Tarlonib 25 (Erlotinib Tablets 25mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ERLOTINIB HYDROCHLORIDE

Boleh didapati daripada:

RANBAXY (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ERLOTINIB HYDROCHLORIDE

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

Sun Pharmaceutical Industries Ltd.

Risalah maklumat

TARLONIB
Page 1
_Consumer Medication Information Leafleat (RiMUP)_
TARLONIB
_ _
(ERLOTINIB TABLETS 25, 100, 150 MG
)
_ _
WHAT IS IN THIS LEAFLET
1. What
TARLONIB
is used for
2. How
TARLONIB
works
3. Before you use
TARLONIB
4. How to use
TARLONIB
5. While you are using
TARLONIB
6. Side Effects
7. Storage and Disposal of
TARLONIB
8. Product Description
9. Manufacturer
10. Product Registration Holder
11. Date of Revision
This leaflet answers some common
questions about
TARLONIB
It does not contain all of the available
information. It does not take the place
of talking to your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking
TARLONIB
against the
benefits it is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT TARLONIB IS USED FOR
TARLONIB
is used to treat the cancer
by preventing the activity of a protein
called epidermal growth factor receptor
(EGFR).
TARLONIB
is
indicated
for
adults.
This medicine can be prescribed to you
if you have non-small cell lung cancer
at
an
advanced
stage.
It
can
be
prescribed
as
initial
therapy
or
as
therapy if your disease remains largely
unchanged after initial chemotherapy,
provided
your
cancer
cells
have
specific EGFR mutations. It can also
be prescribed if previous chemotherapy
has not helped to stop your disease.
This medicine can also be prescribed to
you
in
combination
with
another
treatment
called
gemcitabine
if
you
have
cancer
of
the
pancreas
at
a
metastatic stage.
HOW TARLONIB WORKS
TARLONIB
contains
the
active
substance
erlotinib.
TARLONIB
is
used to treat the cancer by preventing
the
activity
of
a
protein
called
epidermal
growth
factor
receptor
(EGFR). This protein is known to be
involved in the growth and spread of
cancer cells.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
TARLONIB
HAS BEEN PRESCRIBED FOR YOU.
This product is available as 25 mg, 100
mg and 150 mg
strengths.
BEFO

Ciri produk

1
_For the Use of a Registered Medical Practitioner only_
PRESCRIBING INFORMATION
TARLONIB 25, 100 AND 150
(ERLOTINIB TABLETS 25 MG, 100 MG AND 150 MG)
COMPOSITION
TARLONIB 25
Each film-coated tablet contains
Erlotinib (as erlotinib hydrochloride)….. 25 mg
TARLONIB 100
Each film-coated tablet contains
Erlotinib (as erlotinib hydrochloride)….. 100 mg
TARLONIB 150
Each film-coated tablet contains
Erlotinib (as erlotinib hydrochloride)….. 150 mg
Excipients_: _ Lactose Monohydrate, Microcrystalline cellulose, Sodium
starch glycolate, Sodium
lauryl sulphate, Magnesium stearate, Microcrystalline cellulose,
Opadry.
PRODUCT DESCRIPTION
TARLONIB 25 are are white to off white round biconvex film coated
tablets debossed with "RL"
on one side and "11" on other side.
TARLONIB 100 are White to off white round biconvex film coated tablets
debossed with "RL"
on one side and "12" on other side.
TARLONIB 150 are White to off white round biconvex film coated tablets
debossed with "RL"
on one side and "13" on other side.
2
PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES
PHARMACODYNAMICS
Erlotinib is an epidermal growth factor receptor/human epidermal
growth factor receptor type 1
(EGFR also known as HER1) tyrosine kinase inhibitor. Erlotinib
potently inhibits the intracellular
phosphorylation of EGFR. EGFR is expressed on the cell surface of
normal cells and cancer cells. It
is reported that the inhibition of EGFR phosphotyrosine results in
cell stasis and/or death.
EGFR mutations may lead to constitutive activation of anti-apoptotic
and proliferation signaling
pathways. The potent effectiveness of erlotinib in blocking
EGFR-mediated signalling in these
EGFR mutation positive tumours is attributed to the tight binding of
erlotinib to the ATP-binding site
in the mutated kinase domain of the EGFR. Due to the blocking of
downstream-signaling, the
proliferation of cells is stopped, and cell death is induced through
the intrinsic apoptotic pathway.
Tumour regression has been reported in mouse models of enforced
expression of these E