Baraclude
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FDA Labeling Changes
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Uses
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:
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- In adult patients, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve 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 (14.1)].
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- In pediatric patients 2 years of age and older, this indication is based on clinical trial data in nucleoside-inhibitor-treatment-naïve and in a limited number of lamivudine-experienced subjects with HBeAg-positive chronic HBV infection and compensated liver disease [see Clinical Studies (14.2)].
History
There is currently no drug history available for this drug.
Other Information
BARACLUDE® is the tradename for entecavir, a guanosine nucleoside analogue with selective activity against HBV. The chemical name for entecavir is 2-amino-1,9-dihydro-9-[(1S,3R,4S)-4-hydroxy-3-(hydroxymethyl)-2-methylenecyclopentyl]-6H-purin-6-one, monohydrate. Its molecular formula is C12H15N5O3∙H2O, which corresponds to a molecular weight of 295.3. Entecavir has the following structural formula:
Entecavir is a white to off-white powder. It is slightly soluble in water (2.4 mg/mL), and the pH of the saturated solution in water is 7.9 at 25° C ± 0.5° C.
BARACLUDE film-coated tablets are available for oral administration in strengths of 0.5 mg and 1 mg of entecavir. BARACLUDE 0.5 mg and 1 mg film-coated tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, crospovidone, povidone, and magnesium stearate. The tablet coating contains titanium dioxide, hypromellose, polyethylene glycol 400, polysorbate 80 (0.5 mg tablet only), and iron oxide red (1 mg tablet only). BARACLUDE Oral Solution is available for oral administration as a ready-to-use solution containing 0.05 mg of entecavir per milliliter. BARACLUDE Oral Solution contains the following inactive ingredients: maltitol, sodium citrate, citric acid, methylparaben, propylparaben, and orange flavor.
Sources
Baraclude Manufacturers
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E.r. Squibb & Sons, L.l.c.
![Baraclude (Entecavir) Tablet, Film Coated Baraclude (Entecavir) Solution [E.r. Squibb & Sons, L.l.c.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Baraclude | E.r. Squibb & Sons, L.l.c.
2.1 Timing of AdministrationBARACLUDE 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 DiseaseThe 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 DiseaseThe 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 PatientsTable 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
Patientsb10 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
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.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 hours0.5 mg once daily
OR
1 mg every 48 hours10 to less than 30
0.15 mg once dailya
OR
0.5 mg every 72 hours0.3 mg once dailya
OR
1 mg every 72 hoursLess than 10
Hemodialysisb or CAPD0.05 mg once dailya
OR
0.5 mg every 7 days0.1 mg once dailya
OR
1 mg every 7 daysAlthough 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 ImpairmentNo dosage adjustment is necessary for patients with hepatic impairment.
2.6 Duration of TherapyThe 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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