BARACLUDE TABLET 0.5mg

Země: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktivní složka:

ENTECAVIR

Dostupné s:

BRISTOL-MYERS SQUIBB (SINGAPORE) PTE. LTD.

ATC kód:

J05AF10

Dávkování:

0.5 mg

Léková forma:

TABLET, FILM COATED

Složení:

ENTECAVIR 0.5 mg

Podání:

ORAL

Druh předpisu:

Prescription Only

Výrobce:

AstraZeneca Pharmaceuticals LP

Stav Autorizace:

ACTIVE

Datum autorizace:

2006-01-16

Informace pro uživatele

1
BRISTOL-MYERS SQUIBB
BARACLUDE
®
(ENTECAVIR)
Baraclude
®
(entecavir) Tablets
Baraclude
®
(entecavir) Oral Solution
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-
INFECTED WITH HIV AND HBV, AND LACTIC ACIDOSIS AND HEPATOMEGALY
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 WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT
LEAST SEVERAL MONTHS IN
PATIENTS WHO DISCONTINUE ANTI-HEPATITIS B THERAPY. IF APPROPRIATE,
INITIATION OF ANTI-HEPATITIS
B THERAPY MAY BE WARRANTED [SEE _WARNINGS AND PRECAUTIONS (4.1)_].
LIMITED CLINICAL EXPERIENCE SUGGESTS THERE IS A POTENTIAL FOR THE
DEVELOPMENT OF RESISTANCE TO
HIV
(HUMAN
IMMUNODEFICIENCY
VIRUS)
NUCLEOSIDE
REVERSE
TRANSCRIPTASE
INHIBITORS
IF
BARACLUDE IS USED TO TREAT CHRONIC HEPATITIS B VIRUS (HBV) INFECTION
IN PATIENTS WITH
HIV INFECTION THAT IS NOT BEING TREATED. THERAPY WITH BARACLUDE IS NOT
RECOMMENDED
FOR HIV/HBV CO-INFECTED PATIENTS WHO ARE NOT ALSO RECEIVING HIGHLY
ACTIVE ANTIRETROVIRAL
THERAPY (HAART) [SEE _WARNINGS AND PRECAUTIONS (4.2)_].
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN
REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION
WITH ANTIRETROVIRALS
[SEE _WARNINGS AND PRECAUTIONS (4.3)_].
1
INDICATIONS AND USAGE
BARACLUDE

(entecavir) is 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.
The following points should be considered when initiating therapy with
BARACLUDE:
This indication is based on histologic, virologic, biochemical, and
serologic responses in
nucleoside-treatment-naïve and lamivudine-resistant adult subjects
with HBeAg-positive or
2
HBeAg-negative chronic HBV infection with compensated liver disease
[see
_Clinical Studies _
_(12)_
].
•

Charakteristika produktu

1
BARACLUDE
®
(ENTECAVIR)
Baraclude
®
(entecavir) Tablets
Baraclude
®
(entecavir) Oral Solution
WARNING: SEVERE ACUTE EXACERBATIONS OF HEPATITIS B, PATIENTS CO-
INFECTED WITH HIV AND HBV, AND LACTIC ACIDOSIS AND HEPATOMEGALY
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 WITH BOTH CLINICAL AND LABORATORY FOLLOW-UP FOR AT
LEAST SEVERAL MONTHS IN
PATIENTS WHO DISCONTINUE ANTI-HEPATITIS B THERAPY. IF APPROPRIATE,
INITIATION OF ANTI-HEPATITIS
B THERAPY MAY BE WARRANTED [SEE _WARNINGS AND PRECAUTIONS (4.1)_].
LIMITED CLINICAL EXPERIENCE SUGGESTS THERE IS A POTENTIAL FOR THE
DEVELOPMENT OF RESISTANCE TO
HIV
(HUMAN
IMMUNODEFICIENCY
VIRUS)
NUCLEOSIDE
REVERSE
TRANSCRIPTASE
INHIBITORS
IF
BARACLUDE IS USED TO TREAT CHRONIC HEPATITIS B VIRUS (HBV) INFECTION
IN PATIENTS WITH
HIV INFECTION THAT IS NOT BEING TREATED. THERAPY WITH BARACLUDE IS NOT
RECOMMENDED
FOR HIV/HBV CO-INFECTED PATIENTS WHO ARE NOT ALSO RECEIVING HIGHLY
ACTIVE ANTIRETROVIRAL
THERAPY (HAART) [SEE _WARNINGS AND PRECAUTIONS (4.2)_].
LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS, INCLUDING
FATAL CASES, HAVE BEEN
REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES ALONE OR IN COMBINATION
WITH ANTIRETROVIRALS
[SEE _WARNINGS AND PRECAUTIONS (4.3)_].
1
INDICATIONS AND USAGE
BARACLUDE

(entecavir) is 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.
The following points should be considered when initiating therapy with
BARACLUDE:
This indication is based on histologic, virologic, biochemical, and
serologic responses in
nucleoside-treatment-naïve and lamivudine-resistant adult subjects
with HBeAg-positive or
HBeAg-negative chronic HBV infection with compensated liver disease
[see
_Clinical Studies _
_(12)_
].
2

Virologic, biochemic