Tarceva Film Coated Tablet 25mg

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ERLOTINIB HYDROCHLORIDE

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

ERLOTINIB HYDROCHLORIDE

Unit dalam pakej:

30Tablet Tablets

Dikeluarkan oleh:

Delpharm Milano s.r.l

Risalah maklumat

_ _
_ _
_Consumer Medication Information Leaflet (RiMUP) _
_ _
TARCEVA
®
_Contains active ingredient Erlotinib(25mg, 100mg, 150mg) _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Tarceva is used for
2.
How Tarceva works
3.
Before you use Tarceva
4.
How to use Tarceva
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Tarceva
8.
Product Description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of Revision
12.
Serial Number
1.
WHAT TARCEVA IS USED FOR
Tarceva
contains
the
active
ingredient erlotinib.
Tarceva 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 if your
cancer
cells
have
specific
EGFR
mutations. It can also be prescribed
if
your
disease
remains
largely
unchanged
after
initial
chemotherapy,
or
if
previous
chemotherapy has not helped to stop
your disease.
Tarceva is also used in combination
with gemcitabine for the treatment
of pancreatic cancer.
This medicine is available only with
a doctor's prescription.
2.
HOW TARCEVA WORKS
As
a
targeted
cancer
treatment,
Tarceva targets a specific protein on
the surface of the cancer cells called
EGFR/
HER1
(epidermal
growth
factor receptor 1). It slows or blocks
the activity of EGFR and may cause
the
cancer
cells
to
die,
with
potentially
less
damage
to
normal
cells.
However,
the
way
Tarceva
works
to
treat
cancer
is
not
fully
known.
3.
BEFORE YOU USE TARCEVA
-
_WHEN YOU MUST NOT USE IT _
DO NOT TAKE TARCEVA IF:
1.
you
have
had
an
allergic
reaction
to
Tarceva
or
any
ingredients listed at the end
of this leaflet
2.
the package is torn or shows_ _
signs of tampering.
3.
the expiry date (EXP) printed
on the pack has passed.
If you take this medicine after
the
expiry
date
has
passed,
it
may not work as well.
If you are not sure if you should
be taking Tarceva, talk to your
doctor.
_ _
_USE IN CHILDREN _
Do not give Tarceva to children.
Safety
and
effectiveness
in
patients less than 18 years of age
have not been established.
-
_BEFORE YOU

Ciri produk

PACK INSERT FOR MALAYSIA

Tarceva
®
Erlotinib

1. DESCRIPTION
1.1 Therapeutic / Pharmacologic Class of Drug
Antineoplastic agent.
ATC code L01EB02
1.2 Type of Dosage Form
Tarceva film-coated tablets 25 mg, 100 mg, 150 mg.
Film-coated white to yellowish, round, biconvex tablets, with ‘T25
or T100 or T150’
engraved on one side according to tablet strength.
1.3 Route of Administration
Oral.
1.4 Qualitative and Quantitative Composition
Active ingredient: erlotinib hydrochloride.
One film-coated tablet of each strength contains erlotinib
hydrochloride, corresponding
to 25 mg, 100 mg and 150 mg of erlotinib.
List of excipient
Tablet core
Lactose monohydrate
Ph. Eur./USP/JP
Cellulose, microcrystalline
Ph. Eur./USP/JP
Sodium starch glycolate
Ph. Eur./USP/JPE
Sodium laurilsulfate
Ph. Eur./USP/JP
Magnesium stearate
Ph. Eur./USP/JP
Tablet coat
Hydroxypropyl cellulose
Ph. Eur./USP/JP
Titanium dioxide
Ph. Eur./USP/JP
Polyethylene glycol
Ph. Eur./ NF/JP
Hydroxypropyl methylcellulose
Ph. Eur./USP/JP
2. CLINICAL PARTICULARS
2.1 Therapeutic Indication(s)
Non-small cell lung cancer
Tarceva is indicated for the first-line treatment of patients with
locally advanced or
metastatic non-small cell lung cancer (NSCLC) with EGFR activating
mutations.
Tarceva is indicated for maintenance treatment in patients with
locally advanced or
metastatic NSCLC with EGFR activating mutations who have not
progressed after first-
line chemotherapy.
Tarceva is also indicated for the treatment of patients with locally
advanced or metastatic
NSCLC after failure of at least one prior chemotherapy regimen.
Pancreatic Cancer
Tarceva in combination with gemcitabine is indicated for the treatment
of patients with
locally advanced, unresectable or metastatic pancreatic cancer
2.2 Dosage and Administration
2.2.1 Standard Dosage
Non-small cell lung cancer
EGFR mutation testing should be performed prior to initiation of
Tarceva as first-line or
maintenance therapy in patients with locallyadvanced or metastatic
NSCLC.
The recommended daily dose of