Entecavir

Dosing

Treatment-naïve patientsLamivudine-refractory or decompensated liver disease0.5 mg PO q24h1 mg PO q24h

Safety and efficacy in pediatric patients <2y of age have not been established

  • BW 10-11 kg: 0.15 mg (3 mL) PO q24h

  • BW 11-14 kg: 0.2 mg (4 mL) PO q24h

  • BW 14-17 kg: 0.25 mg (5 mL) PO q24h

  • BW 17-20 kg: 0.3 mg (6 mL) PO q24h

  • BW 20-23 kg: 0.35 mg (7 mL) PO q24h

  • BW 23-26 kg: 0.4 mg (8 mL) PO q24h

  • BW 26-30 kg: 0.45 mg (9 mL) PO q24h

  • BW >30 kg: 0.5 mg (10 mL) PO q24h

국내허가사항에서는 라미부딘 저항성 소아 용량에 대한 언급 없음- Age 2-15y, BW 10-11 kg: 0.3 mg (6 mL) PO q24h

  • Age 2-15y, BW 11-14 kg: 0.4 mg (8 mL) PO q24h

  • Age 2-15y, BW 14-17 kg: 0.5 mg (10 mL) PO q24h

  • Age 2-15y, BW 17-20 kg: 0.6 mg (12 mL) PO q24h

  • Age 2-15y, BW 20-23 kg: 0.7 mg (14 mL) PO q24h

  • Age 2-15y, BW 23-26 kg: 0.8 mg (16 mL) PO q24h

  • Age 2-15y, BW 26-30 kg: 0.9 mg (18 mL) PO q24h

  • Age 2-15y, BW >30 kg: 1 mg (20 mL) PO q24h

No dose adjustment

CrCl 30 to <50CrCl 10 to <30CrCl <10HD0.25 mg PO q24h OR 0.5 mg PO q48h0.15 mg PO q24h OR 0.5 mg PO q72h0.05 mg PO q24h OR 0.5 mg PO q7d0.05 mg PO q24h OR 0.5 mg PO q7d (dose after hemodialysis on dialysis days)

CrCl 30 to <50CrCl 10 to <30CrCl <10HD0.5 mg PO q24h OR 1 mg PO q48h0.3 mg PO q24h OR 1 mg PO q72h0.1 mg PO q24h OR 1 mg PO q7d0.1 mg PO q24h OR 1 mg PO q7d (dose after hemodialysis on dialysis days)

General Information

Active type B viral hepatitis, chronic.

Black Box Warning: Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted. Entecavir is not recommended in patients co-infected with HIV and HBV who are not also receiving highly active antiretroviral therapy (HAART) because of the potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors.

Monitor AST/ALT, HBV envelope antigen, HBV surface antigen, and HBV DNA levels every 3 months for first year of therapy and annually thereafter during treatment.

HIV antibody testing should be offered to all patients.

Monitor hepatic function for several months after discontinuing therapy.

Monitor renal function at baseline and during therapy, especially in the elderly and in liver transplant patients on immunosuppressants.

Monitor urinalysis and serum phosphate prior to therapy and at least annually during therapy.

Common

  • Nausea

  • Fatigue

  • Headache

  • Dizziness

Severe

  • Lactic acidosis

  • Hepatomegaly (with steatosis)

  • Recurrent hepatitis

No significant interactions

Antimicrobial class: Antiviral agent, Guanosine nucleoside analog

Pregnancy category: C

Average serum half life: 128-149 hours

Precautions:

  • Dose adjustment recommended in patients with renal impairment (CrCl <50 mL/min).

  • Suspend treatment if signs or symptoms of lactic acidosis or hepatotoxicity occur.

  • Use caution in liver transplant recipients, with past or current use of an immunosuppressant which may affect renal function (e.g. cyclosporine, tacrolimus); renal function monitoring recommended.

  • Entecavir is not recommended in patients co-infected with HIV/HBV who are not receiving concurrent HIV treatment

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