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HIGHLIGHTS OF PRESCRIBING INFORMATION |
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These highlights do not include all the information needed to use BARACLUDE safely and effectively. See full prescribing information for BARACLUDE. |
BARACLUDE (entecavir) tablet, film coated for oral use
BARACLUDE (entecavir) solution for oral use
Initial U.S. Approval: 2005
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WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-INFECTED WITH HIV AND HBV, and LACTIC ACIDOSIS AND HEPATOMEGALY
See full prescribing information for complete boxed warning.
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Severe acute exacerbations of hepatitis B have been reported in patients who have discontinued anti-hepatitis B therapy, including entecavir. Hepatic function should be monitored closely for at least several months after discontinuation. Initiation of anti-hepatitis B therapy may be warranted. (5.1)
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BARACLUDE is not recommended for patients co-infected with human immunodeficiency virus (HIV) and hepatitis B virus (HBV) who are not also receiving highly active antiretroviral therapy (HAART), because of the potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors. (5.2)
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Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues. (5.3)
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INDICATIONS AND USAGE
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BARACLUDE is a nucleoside analogue 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. (1)
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DOSAGE AND ADMINISTRATION
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Nucleoside-treatment-naive (≥16 years old): 0.5 mg once daily. (2.1)
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Lamivudine-refractory or known lamivudine or telbivudine resistance mutations (≥16 years old): 1 mg once daily. (2.1)
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Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. (2.2)
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BARACLUDE should be administered on an empty stomach. (2)
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DOSAGE FORMS AND STRENGTHS
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Tablets: 0.5 mg and 1 mg (3, 16)
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Oral solution: 0.05 mg/mL (3, 16)
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Severe acute exacerbations of hepatitis B virus infection after discontinuation: Monitor hepatic function closely for at least several months. (5.1, 6.1)
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Co-infection with HIV: BARACLUDE is not recommended unless the patient is also receiving HAART. (5.2)
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Lactic acidosis and severe hepatomegaly with steatosis: If suspected, treatment should be suspended. (5.3)
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ADVERSE REACTIONS
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Most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. (6.1)
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To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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USE IN SPECIFIC POPULATIONS
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Pregnancy: Pregnancy registry available. Enroll patients by calling 1-800-258-4263. (8.1)
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Nursing mothers: Discontinue nursing or BARACLUDE taking into consideration the importance of BARACLUDE to the mother. (8.3)
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See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling |
Revised: 01/2009 |
