April 29, 2016
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Baraclude




Indications
Dosage
How Supplied

INDICATIONS

BARACLUDE® (entecavir) is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older 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:

  • In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-na´ve and lamivudine-resistant subjects with HBeAg-positive and HBeAg-negative HBV infection and compensated liver disease and a more limited number of subjects with decompensated liver disease [see Clinical Studies].
  • In pediatric patients 2 years of age and older, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-na´ve and in a limited number of lamivudine-experienced subjects with HBeAg-positive chronic HBV infection and compensated liver disease [see Clinical Studies].

DOSAGE AND ADMINISTRATION

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).

Recommended Dosage In Adults

Compensated Liver Disease

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

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

Body Weight (kg) Recommended Once-Daily Dose of Oral Solution (mL)
Treatment-Na'ive 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.

Renal Impairment

In adult 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 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)
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
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.

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.

Hepatic Impairment

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.

HOW SUPPLIED

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. Ten milliliters of the oral solution provides a 0.5 mg dose and 20 mL provides a 1 mg dose of entecavir.

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
90 tablets 0003-1611-13
1 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 0.5 mL increments up to 10 mL.

Storage

BARACLUDE Tablets should be stored in a tightly closed container at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 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°C and 30°C (59°F and 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.

Distributed by: Bristol-Myers Squibb Company Princeton, NJ 08543 USA. Revised: August 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/1/2016

Indications
Dosage
How Supplied

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