INDICATIONS AND USAGE
BARACLUDE® (entecavir) is indicated for the treatment of chronic hepatitis B virus 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.
The following points should be considered when initiating therapy with BARACLUDE:
- This indication is based on histologic, virologic, biochemical, and serologic responses in nucleoside-treatment-naive and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection with compensated liver disease [see Clinical Studies ].
- Limited data are available in adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see Warnings and Precautions and Clinical Studies ].
- BARACLUDE has not been evaluated in patients with decompensated liver disease.
DOSAGE AND ADMINISTRATION
BARACLUDE should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).
The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleoside-treatment-naive 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 ± rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
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.
In subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology ]. 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 (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|
0.5 mg every 48 hours
|0.5 mg once daily|
1 mg every 48 hours
|10 to <30||0.15 mg once dailya|
0.5 mg every 72 hours
|0.3 mg once dailya|
1 mg every 72 hours
Hemodialysisb or CAPD
|0.05 mg once dailya |
0.5 mg every 7 days
|0.1 mg once dailya |
1 mg every 7 days
No dosage adjustment is necessary for patients with hepatic impairment.
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.
DOSAGE FORMS AND STRENGTHS
- BARACLUDE 0.5-mg film-coated tablets are white to off-white, triangular-shaped and debossed with “BMS” on one side and “1611” on the other side.
- BARACLUDE 1-mg film-coated tablets are pink, triangular-shaped and debossed with “BMS” on one side and “1612” on the other side.
- BARACLUDE oral solution, 0.05-mg/mL, is a ready-to-use, orange-flavored, clear, colorless to pale yellow aqueous solution.
HOW SUPPLIED/STORAGE AND HANDLING
BARACLUDE® (entecavir) Tablets and Oral Solution are available in the following strengths and configurations of plastic bottles with child-resistant closures:
| Product Strength and Dosage Form || Description || Quantity || NDC Number |
|0.5-mg film-coated tablet||White to off-white, triangular-shaped tablet, debossed with “BMS” on one side and “1611” on the other side.||30 tablets|
|1.0-mg film-coated tablet||Pink, triangular-shaped tablet, debossed with “BMS” on one side and “1612” on the other side.||30 tablets||0003-1612-12|
|0.05-mg/mL oral solution||Ready-to-use, orange-flavored, clear, colorless to pale yellow aqueous solution in a 260-mL bottle.||210 mL||0003-1614-12|
BARACLUDE Oral Solution is a ready-to-use product; dilution or mixing with water or any other solvent or liquid product is not recommended. Each bottle of the oral solution is accompanied by a dosing spoon that is calibrated in 1-mL increments up to 10 mL [see Patient Counseling Information ].
BARACLUDE Tablets should be stored in a tightly closed container at 25° C (77° F); excursions permitted between 15-30° C (59-86° F) [see USP Controlled Room Temperature].
BARACLUDE Oral Solution should be stored in the outer carton at 25° C (77° F); excursions permitted between 15-30° C (59-86° F) [see USP Controlled Room Temperature]. Protect from light. After opening, the oral solution can be used up to the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.