ZYTIGA 250mg tablet

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Abiraterone Acetate

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

Abiraterone Acetate

Unit dalam pakej:

120tablet Tablets

Dikeluarkan oleh:

PATHEON INC

Risalah maklumat

ZYTIGA
®
Abiraterone Acetate (250 mg; 500 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What ZYTIGA
®
is used for
2.
How ZYTIGA
®
works
3.
Before you use ZYTIGA
®
4.
How to use ZYTIGA
®
5.
While you are using ZYTIGA
®
6.
Side effects
7.
Storage and disposal of ZYTIGA
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT ZYTIGA
®
IS USED FOR
ZYTIGA
®
is indicated with prednisone
or prednisolone for the treatment of
prostate cancer that has spread to other
parts of the body.
HOW ZYTIGA
®
WORKS
ZYTIGA
®
stops your body from making
testosterone. Research has shown that
testosterone helps to fuel the tumor.
Reducing the production of testosterone
is important to manage your illness.
BEFORE YOU USE ZYTIGA
®
-
_When you must not use it _
_Pregnancy and lactation _
ZYTIGA
®
must not be taken by
women who are pregnant or breast-
feeding or might be pregnant since
ZYTIGA
®
may affect the baby.
If you are pregnant or might be
pregnant, wear gloves if you need to
touch or handle ZYTIGA
®
250 mg
uncoated tablets.
_Women, infants and children _
ZYTIGA
®
is not for use in women and
children.
_ _
_ _
_Kidney disease _
ZYTIGA
®
may be used in patients with
kidney disease.
_Liver disease _
You should not take ZYTIGA
®
if you
have severe liver disease. Your doctor
will decide whether ZYTIGA
®
can be
used if you have mild or moderate liver
problems.
_ _
-
_Before you start to use it _
ZYTIGA
®
can make high blood
pressure or heart failure or low blood
potassium worse. Taking prednisone or
prednisolone with ZYTIGA
®
helps to
avoid worsening of these conditions. If
you have these conditions, or other
heart or blood vessel problems, discuss
them with your doctor. QT
prolongation and Torsades de Pointes
have been observed in patients who
develop hypokalemia while taking
ZYTIGA. Your blood pressure, serum
potassium and signs and symptoms of
fluid retention will be monitored
clinically at least monthly.
If you are having sex with a pregn

Ciri produk

1
1.
PRODUCT NAME
ZYTIGA
®
(abiraterone acetate) 250 mg tablets
ZYTIGA
®
(abiraterone acetate) 500 mg film-coated tablets
2. DOSAGE FORMS AND STRENGTHS
ZYTIGA tablet contains 250 mg of abiraterone acetate.
ZYTIGA film coated tablets contain 500 mg of abiraterone acetate.
3.
PHARMACEUTICAL FORM
250 MG UNCOATED TABLETS
White to off-white oval tablets, debossed with “AA250” on one
side.
500 MG FILM-COATED TABLETS
Purple, oval shaped, film coated tablets, debossed with “AA” on
one side and “500” on the other.
For excipients, see PHARMACEUTICAL INFORMATION – List of Excipients.
4.
CLINICAL INFORMATION
4.1
INDICATIONS
ZYTIGA is indicated with prednisone or prednisolone for
•
the treatment of metastatic castration resistant prostate cancer
(mCRPC) in adult men who are
asymptomatic or mildly symptomatic after failure of androgen
deprivation therapy in whom
chemotherapy is not yet clinically indicated (see section 5.1).
•
the treatment of mCRPC in adult men whose disease has progressed on or
after a docetaxel-based
chemotherapy regimen.
ZYTIGA is also indicated in combination with prednisone or
prednisolone and androgen deprivation
therapy (ADT) for the treatment of patients with newly diagnosed high
risk metastatic hormone
sensitive prostate cancer (mHSPC) who may have received up to 3 months
of prior ADT.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is 1000 mg (two 500 mg tablets or four 250 mg
tablets) as a single daily dose
that must not be taken with food (see information on the method of
administration). Taking the tablets
with food increases systemic exposure to abiraterone (see sections 4.5
and 5.2).
_Dosage of prednisone or prednisolone _
For mCRPC, ZYTIGA is used with 10 mg prednisone or prednisolone daily.
For mHSPC, ZYTIGA is used with 5 mg prednisone or prednisolone daily.
Medical
castration
with
LHRH
analogue
should
be
continued
during
treatment
in
patients not
surgically castrated.
_Recommended monitoring _
Serum transaminases should be measured prior to starti