ARTESTO (Abiraterone Acetate Tablets USP 250mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Abiraterone Acetate

Boleh didapati daripada:

DUOPHARMA HAPI SDN. BHD.

INN (Nama Antarabangsa):

Abiraterone Acetate

Unit dalam pakej:

120 Tablets

Dikeluarkan oleh:

Natco Pharma Limited

Risalah maklumat

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_)
1
ARTESTO (ABIRATERONE ACETATE TABLETS USP 250MG)
Abiraterone Acetate Tablet (250 mg)
WHAT IS IN THE LEAFLET
1.
What ARTESTO is used for
2.
How ARTESTO works
3.
Before you use ARTESTO
4.
How to use ARTESTO
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
ARTESTO
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT ARTESTO IS USED FOR
This
medicine
is
used
with
prednisone or prednisolone for
the treatment of prostate cancer
that has spread to other parts of
the body.
HOW ARTESTO WORKS
ARTESTO contains the active
ingredient
called
abiraterone
acetate.
ARTESTO
works
by
stopping the body from making
testosterone; this can slow the
growth of prostate cancer.
When ARTESTO 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 ARTESTO
-
_When you must not take 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
Do not take this medicine if
you are a woman, especially if
pregnant. ARTESTO is for use
in male patients only.
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 to use it _
Talk
to
your
doctor
before
taking ARTESTO if you have:
•
Liver problems
•
High
blood
pressure
or
heart
failure
or
low
potassium
(low
blood
potassium
may
increase
risk
of
heart
rhythm
problems)
•
Experienced heart or blood
vessel problems.
•
An

Ciri produk

Page 1 of 13
[REVISION DATE: 1059.092.2021]
[DUOPHARMA HAPI SDN BHD]
ARTESTO (ABIRATERONE ACETATE TABLETS USP 250MG)TABLET 250MG
DESCRIPTION:
White to off-white, oval shaped tablets debossed with “NA250” on
one side and plain on other side.
COMPOSITION:
Each tablet contains 250 mg of abiraterone acetate.
Excipients with known effect: Each tablet contains 198.65 mg of
lactose and sodium.
PHARMACODYNAMICS:
Pharmacotherapeutic group: endocrine therapy, other hormone
antagonists and related agents,
ATC code: L02BX03
Mechanism of action
Abiraterone acetate converted in vivo to abiraterone, an androgen
biosynthesis inhibitor. Specifically, abiraterone selectively inhibits
the enzyme 17α-
hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in and is
required for androgen biosynthesis in testicular, adrenal and
prostatic tumour tissues.
CYP17 catalyses the conversion of pregnenolone and progesterone into
testosterone precursors, DHEA and androstenedione, respectively, by
17α-
hydroxylation and cleavage of the C17,20 bond. CYP17 inhibition also
results in increased mineralocorticoid production by the adrenals (see
Warnings &
Precautions).
Androgen-sensitive prostatic carcinoma responds to treatment that
decreases androgen levels. Androgen deprivation therapies, such as
treatment with LHRH
analogues or orchiectomy, decrease androgen production in the testes
but do not affect androgen production by the adrenals or in the
tumour. Treatment with
abiraterone acetate tablets decreases serum testosterone to
undetectable levels (using commercial assays) when given with LHRH
analogues (or
orchiectomy).
Pharmacodynamic effects
Abiraterone acetate tablets decrease serum testosterone and other
androgens to levels lower than those achieved by the use of LHRH
analogues alone or by
orchiectomy. This results from the selective inhibition of the CYP17
enzyme required for androgen biosynthesis. PSA serves as a biomarker
in patients with
prostate cancer. In a Phase 3 clinical study of patients who failed
prior chemotherapy with