ICLUSIG FILM-COATED TABLET 15 MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Ponatinib Free Base (added as ponatinib HCl)

Boleh didapati daripada:

SMART MEDICINE SDN. BHD.

INN (Nama Antarabangsa):

Ponatinib Free Base (added as ponatinib HCl)

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

PATHEON INC.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
_ _
Page 1
ICLUSIG
®
FILM-COATED TABLETS
Ponatinib (15 mg and 45 mg)
WHAT IS IN THIS LEAFLET
1.
WHAT IS ICLUSIG USED FOR
2.
HOW ICLUSIG WORKS
3.
BEFORE YOU USE ICLUSIG
4.
HOW TO USE ICLUSIG
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE
AND
DISPOSAL
OF
ICLUSIG
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER
AND
PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
Please
refer
to
the
Patient
Medication Guide that comes with
Iclusig before you start using it and
each time you get a refill. There may
be
new
information.
This
information does not take the place
of
talking
to
your
healthcare
provider
about
your
medical
condition or your treatment. If you
have any questions about Iclusig,
ask your healthcare provider.
WHAT ICLUSIG IS USED FOR
Iclusig is used to treat adults with the
following leukaemia types who are
no longer benefiting from treatment
with
other
medicines,
or
have
a
certain genetic difference known as
a T315I mutation:
-
_Chronic _
_myeloid _
_leukaemia _
(CML):
a
blood
cancer
involving too many abnormal
white blood cells in the blood
and the bone marrow (where
blood cells are formed).
-
_Philadelphia-chromosome_
positive
acute
lymphoblastic
leukaemia (Ph+ ALL): a type of
leukaemia involving too many
immature white blood cells in
the
blood
and
blood
forming
bone marrow. In this kind of
leukaemia, some of the DNA
(genetic material) has
-
rearranged to form an abnormal
chromosome, the Philadelphia
chromosome.
HOW ICLUSIG WORKS
Iclusig belongs to a group of medicines
called
tyrosine
kinase
inhibitors.
In
patients
with
CML
and
Ph+
ALL,
changes in the DNA trigger a signal that
tells
the
body
to
produce
abnormal
white blood cells. Iclusig blocks this
signal, thereby stopping the production
of these cells.
BEFORE YOU USE ICLUSIG
_WHEN YOU MUST NOT USE IT _
Do not take Iclusig if you are allergic to
ponatinib or any of the other ingredients
of this medicine. See the end of this
leaflet for a list of ingredients in Iclusig.
_BEFORE YOU START TO USE

Ciri produk

1
ICLUSIG
® TABLETS
PONATINIB
1.
NAME OF THE MEDICINAL PRODUCT
Iclusig 15 mg and 45 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 mg film-coated tablet contains 15 mg of ponatinib (as
hydrochloride). Each 45 mg film-coated
tablet contains 45 mg of ponatinib (as hydrochloride).
Excipients with known effect
Each 15 mg film-coated tablet contains 40 mg of lactose monohydrate.
Each 45 mg film-coated tablet
contains 120 mg of lactose monohydrate. For the full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
15 mg: White, biconvex, round film-coated tablet that is approximately
6 mm in diameter, with "A5"
debossed on one side.
45 mg: White, biconvex, round film-coated tablet that is approximately
9 mm in diameter, with “AP4”
debossed on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Iclusig is indicated in adult patients suffering from:
•
Philadelphia-positive (Ph+) chronic myeloid leukaemia (chronic phase,
accelerated phase or blast
phase) or Ph+ acute lymphoblastic leukaemia for whom a treatment with
other c-abl tyrosine kinase
inhibitors is not appropriate, or
•
T315I-positive Ph+ chronic myeloid leukaemia (chronic phase,
accelerated phase, or blast phase) or
T315I-positive Ph+ acute lymphoblastic leukaemia.
See sections 4.2 for the assessment of cardiovascular status prior to
start of therapy and 4.4 for situations
where an alternative treatment may be considered.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
diagnosis and treatment of patients with
leukaemia. Haematologic support such as platelet transfusion and
haematopoietic growth factors can be used
during treatment if clinically indicated.
Before starting treatment with ponatinib, the cardiovascular status of
the patient should be assessed,
including history and physical examination, and cardiovascular risk
factors should be actively managed.
Cardiovascular status should continue to be monitored and medical and