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Baraclude
entecavir
Black Box Warnings .
Hepatitis B Exacerbation
severe acute hepatitis exacerbations reported when D/C anti-HBV tx incl. entecavir; monitor hepatic fxn closely for at least several mo if D/C tx; resume anti-HBV tx if needed
HIV Resistance
entecavir not recommended in HIV/HBV co-infected pts not receiving HAART due to potential development of resistance to HIV nucleoside reverse transcriptase inhibitors
Lactic Acidosis/Severe Hepatomegaly with Steatosis
lactic acidosis and severe hepatomegaly w/ steatosis, incl. fatal cases, associated w/ nucleoside analog inhibitor use alone or in combination; incr. risk if female, obese, or long-term nucleoside analog tx; suspend tx if clinical or laboratory findings suggest lactic acidosis or hepatotoxicity
Adult Dosing .
Dosage forms: TAB: 0.5 mg, 1 mg; SOL: 0.05 mg per mL
hepatitis B infection, chronic
- [compensated liver dz, nucleoside-naive pts]
- Dose: 0.5 mg PO qd; Info: give 2h before or after meal
- [compensated liver dz, nucleoside-refractory pts]
- Dose: 1 mg PO qd; Info: for lamivudine-refractory or known lamivudine or telbivudine resistance substitutions; give 2h before or after meal
- [decompensated liver dz]
- Dose: 1 mg PO qd; Info: give 2h before or after meal
renal dosing
- [compensated liver dz, nucleoside-naive pts]
- CrCl 30-49: 0.25 mg qd or 0.5 mg q48h; CrCl 10-29: 0.15 mg qd or 0.5 mg q72h; CrCl <10: 0.05 mg qd or 0.5 mg qwk
- HD: 0.05 mg qd or 0.5 mg qwk, on dialysis days admin. after dialysis; no supplement; PD: 0.05 mg qd or 0.5 mg qwk; no supplement
- [compensated liver dz, nucleoside-refractory pts]
- CrCl 30-49: 0.5 mg qd or 1 mg q48h; CrCl 10-29: 0.3 mg qd or 1 mg q72h; CrCl <10: 0.1 mg qd or 1 mg qwk
- HD: 0.1 mg qd or 1 mg qwk, on dialysis days admin. after dialysis; no supplement; PD: 0.1 mg qd or 1 mg qwk; no supplement
- [decompensated liver dz]
- CrCl 30-49: 0.5 mg qd or 1 mg q48h; CrCl 10-29: 0.3 mg qd or 1 mg q72h; CrCl <10: 0.1 mg qd or 1 mg qwk
- HD: 0.1 mg qd or 1 mg qwk, on dialysis days admin. after dialysis; no supplement; PD: 0.1 mg qd or 1 mg qwk; no supplement
hepatic dosing
- [no adjustment]
Peds Dosing .
- Dosage forms: TAB: 0.5 mg, 1 mg; SOL: 0.05 mg per mL
chronic hepatitis B infection, nucleoside-naive pts
- [2 yo and older, 10-11 kg]
- Dose: 0.15 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 11.1-14 kg]
- Dose: 0.2 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 14.1-17 kg]
- Dose: 0.25 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 17.1-20 kg]
- Dose: 0.3 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 20.1-23 kg]
- Dose: 0.35 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 23.1-26 kg]
- Dose: 0.4 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 26.1-30 kg]
- Dose: 0.45 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, >30 kg]
- Dose: 0.5 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
chronic hepatitis B infection, lamivudine-refractory pts
- [2 yo and older, 10-11 kg]
- Dose: 0.3 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 11.1-14 kg]
- Dose: 0.4 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 14.1-17 kg]
- Dose: 0.5 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 17.1-20 kg]
- Dose: 0.6 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 20.1-23 kg]
- Dose: 0.7 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 23.1-26 kg]
- Dose: 0.8 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, 26.1-30 kg]
- Dose: 0.9 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
- [2 yo and older, >30 kg]
- Dose: 1 mg PO qd; Info: for pts w/ compensated liver dz; give 2h before or after meal
renal dosing
- [not defined]
- renal impairment: consider adult renal dosing for guidance
- HD/PD: consider adult renal dosing for guidance
hepatic dosing
- [no adjustment]