Generic Name and Formulations:
Entecavir 0.5mg, 1mg; tabs.

Company:
Bristol-Myers Squibb
Indications for BARACLUDE:
Chronic hepatitis B virus (HBV) infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

Adult:
≥16yrs: Take on empty stomach. Compensated liver disease: nucleoside-naive: 0.5mg once daily; lamivudine-refractory or known lamivudine or telbivudine resistance mutations: 1mg once daily. Decompensated liver disease: 1mg once daily. Renal impairment (nucleoside-naive): CrCl 30–49mL/min: 0.25mg once daily or 0.5mg every 48 hours; CrCl 10–29mL/min: 0.15mg once daily or 0.5mg every 72 hours; CrCl <10mL/min or on hemodialysis: 0.05mg once daily or 0.5mg every 7 days; (lamivudine-refractory or decompensated liver disease): CrCl 30–49mL/min: 0.5mg once daily or 1mg every 48 hours; CrCl 10–29mL/min: 0.3mg once daily or 1mg every 72 hours; CrCl <10mL/min or on hemodialysis: 0.1mg once daily or 1mg every 7 days. For doses <0.5mg: use oral soln. If on hemodialysis day, give after session.

Children:
<16yrs: not recommended.

Warnings/Precautions:
HIV/HBV co-infected patients not receiving highly active antiretroviral therapy (HAART): not recommended. HIV antibody testing recommended before starting therapy. Monitor hepatic function during and for several months after ending therapy (risk of hepatitis B reactivation). Renal impairment (see Dose). Liver transplant. Reevaulate periodically. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
May potentiate or be potentiated by drugs that reduce renal function or compete for active tubular secretion. May increase resistance to HIV drugs in HIV patients not on HAART.

See Also:
BARACLUDE ORAL SOLUTION

Pharmacological Class:
Nucleoside analogue (HBV polymerase inhibitor).

Adverse Reactions:
Headache, fatigue, dizziness, GI upset; rare: lactic acidosis, severe hepatomegaly with steatosis (may be fatal), post-treatment severe, acute exacerbation of hepatitis.

Note:
Register pregnant patients exposed to entecavir by calling (800) 258-4263.

How Supplied:
Tabs 0.5mg—30, 90; 1mg—30; Soln—210mL (w. dosing spoon)