Baraclude Dosage

Generic name: entecavir
Dosage form: tablets, film coated; oral solution

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2.1   Timing of Administration

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

2.2   Recommended Dosage in Adults

Compensated Liver Disease

The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleoside-inhibitor-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 substitutions 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.

2.3   Recommended Dosage in Pediatric Patients

Table 1 describes the recommended dose of BARACLUDE for pediatric patients 2 years of age or older and weighing at least 10 kg. The oral solution should be used for patients with body weight up to 30 kg.

Table 1:   Dosing Schedule for Pediatric Patients
Recommended Once-Daily Dose of Oral Solution (mL)
Body Weight (kg) Treatment-Naïve
Patientsa
Lamivudine-Experienced
Patientsb

10 to 11

3

6

greater than 11 to 14

4

8

greater than 14 to 17

5

10

greater than 17 to 20

6

12

greater than 20 to 23

7

14

greater than 23 to 26

8

16

greater than 26 to 30

9

18

greater than 30

10

20

a  Children with body weight greater than 30 kg should receive 10 mL (0.5 mg) of oral solution or one 0.5 mg tablet once daily.
b  Children with body weight greater than 30 kg should receive 20 mL (1 mg) of oral solution or one 1 mg tablet once daily.

2.4   Renal Impairment

In adult 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 2. The once-daily dosing regimens are preferred.

Table 2:   Recommended Dosage of BARACLUDE in Adult 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 or greater

0.5 mg once daily

1 mg once daily

30 to less than 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 less than 30

0.15 mg once dailya
OR
0.5 mg every 72 hours

0.3 mg once dailya
OR
1 mg every 72 hours

Less than 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

Although there are insufficient data to recommend a specific dose adjustment of BARACLUDE in pediatric patients with renal impairment, a reduction in the dose or an increase in the dosing interval similar to adjustments for adults should be considered.

2.5   Hepatic Impairment

No dosage adjustment is necessary for patients with hepatic impairment.

2.6   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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