GIOTRIF 50MG FILM-COATED TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

AFATINIB DIMALEATE

Boleh didapati daripada:

BOEHRINGER INGELHEIM (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

AFATINIB DIMALEATE

Unit dalam pakej:

28tablet Tablets

Dikeluarkan oleh:

Boehringer Ingelheim Pharma GmbH & CoKG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
GIOTRIF
® FILM COATED TABLETS
Afatinib (20mg, 30mg, 40mg, 50mg)
1
WHAT IS IN THIS LEAFLET:
1.
What GIOTRIF is used for
2.
How GIOTRIF works
3.
Before you use
GIOTRIF
4.
How to use GIOTRIF
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
GIOTRIF
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT GIOTRIF IS USED FOR
GIOTRIF is used on its own to treat
adult patients with a specific type of
cancer of the lung (non-small cell lung
cancer) that is identified by
i)
a change (mutation) in the gene
for EGFR: GIOTRIF can be
prescribed to you as your first
treatment or if prior chemotherapy
treatment has been insufficient.
ii)
for patients carrying specific cell
type (squamous cell) if prior
chemotherapy treatment has been
insufficient.
HOW GIOTRIF WORKS
GIOTRIF is a medicine which contains
the active substance afatinib. It works
by blocking the activity of a group of
proteins called the ErbB family
(including EGFR [epidermal growth
factor receptor or ErbB1], HER2
[ErbB2], ErbB3 and ErbB4). These
proteins are involved in the growth and
spread of cancer cells, and can be
affected by changes (mutations) in the
genes that produce them. By blocking
the activity of these proteins this
medicine can inhibit growth and spread
of cancer cells.
BEFORE YOU USE GIOTRIF
-
_When you must not use it _
If you are allergic to afatinib or any of
the other ingredients of this medicine
(listed in section 8).
CHILDREN AND ADOLESCENTS
GIOTRIF has not been studied in
children or adolescents. Do not give
this medicine to children or
adolescents under the age of 18 years.
PREGNANCY AND BREAST-FEEDING
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist
for advice before
taking this medicine.
_Pregnancy _
You should avoid becoming pregnant
while taking this medicine. If you
could become pregnant, you should
use adequate birth control methods
during treatmen

Ciri produk

1 | P a g e
GIOTRIF
®
Abcd
1. NAME OF THE MEDICINAL PRODUCT
GIOTRIF 20 mg film-coated tablets
GIOTRIF 30 mg film-coated tablets
GIOTRIF 40 mg film-coated tablets
GIOTRIF 50 mg film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 20 mg, 30 mg, 40 mg or 50 mg afatinib
(as dimaleate).
Excipient with known effect:
GIOTRIF 20 mg: One film-coated tablet contains 118 mg lactose (as
monohydrate).
GIOTRIF 30 mg: One film-coated tablet contains 176 mg lactose (as
monohydrate).
GIOTRIF 40 mg: One film-coated tablet contains 235 mg lactose (as
monohydrate).
GIOTRIF 50 mg: One film-coated tablet contains 294 mg lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
GIOTRIF 20 mg: White to yellowish, round, biconvex and bevel-edged
film-coated tablet debossed with
the code “T20” on one side and the Boehringer Ingelheim company
logo on the other.
GIOTRIF 30 mg: Dark blue, round, biconvex and bevel-edged film-coated
tablet debossed with the code
“T30” on one side and the Boehringer Ingelheim company logo on the
other.
GIOTRIF 40 mg: Light blue, round, biconvex and bevel-edged film-coated
tablet debossed with the code
“T40” on one side and the Boehringer Ingelheim company logo on the
other.
GIOTRIF 50 mg: Dark blue, oval, biconvex film-coated tablet debossed
with the code “T50” on one side
and the Boehringer Ingelheim company logo on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GIOTRIF as monotherapy is indicated for the treatment of
•
Epidermal Growth Factor Receptor (EGFR) TKI-naïve adult patients with
locally advanced or
metastatic non-small cell lung cancer (NSCLC) with activating EGFR
mutation(s);
•
Locally advanced or metastatic NSCLC of squamous histology progressing
on or after platinum-
based chemotherapy (see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
2 | P a g e
Treatment with GIOTRIF should be initiated and supervised by a
physician experienced in the use of
an