ABYTONE (Abiraterone Acetate) Tablets 250mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Abiraterone Acetate

Boleh didapati daripada:

ACCORD HEALTHCARE SDN.BHD.

INN (Nama Antarabangsa):

Abiraterone Acetate

Unit dalam pakej:

120 Tablets

Dikeluarkan oleh:

Aizant Drug Research Solutions Private Limited

Risalah maklumat

ABYTONE TABLETS
Abiraterone Acetate Tablet (250 mg)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What ABYTONE
is used for
2.
How ABYTONE
works
3.
Before you use ABYTONE
4.
How to use ABYTONE
5.
While you are using it
6.
Side effects
7.
Storage and disposal of ABYTONE
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
11.
Serial Number
WHAT ABYTONE
IS USED FOR
ABYTONE
is indicated with
prednisone or prednisolone for the
treatment of prostate cancer that has
spread to other parts of the body.
HOW ABYTONE
WORKS
ABYTONE
stops your body from
making testosterone; this can slow the
growth of prostate cancer. Research has
shown that testosterone helps to fuel the
tumor.
Reducing the production of testosterone
is important to manage your illness.
When ABYTONE is prescribed for the
early stage of disease where it is still
responding to hormone therapy, it is
used with a treatment that lowers
testosterone (androgen deprivation
therapy).
When you take this medicine your
doctor will also prescribe another
medicine called prednisone or
prednisolone. This is to lower your
chances of getting high blood pressure,
having too much water in your body
(fluid retention), or having reduced
levels of a mineral known as potassium
in your blood.
BEFORE YOU USE ABYTONE
-
_When you must not use it _
-
Do not take this medicine if you
have an allergy to:
• abiraterone acetate
• any of the other ingredients listed
at the end of this leaflet
-
_Pregnancy and lactation _
Pregnancy and lactation
ABYTONE must not be taken by
women who are pregnant or
breastfeeding or might be pregnant
since ABYTONE may affect the
baby. If you are pregnant or might
be pregnant, wear gloves if you
_ _
need to touch or handle
ABYTONE. Women, infants and
children ABYTONE is not for use
in women and children.
-
Do not take this medicine if you
have severe liver damage
-
Do not take this medicine in
combination with Ra-223 (which is
used to treat prostate cancer).
-
_Before you start use it _

Ciri produk

PACKAGE INSERT
(FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL)
1.
NAME OF THE MEDICINAL PRODUCT
ABYTONE (Abiraterone Acetate Tablets 250 mg)
2.
QUALITATIVE AND QUATITATIVE COMPOSITION
Each tablet contains Abiraterone acetate 250 mg
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
White to off-white, oval-shaped tablets debossed with A on one side
and 250
on other side.
4.
CLINICAL PARTICULARS
4.1 INDICATIONS
Abiraterone Acetate 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.
•
the treatment of mCRPC in adult men whose disease has progressed on or
after a docetaxel-based chemotherapy regimen.
Abiraterone Acetate is also indicated in combination with prednisone
or pred-
nisolone 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 (four 250 mg tablets) as a single dai-
ly 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 presnisolone_
For mCRPC, Abiraterone Acetate is used with 10 mg prednisone or
prednis-
olone daily. For mHSPC, Abiraterone Acetate 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 starting treatment,
every
two weeks for the first three months of treatment and monthly
thereafter. Blood
pressure, serum potassium and fluid retention should be monito