Entecavir TEVA

Entecavir

Chronic HBV infection in adults w/ decompensated liver disease; adult & nucleoside naive paed patients 2 to <18 yr w/ compensated liver disease & evidence of active viral replication, persistently elevated serum ALT levels & histological evidence of active inflammation &/or fibrosis.

Decompensated liver disease Adult 1 mg once daily. Duration of therapy: At least 12 mth after achieving HBe seroconversion or until HBs seroconversion or loss of efficacy in HBeAg +ve adults. At least until Hbs seroconversion or w/ evidence of loss of efficacy in HBeAg -ve patients. Compensated liver disease Nucleoside-naïve adult 0.5 mg once daily. Lamivudine-refractory patients w/ evidence of viraemia while on lamivudine or presence of lamivudine resistance mutations 1 mg once daily. Paed w/ body wt at least 32.6 kg One 0.5 mg-tab daily. HBeAg +ve paed At least 12 mth after achieving undetectable HBV DNA & HBeAg seroconversion or until HBs seroconversion or loss of efficacy. HBeAg -ve paed Until HBs seroconversion or loss of efficacy. Renal impairment: Nucleoside naïve patient w/ CrCl ≥50 mL/min 0.5 mg once daily, 30-49 mL/min 0.25 mg once daily, 10-29 mL/min 0.15 mg once daily, <10 mL/min, haemodialysis or continuous ambulatory peritoneal dialysis (CAPD) 0.05 mg once daily or 0.5 mg every 5-7 days; lamivudine-refractory or decompensated liver disease w/ CrCl ≥50 mL/min 1 mg once daily, 30-49 mL/min 0.5 mg once daily, 10-29 mL/min 0.3 mg once daily, <10 mL/min, haemodialysis or CAPD 0.1 mg once daily or 0.5 mg every 72 hr.

For nucleoside naïve patients w/ compensated liver disease: May be taken with or without food.. For lamivudine-refractory patients w/ compensated liver disease & patients w/ decompensated liver disease: Should be taken on an empty stomach. Take >2 hr before & after a meal.

Hypersensitivity.

Discontinue treatment if rapidly elevating aminotransferase levels, progressive hepatomegaly or metabolic/lactic acidosis of unknown aetiology occur. Not for use in HIV/HBV co-infected patients not receiving highly active antiretroviral therapy. Not recommended for HIV infection. Child-Turcotte-Pugh (CTP) class C disease. Lactic acidosis (in the absence of hypoxaemia), w/ severe hepatomegaly & hepatic steatosis; entecavir-associated resistance. Patients w/ hepatomegaly, hepatitis or known risk factors for liver disease; co-infected w/ hepatitis C or D. Monitor virological response; hepatic function at repeat intervals w/ both clinical & lab follow-up for at least 6 mth after discontinuation of therapy; clinical & lab parameters in patients w/ decompensated liver disease. Evaluate renal function before & during therapy in liver transplant patients receiving cyclosporine or tacrolimus. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair ability to drive & use machines. Advanced liver disease or cirrhosis. Renal impairment. Women of childbearing potential should use effective contraception. Not to be used during pregnancy. Discontinue breastfeeding during treatment. Paed.

Insomnia; headache, dizziness, somnolence; vomiting, diarrhoea, nausea, dyspepsia; increased transaminases; fatigue. Neutropenia (in paed).

Increased serum conc w/ medicinal products that reduce renal function or compete for active tubular secretion.

Antivirals

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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