| TAH Drug Code | OBAR |
|---|---|
| Indications | Treatment of chronic active type B viral hepatitis or reactivation of hepatitis B viral hepatitis in adults and children over 2 years of age. |
| Dosing | Administer on an empty stomach (2 hours before or after a meal). Adults and adolescents > 16 years: nucleoside-treatment naive, compensated liver disease: 0.5 mg once daily; decompensated liver disease: 1 mg once daily. Children and adolescents 2 to <16 years: 10 to 11 kg: 0.15 mg oral solution once daily >11 to 14 kg: 0.2 mg oral solution once daily >14 to 17 kg: 0.25 mg oral solution once daily >17 to 20 kg: 0.3 mg oral solution once daily >20 to 23 kg: 0.35 mg oral solution once daily >23 to 26 kg: 0.4 mg oral solution once daily >26 to 30 kg: 0.45 mg oral solution once daily >30 kg: 0.5 mg oral solution or tablet once daily |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment required |
| Contraindications | Hypersensitivity to entecavir or any component of the formulation. |
| Adverse Effects | Common: Nausea (Adult, <1%; Pediatric, >1%), Dizziness (<1%), Headache (2-4%), Fatigue (1-3%) Serious: Lactic acidosis, Hepatomegaly (Severe), With steatosis, Recurrent hepatitis |
| Pregnancy | Compatible – Maternal Benefit >> Embryo-Fetal Risk |
| Lactation | No (Limited) Human Data - Probably Compatible |
| More Info | UpToDate |
| TAH Drug Code | OBAR1 |
|---|---|
| Indications | Treatment of chronic active type B viral hepatitis or reactivation of hepatitis B viral hepatitis in adults and children over 2 years of age. |
| Dosing | Administer on an empty stomach (2 hours before or after a meal). Adults and adolescents > 16 years: nucleoside-treatment naive, compensated liver disease: 0.5 mg once daily; decompensated liver disease: 1 mg once daily. Children and adolescents 2 to <16 years: 10 to 11 kg: 0.15 mg oral solution once daily >11 to 14 kg: 0.2 mg oral solution once daily >14 to 17 kg: 0.25 mg oral solution once daily >17 to 20 kg: 0.3 mg oral solution once daily >20 to 23 kg: 0.35 mg oral solution once daily >23 to 26 kg: 0.4 mg oral solution once daily >26 to 30 kg: 0.45 mg oral solution once daily >30 kg: 0.5 mg oral solution or tablet once daily |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment required |
| Contraindications | Hypersensitivity to entecavir or any component of the formulation. |
| Adverse Effects | Common: Nausea (Adult, <1%; Pediatric, >1%), Dizziness (<1%), Headache (2-4%), Fatigue (1-3%) Serious: Lactic acidosis, Hepatomegaly (Severe), With steatosis, Recurrent hepatitis |
| Pregnancy | Compatible – Maternal Benefit >> Embryo-Fetal Risk |
| Lactation | No (Limited) Human Data - Probably Compatible |
| More Info | UpToDate |