Preexisting lamivudine-resistant HBV. Higher risk of lactic acidosis in patients w/ decompensated liver disease. Carefully monitor renal function before & during treatment in liver transplant recipient who has received or is receiving an immunosuppressant that may affect renal function, eg, cyclosporine or tacrolimus. Pregnancy & lactation. Childn <16 yr. Elderly. US Hispanic population.

Exacerbations of hepatitis after discontinuation of treatment; lactic acidosis & severe hepatomegaly w/ steatosis. Headache, fatigue, dizziness & nausea.

Drugs that reduce renal function or compete for active tubular secretion may increase serum conc of either entecavir or the coadministered drug. Monitor for adverse events when coadministered w/ other drugs that are renally eliminated or are known to affect renal function.

Antivirals

J05AF10 - entecavir ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

POM