Entecavir

Antiviral, Systemic · Anti-cytomegalovirus agent

Indications

Treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated ALT levels and histological evidence of active liver inflammation and fibrosis.

Dosage

Adults: Nucleoside naive patients, 0.5 mg once daily. Lamivudine-refractory patients, 1 mg once daily at least 2 hr before or after a meal. Children: Not recommended.

Adverse Effects

Headache, fatigue, dizziness, nausea, insomnia, raised ALT, exacerbations of hepatitis, GI upset, somnolence.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Risk cannot be ruled out. Lactation: Contraindicated or not recommended. Precautions: Renal impairment. Monitor patients regularly for hepatitis B, biochemical, virological and serological markers to determine treatment duration. Cirrhosis; monitor closely for hepatic decompensation. Monitor patients closely for several months after stopping therapy for acute exacerbations of hepatitis. Patients (particularly obese women) with hepatomegaly, hepatitis, other risk factors of liver disease; risk of lactic acidosis, sometimes fatal. Co-infection with hepatitis C or D or HIV. Elderly.

Interactions

Drugs that reduce renal function or compete for active tubular secretion. Cyclosporin, tacrolimus.

Advice to Patient

0.5 mg tab: Take with or without meals. 1 mg tab: Take 2 hours before or after a meal. Take missed dose as soon as you remember, unless it is time for the next dose. Do not take double dose. Do not mix oral solution with water or any other liquid and use dosing spoon provided by the manufacturer for accurate dosage. Contact prescriber if there is weakness, tiredness, unusual muscle pain, difficulty in breathing, nausea, vomiting with stomach pain, chills, dizziness, light-headedness, fast or irregular heartbeat, yellowing of skin or eyes, dark coloured urine, pale stools, loss of appetite, lower abdominal pain.

Pharmacokinetics

Note: The pharmacokinetics of paediatric patients =2 yrs are similar to adult values. Absorption: Delayed with food; Cmax reduced 44% to 46%, AUC reduced 18%-20%. Metabolism: Hepatic. Bioavailability: Tab and oral soln are bioequivalent. Half-life elimination: Terminal: Approx. 5-6 days. Accumulation: Approx. 24 hrs. Time to peak, plasma: 0.5-1.5 hrs. Excretion: Urine (60%-73%).

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.