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) Tablets
BARACLUDE
®
(entecavir) Oral Solution
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)
---------------------------RECENT MAJOR CHANGES---------------------------
Indications and Usage (1) 10/2010
Dosage and Administration
Recommended Dosage (2.1) 10/2010
---------------------------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-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)
----------------------DOSAGE FORMS AND STRENGTHS---------------------
• Tablets: 0.5 mg and 1 mg (3, 16)
• Oral solution: 0.05 mg/mL (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: BARACLUDE 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------------------------------
• 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
------------------------USE IN SPECIFIC POPULATIONS-----------------------
• 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)
See 17 for PATIENT COUNSELING INFORMATION and FDA-
approved patient labeling
Revised: 12/2010
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNINGS: SEVERE ACUTE EXACERBATIONS OF HEPATITIS
B, PATIENTS CO-INFECTED WITH HIV AND HBV, AND
LACTIC ACIDOSIS AND HE
P
ATOMEGALY
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRA IONT
2.1 Recommended Dosage
2.2 Renal Impairment
2.3 Hepatic Impairment
2.4 Duration of Therapy
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Severe Acute Exacerbations of Hepatitis B
5.2 Patients Co-infected with HIV and HBV
5.3 Lactic Acidosis and Severe Hepatomegaly with Steatosis
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delive yr
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Use in Racial/Ethnic Groups
8.7 Renal Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Outcomes at 48 Weeks
14.2 Outcomes beyond 48 Weeks
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Information about Treatment
17.2 Post-treatment Exacerbation of Hepatitis
17.3 HIV/HBV Co-infection
*Sections or subsections omitted from the full prescribing information
are not listed
Reference ID: 2883958
1