Product Dossier

ENTECAVIR-WGR

Product Dossier for ENTECAVIR-WGR (entecavir, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

ENTECAVIR-WGR contains entecavir (as monohydrate) film coated tablets in strengths of 0.5 mg or 1 mg.

Approved indications

— Treatment of chronic hepatitis B virus infection in adults 16 years or older with evidence of active liver inflammation.

Dosing overview

ENTECAVIR-WGR should be taken orally, on an empty stomach (at least 2 hours after a meal and at least 2 hours before the next meal). The recommended oral dose in adults and adolescents older than 16 years is 0.5 mg once daily. For lamivudine-refractory patients (history of hepatitis B viremia while receiving lamivudine therapy or known lamivudine resistance), the recommended dose is 1 mg once daily. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on haemodialysis or CAPD.

Key safety warnings

Therapy with ENTECAVIR-WGR is not recommended for HIV/HBV co-infected patients who are not receiving highly active antiretroviral therapy. There is a potential for the development of HIV resistance if ENTECAVIR-WGR is used to treat chronic hepatitis B infection in patients with untreated HIV infection. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination with antiretrovirals. Acute exacerbation of hepatitis has been reported in patients who have discontinued hepatitis B therapy, including therapy with ENTECAVIR-WGR. The majority of post-treatment exacerbations appear to be self-limited. However, severe exacerbations, including fatalities, may occur. Hepatic function should be monitored closely for at least several months after discontinuation. This medicinal product contains lactose monohydrate in each daily dose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Contraindications

ENTECAVIR-WGR is contraindicated in patients with previously demonstrated hypersensitivity to entecavir or any component of the product.

Regulatory history

ENTECAVIR-WGR was first listed on the ARTG on 29 May 2024 in both 0.5 mg and 1 mg film-coated tablet strengths.