Iclusig

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Ponatinib

Available from:

Incyte Biosciences Distribution B.V.

ATC code:

L01EA05

INN (International Name):

ponatinib

Therapeutic group:

Antineoplastic agents, Protein kinase inhibitors

Therapeutic area:

Leukemia, Myeloid; Leukemia, Lymphoid

Therapeutic indications:

Iclusig is indicated in adult patients withchronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutationPhiladelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.See sections 4.2 Assessment of cardiovascular status prior to start of therapy and 4.4 situations where an alternative treatment may be considered.

Product summary:

Revision: 25

Authorization status:

Authorised

Authorization date:

2013-07-01

Patient Information leaflet

39
B. PACKAGE LEAFLET
40
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ICLUSIG 15 MG FILM-COATED TABLETS
ICLUSIG 30 MG FILM-COATED TABLETS
ICLUSIG 45 MG FILM-COATED TABLETS
ponatinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Iclusig is and what it is used for
2.
What you need to know before you take Iclusig
3.
How to take Iclusig
4.
Possible side effects
5.
How to store Iclusig
6.
Contents of the pack and other information
1.
WHAT ICLUSIG IS AND WHAT IT 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 become rearranged
to form an abnormal chromosome, the Philadelphia chromosome.
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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ICLUSIG
DO NOT TAKE ICL

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Iclusig 15 mg film-coated tablets
Iclusig 30 mg film-coated tablets
Iclusig 45 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Iclusig 15 mg film-coated tablets
Each film-coated tablet contains 15 mg of ponatinib (as
hydrochloride).
_Excipients with known effect _
Each film-coated tablet contains 40 mg of lactose monohydrate.
Iclusig 30 mg film-coated tablets
Each film-coated tablet contains 30 mg of ponatinib (as
hydrochloride).
_Excipients with known effect _
Each film-coated tablet contains 80 mg of lactose monohydrate.
Iclusig 45 mg film-coated tablets
Each film-coated tablet contains 45 mg of ponatinib (as
hydrochloride).
_Excipients with known effect _
Each 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).
Iclusig 15 mg film-coated tablets
White, biconvex, round film-coated tablet that is approximately 6 mm
in diameter, with "A5"
debossed on one side.
Iclusig 30 mg film-coated tablets
White, biconvex, round film-coated tablet that is approximately 8 mm
in diameter, with "C7" debossed
on one side.
Iclusig 45 mg film-coated tablets
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 with
•
chronic phase, accelerated phase, or blast phase chronic myeloid
leukaemia (CML) who are
resistant to dasatinib or nilotinib; who are intolerant to dasatinib
or nilotinib and for whom
subsequent treatment with imatinib is not clinically appropriate; or
who have the T315I
mutation
3
•
Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+
ALL) who are resistant
to dasatinib; who are intolerant to dasatinib and for whom subsequent
treatment with imatinib is
not clinically appropriate; or who have the T315I mutation.
See sections 4.2 for the assessm