These highlights do not include all the information needed to use ENTECAVIR TABLETS safely and effectively. See full prescribing information for ENTECAVIR TABLETS.
ENTECAVIR tablets, for oral use
Initial U.S. Approval: 2005
WARNING: 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)
Entecavir 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 analogue inhibitors. (5.3)
INDICATIONS AND USAGE
Entecavir is a hepatitis B virus nucleoside analogue reverse transcriptase inhibitor indicated for the treatment of chronic hepatitis B virus infection in adults and children at least 2 years of age 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-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily. (2.2)
Nucleoside-inhibitor-treatment-naïve and lamivudine-experienced pediatric patients at least 2 years of age and weighing at least 10 kg: dosing is based on weight. ( 2.3)
Lamivudine-refractory or known lamivudine or telbivudine resistance substitutions (greater than or equal to 16 years old): 1 mg once daily. (2.2)
Decompensated liver disease (adults): 1 mg once daily. ( 2.2)
Renal impairment: Dosage adjustment is recommended if creatinine clearance is less than 50 mL/min. (2.4)
Entecavir tablets should be administered on an empty stomach. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets: 0.5 mg and 1 mg (3,16)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Severe acute exacerbations of hepatitis B virus infection after discontinuation: Monitor hepatic function closely for at least several months. (5.1,6.1)
Co-infection with HIV: Entecavir is not recommended unless the patient is also receiving HAART. (5.2)
Lactic acidosis and severe hepatomegaly with steatosis: If suspected, treatment should be suspended. (5.3)
ADVERSE REACTIONS
In adults, the most common adverse reactions (≥3%, all severity grades) are headache, fatigue, dizziness, and nausea. The adverse reactions observed in pediatric patients were consistent with those observed in adults. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Epic Pharma, LLC at 1-888-374-2791 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
Liver transplant recipients: Limited data on safety and efficacy are available. ( 8.8)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 8/2023
