Classes
DEA Class; Rx
Common Brand Names; Baraclude
- Hepatitis B/Hepatitis C Agents
Description
Nucleoside analog
Used for chronic hepatitis B virus infection in nucleoside-naive and lamivudine resistant-patients, and patients with decompensated hepatic disease
In HBV/HIV coinfected patients, entecavir cannot be considered an active component of a HAART regimen
Indications
Indicated for treatment of CHB with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease
Indication is based on the following
- Histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naïve and lamivudine-resistance with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease
- Virologic, biochemical, serologic, and safety data are available from a controlled study with chronic HBV infection and decompensated liver disease
- Virologic, biochemical, serologic, and safety data are available for a limited number of adults with HIV/HBV coinfection who have received prior lamivudine therapy
Contraindications
Hypersensitivity
Adverse Effects
- Fatigue (1-3%)
- Headache (2-4%)
- Dizziness
- Nausea
- Diarrhea
- Dyspepsia
- Vomiting
- Somnolence
- Insomnia
Warnings
Use caution in liver transplant recipients or renal impairment
Discontinuation of anti-hepatitis therapy may result in severe acute exacerbations of hepatitis B; closely monitor hepatic function with both clinical and laboratory follow-up for at least several months after discontinuing therapy; if appropriate, initiation of anti-hepatitis B therapy may be warranted
Pregnancy and Lactation
Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes
Not known whether drug is present in human breast milk, affects human milk production, or has effects on the breastfed infant
Maximum Dosage
1 mg/day PO.
1 mg/day PO.
16 years and older: 1 mg/day PO.
13 to 15 years and more than 30 kg: 1 mg/day PO.
13 to 15 years and 27 to 30 kg: 0.9 mg/day PO (oral solution).
13 to 15 years and 24 to 26 kg: 0.8 mg/day PO (oral solution).
2 to 12 years and more than 30 kg: 1 mg/day PO.
2 to 12 years and 27 to 30 kg: 0.9 mg/day PO (oral solution).
2 to 12 years and 24 to 26 kg: 0.8 mg/day PO (oral solution).
2 to 12 years and 21 to 23 kg: 0.7 mg/day PO (oral solution).
2 to 12 years and 18 to 20 kg: 0.6 mg/day PO (oral solution).
2 to 12 years and 15 to 17 kg: 0.5 mg/day PO (oral solution).
2 to 12 years and 12 to 14 kg: 0.4 mg/day PO (oral solution).
2 to 12 years and 10 to 11 kg: 0.3 mg/day PO (oral solution).
younger than 2 years or less than 10 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Entecavir
tablet
- 0.5mg
- 1mg
oral solution
- 0.05mg/mL
