Baraclude Dosage

Generic name: entecavir
Dosage form: tablets, oral solution

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This dosage information does not include all the information needed to use Baraclude safely and effectively. See full prescribing information for Baraclude.

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BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).

2.1 Recommended Dosage

Compensated Liver Disease

The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleoside-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily.

The recommended dose of BARACLUDE in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance mutations rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.

Decompensated Liver Disease

The recommended dose of BARACLUDE for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.

Oral Solution

BARACLUDE (entecavir) Oral Solution contains 0.05 mg of entecavir per milliliter. Therefore, 10 mL of the oral solution provides a 0.5-mg dose and 20 mL provides a 1-mg dose of entecavir.

2.2 Renal Impairment

In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology (12.3)]. Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 1. The once-daily dosing regimens are preferred.

Table 1: Recommended Dosage of BARACLUDE in Patients with Renal Impairment
Creatinine Clearance (mL/min)	Usual Dose (0.5 mg)	Lamivudine-Refractory or Decompensated Liver Disease (1 mg)
a For doses less than 0.5 mg, BARACLUDE Oral Solution is recommended. b If administered on a hemodialysis day, administer BARACLUDE after the hemodialysis session.
≥50	0.5 mg once daily	1 mg once daily
30 to <50	0.25 mg once dailya OR 0.5 mg every 48 hours	0.5 mg once daily OR 1 mg every 48 hours
10 to <30	0.15 mg once dailya OR 0.5 mg every 72 hours	0.3 mg once dailya OR 1 mg every 72 hours
<10 Hemodialysisb or CAPD	0.05 mg once dailya OR 0.5 mg every 7 days	0.1 mg once dailya OR 1 mg every 7 days

2.3 Hepatic Impairment

No dosage adjustment is necessary for patients with hepatic impairment.

2.4 Duration of Therapy

The optimal duration of treatment with BARACLUDE for patients with chronic hepatitis B virus infection and the relationship between treatment and long-term outcomes such as cirrhosis and hepatocellular carcinoma are unknown.

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