Entecavir

What it is and how it works

Mechanism of Action Entecavir is an antiviral drug against the hepatitis B virus .

Indications

Entecavir tablets are indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. Entecavir tablets are a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Dosage and administration (summary)

Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg: dosing is based on weight. Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old): 1 mg once daily. Decompensated liver disease (adults): 1 mg once daily. Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. Entecavir tablets should be administered on an empty stomach.

Contraindications

None. None.

Warnings and precautions

Severe acute exacerbations of hepatitis B virus infection after discontinuation: Monitor hepatic function closely for at least several months. (5.1, 6.1) Co-infection with HIV: Entecavir is not recommended unless the patient is also receiving HAART. Lactic acidosis and severe hepatomegaly with steatosis: If suspected, treatment should be suspended. Severe Acute Exacerbations of Hepatitis B Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir .

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Storage and supply

Entecavir tablets, USP 0.5 mg, are supplied as white to off-white, oval, film-coated, biconvex bevel edged, unscored tablet, debossed with “AN” on one side and “446” on the other side.

Source: Entecavir (Entecavir) — US FDA prescribing information, 2019-11-24, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.