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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-na´ve and lamivudine-resistant adult subjects with HBeAg-positive or HBeAg-negative chronic HBV infection and compensated liver disease [see Clinical Studies].
- Virologic, biochemical, serologic, and safety data are available from a controlled study in adult subjects with chronic HBV infection and decompensated liver disease [see ADVERSE REACTIONS and Clinical Studies].
- Virologic, biochemical, serologic, and safety data are available for a limited number of adult subjects with HIV/HBV co-infection who have received prior lamivudine therapy [see WARNINGS AND PRECAUTIONS and Clinical Studies].
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).
Compensated Liver Disease
The recommended dose of BARACLUDE for chronic hepatitis B virus infection in nucleosidetreatment-na´ve 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.
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
|Creatinine Clearance (mL/min)||Usual Dose (0.5 mg)||Lamivudine-Refractory or Decompensated Liver Disease (1 mg)|
|≥ 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|
|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.
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.
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||0003-1611-12|
|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 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]. Store in the outer carton to protect from light.
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.
Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Rev December 2013
Last reviewed on RxList: 1/6/2014
This monograph has been modified to include the generic and brand name in many instances.
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