Baraclude® (entecavir) Tablets
Baraclude® (entecavir) Oral Solution
|
HIGHLIGHTS OF PRESCRIBING INFORMATION |
|
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 |
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)
|
|
INDICATIONS AND USAGE
|
|
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)
|
|
DOSAGE AND ADMINISTRATION
|
-
Nucleoside-treatment-naive (≥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)
-
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)
|
|
DOSAGE FORMS AND STRENGTHS
|
-
Tablets: 0.5 mg and 1 mg (3, 16)
-
Oral so
|
|
|
