Drug Detail:Baraclude (Entecavir [ en-tek-a-vir ])
Generic Name: ENTECAVIR 0.5mg
Drug Class: Nucleoside reverse transcriptase inhibitors (NRTIs)
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.
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.
| 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. |
||
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.
| 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 |
0.5 mg once daily |
|
10 to less than 30 |
0.15 mg once dailya |
0.3 mg once dailya |
|
Less than 10 |
0.05 mg once dailya |
0.1 mg once dailya |
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.
