Trexa Tablet 250mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Gefitinib

Boleh didapati daripada:

DUOPHARMA HAPI SDN. BHD.

INN (Nama Antarabangsa):

Gefitinib

Unit dalam pakej:

30 Tablets; 30 Tablets

Dikeluarkan oleh:

Natco Pharma Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
TREXA TABLET 250MG
Gefitinib (250mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What TREXA is used for
2.
How TREXA works
3.
Before you use TREXA
4.
How to use TREXA
5.
While you are using TREXA
6.
Side effects
7.
Storage and disposal of TREXA
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT TREXA IS USED FOR
TREXA is used to treat advanced
non-small cell lung cancer, which is
a type of lung cancer.
HOW TREXA WORKS
TREXA
contains
the
active
substance gefitinib which blocks a
protein
called
‘epidermal
growth
factor
receptor’
(EGFR).
This
protein is involved in the growth
and spread of cancer cells.
BEFORE YOU USE TREXA
_-_
_ _
_When you must not use it _
•
Do not take TREXA if you
are allergic to gefitinib or
any
of
the
other
ingredients
of
TREXA,
listed at the end of this
leaflet.
•
TREXA
is
not
recommended for use in
children or adolescents.
_-_
_ _
_Before you start to use it _
•
Tell
your
doctor
if
you
have or have had any other
lung diseases, other than
your lung cancer. Some of
them may worsen during
treatment with TREXA.
•
Tell your doctor if you are
pregnant
or
trying
to
become
pregnant.
You
should
avoid
becoming
pregnant during treatment
with TREXA.
•
Tell your doctor if you are
breast-feeding.
For
the
safety of your baby, you
should discontinue breast-
feeding
during
treatment
with TREXA.
_-_
_ _
_Taking other medicines _
Please inform your doctor if you
are taking or have taken any
medicines (including medicines
taken
some
time
ago),
even
those
not
prescribed.
Your
doctor especially needs to know
if
you
are
taking
any
of
the
following medicines:
•
Phenytoin
or
carbamazepine
(for
epilepsy),
•
Rifampicin
(for
tuberculosis),
•
Barbiturates (for sleeping
problems),
•
itraconazole
(for
fungal
infections),
•
Proton-pump
inhibitors,
H
2
-antagonists
and
antacids
(for
ulcers,
indigestion, heartburn and
to
reduce
acids
in
the
stomach).
These
medicines
may
affect
the way TREXA works.
•
if
you
tak

Ciri produk

Page 1 of 3
[REVISION DATE: 07.03.2022]
[DUOPHARMA HAPI SDN BHD]
TREXA TABLETS 250MG
DESCRIPTION:
Film-coated tablets. Tablets are brown coloured, round shaped film
coated tablets debossed with “N” on one side and “250” on the
other.
COMPOSITION:
Each film-coated tablet contains 250 mg of Gefitinib
.
PHARMACODYNAMICS:
Gefitinib belongs to drug class antineoplastic agents or protein
kinase inhibitors. The epidermal growth factor (EGF) and its receptor
(EGFR [HER1; ErbB1]) have been identified
as key drivers in the process of cell growth and proliferation for
normal and cancer cells. EGFR activating mutation within a cancer cell
is an important factor in the promotion of
tumour cell growth, blocking of apoptosis, increasing the production
of angiogenic factors and facilitating the processes of metastasis.
Gefitinib is a selective small molecule
inhibitor of the epidermal growth factor receptor tyrosine kinase and
is an effective treatment for patients with tumours with activating
mutations of the EGFR tyrosine kinase
domain regardless of line of therapy. No clinically relevant activity
has been shown in patients with known EGFR mutation-negative tumours.
Most NSCLC tumours with sensitising
EGFR kinase mutations eventually develop resistance to Gefitinib
treatment, with a median time to disease progression of 1 year.
PHARMACOKINETICS:
_Absorption:_ Following oral administration of Gefitinib, absorption
is moderately slow and peak plasma concentrations of Gefitinib
typically occur at 3 to 7 hours after administration.
Exposure to Gefitinib is not significantly altered by food.
_Distribution: _Gefitinib has a mean steady-state volume of
distribution of 1400 l indicating extensive distribution into tissue.
Plasma protein binding is approximately 90%. Gefitinib
binds to serum albumin and alpha 1-acid glycoprotein.
_Biotransformation: _Gefitinib is extensively metabolised in humans.
Five metabolites have been fully identified in excreta and 8
metabolites in plasma where the major metabolite
identified was O-desme