ENTECAVIR tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ENTECAVIR ANHYDROUS (UNII: NNU2O4609D) (ENTECAVIR ANHYDROUS - UNII:NNU2O4609D)

Available from:

Solco Healthcare LLC

INN (International Name):

ENTECAVIR ANHYDROUS

Composition:

ENTECAVIR ANHYDROUS 0.5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Entecavir is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Entecavir during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Prospective pregnancy data from the APR are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. Entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the APR and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. The estimated background rate for major birth

Product summary:

Entecavir tablets, USP, are available in the following strengths: 0.5 mg film-coated White to off-white, triangular-shaped 30 tablets 43547-436-03 tablet tablet, debossed with “S” on one side 90 tablets 43547-436-09 and “064” on the other side. 500 tablets 43547-436-50 1 mg film-coated Pink, triangular-shaped tablet, 30 tablets 43547-437-03 tablet debossed with “S” on one side 90 tablets 43547-437-09 and “065” on the other side. 500 tablets 43547-437-50 Storage Entecavir tablets should be stored in a tightly closed container between 20°C and 25°C (68°F and 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep the container out of light.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ENTECAVIR- ENTECAVIR TABLET, FILM COATED
Solco Healthcare LLC
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PATIENT INFORMATION
Entecavir Tablets, USP
(en-TEK-a-vir)
Dispense with Patient Information available at:
www.solcohealthcare.com/medguide/entecavir-tablets.pdf
Read this Patient Information before you start taking entecavir
tablets and each time you get a refill. There
may be new information. This information does not take the place of
talking with your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about entecavir
tablets?
1. Your hepatitis B virus (HBV) infection may get worse if you stop
taking entecavir tablets.
This usually happens within 6 months after stopping entecavir tablets.
•
Take entecavir tablets exactly as prescribed.
•
Do not run out of entecavir tablets.
•
Do not stop entecavir tablets without talking to your healthcare
provider.
•
Your healthcare provider should monitor your health and do regular
blood tests to check your liver if
you stop taking entecavir tablets.
2. If you have or get HIV that is not being treated with medicines
while taking entecavir tablets, the HIV
virus may develop resistance to certain HIV medicines and become
harder to treat. You should get an HIV
test before you start taking entecavir tablets and anytime after that
when there is a chance you were exposed
to HIV.
Entecavir tablets can cause serious side effects including:
3. Lactic acidosis (buildup of acid in the blood). Some people who
have taken entecavir tablets or medicines
like entecavir tablets (a nucleoside analogue) have developed a
serious condition called lactic acidosis. Lactic
acidosis is a serious medical emergency that can cause death. Lactic
acidosis must be treated in the hospital.
Reports of lactic acidosis with entecavir tablets generally involved
patients who were seriously ill due to their
liver disease or other medical condition.
Call your healthcare provider right away if you get any of the
following signs or symptoms of lactic acidosis:
•
You feel

Summary of Product characteristics

ENTECAVIR- ENTECAVIR TABLET, FILM COATED
SOLCO HEALTHCARE LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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._
•
•
•
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
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
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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)
ENTECAVIR TABLETS ARE 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)
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