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Freebase Commons Common /common

  • Baraclude (E.R. Squibb & Sons, L.L.C.), manufactured drug form of Entecavir, 0.05mg/mL entecavir solution, NDC 0003-1614

Freebase Commons Business /business

Freebase Commons Medicine /medicine

Section name Section URI Prominent warning Highlight text Subject manufactured drug Section LOINC code
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  • None. (4)
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  • 34070-3
  • Warnings: Severe Acute Exacerbations Of Hepatitis B, Patients Co-infected With Hiv And Hbv, And Lactic Acidosis And Hepatomegaly
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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. 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) 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) 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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  • 34066-1
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  • Most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. (6.1) 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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  • 34084-4
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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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  • 34067-9
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  • Nucleoside-treatment-naïve with compensated liver disease (≥16 years old): 0.5 mg once daily. (2.1) Lamivudine-refractory or known lamivudine or telbivudine resistance mutations (≥16 years old): 1 mg once daily. (2.1) Decompensated liver disease (adults): 1 mg once daily. (2.1) Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. (2.2) BARACLUDE should be administered on an empty stomach. (2)
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  • 34068-7
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  • Pregnancy: Pregnancy registry available. Enroll patients by calling 1-800-258-4263. (8.1) Nursing mothers: Discontinue nursing or BARACLUDE taking into consideration the importance of BARACLUDE to the mother. (8.3)
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  • 43684-0
  • false
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  • 34092-7
  • false
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  • 34089-3
  • false
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  • 42230-3
  • false
  • Tablets: 0.5 mg and 1 mg (3, 16) Oral solution: 0.05 mg/mL (3, 16)
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  • 43678-2

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