Entecavir STELLA 0.5 mg

Rx

Indications

Treatment of chronic hepatitis B in adults with compensated liver disease with evidence of active viral replication, persistently elevated liver enzyme values, and histologically active disease, including those resistant to lamivudine.

Dosage

Adults and adolescents ≥ 16 years of age:

Patients with chronic hepatitis B virus infection in nucleoside-treatment-naive: 0.5 mg once daily.

Patients with a history of hepatitis B viremia while receiving lamivudine or known lamivudine resistance mutations: 1 mg once daily.

Patients with renal impairment:

• ClCr ≥ 50mL/min: 0.5 mg once daily (Lamivudine-refractory: 1 mg once daily)
• ClCr 30 – < 50mL/ min: 0.25 mg once daily (Lamivudine-refractory: 0.5 mg once daily)
• ClCr 10 – < 30mL/ min: 0.15 mg once daily (Lamivudine-refractory: 0.3 mg once daily)
• ClCr < 10mL/ min (Hemodialysis (administer after hemodialysis) or continuous ambulatory peritoneal dialysis (CAPD)): 0.05 mg once daily (lamivudine-refractory: 0.1 mg once daily).

Usage

Entecavir STELLA 0.5 mg should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

Patients with previously demonstrated hypersensitivity to any component of the product.

• Headache, fatigue, dizziness, and nausea.
• Diarrhoea, dyspepsia, insomnia, somnolence, and vomiting.
• Raised liver enzyme concentrations may occur and exacerbation of hepatitis has been reported after stopping treatment with entecavir.
• Lactic acidosis, usually associated with severe hepatomegaly and steatosis.

• Hepatic function should be monitored closely follow-up for at least several months in patients who discontinue anti-hepatitis B therapy.
• Renal function must be carefully monitored both before and during treatment with entecavir in liver transplant recipients.
• Entecavir should be used during pregnancy only if clearly needed and after careful consideration of the risks and benefits. Mothers should not to breast-feed if they are taking entecavir.
• Patients should be aware of how they react to drug before driving or operating machinery.