Iclusig 45mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ponatinib hydrochloride

Available from:

Incyte Biosciences UK Ltd

ATC code:

L01XE24

INN (International Name):

Ponatinib hydrochloride

Dosage:

45mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 7640159430735

Patient Information leaflet

1
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
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 s

Summary of Product characteristics

OBJECT 1
ICLUSIG 15MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 12-Jun-2018 | Incyte
Biosciences UK Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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