ICLUSIG 15 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

PONATINIB AS HYDROCHLORIDE

Available from:

INCYTE BIOSCIENCES ISRAEL LTD, ISRAEL

ATC code:

L01XE24

Pharmaceutical form:

COATED TABLETS

Composition:

PONATINIB AS HYDROCHLORIDE 15 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

INCYTE BIOSCIENCES UK LTD, UK

Therapeutic area:

PONATINIB

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 • 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.

Authorization date:

2015-03-12

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine can be sold with a doctor's prescription only
WARNING: VASCULAR OCCLUSION, HEART FAILURE AND HEPATOTOXICITY.
VASCULAR OCCLUSION: BLOOD CLOTS IN THE ARTERIES AND VEINS, AND
VASCULAR
OCCLUSION OCCURRED IN APPROXIMATELY 27% OF PATIENTS TREATED WITH
ICLUSIG,
INCLUDING FATAL MYOCARDIAL INFARCTION, STROKE, STENOSIS OF LARGE
ARTERIAL VESSELS
OF THE BRAIN, SEVERE PERIPHERAL VASCULAR DISEASE
AND THE NEED FOR URGENT
REVASCULARIZATION PROCEDURES.
PATIENTS WITH AND WITHOUT CARDIAC RISK FACTORS, INCLUDING THOSE UNDER
50 YEARS
OF AGE, HAVE EXPERIENCED THESE SYMPTOMS.
HEART FAILURE, INCLUDING CASES THAT CAUSED DEATH, OCCURRED IN 8% OF
PATIENTS
TREATED WITH ICLUSIG.
HEPATOTOXICITY, LIVER FAILURE AND DEATH OCCURRED IN PATIENTS TREATED
WITH ICLUSIG.
ICLUSIG 15 MG FILM-COATED TABLETS
ICLUSIG 30 MG FILM-COATED TABLETS
ICLUSIG 45 MG FILM-COATED TABLETS
EACH 15 MG ICLUSIG TABLET CONTAINS 15 MG OF PONATINIB (AS
HYDROCHLORIDE).
EACH 30 MG ICLUSIG TABLET CONTAINS 30 MG OF PONATINIB (AS
HYDROCHLORIDE).
EACH 45 MG ICLUSIG TABLET CONTAINS 45 MG OF PONATINIB (AS
HYDROCHLORIDE).
Excipients and allergens: see section 6 (Additional Information) of
this leaflet.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE. This
leaflet contains concise information about the medicine. If you have
any further
questions, ask your doctor or pharmacist.
This medicine has been prescribed for your illness. Do not pass it on
to others. It may
harm them
even if you think that their illness is the same as yours.
This medicine is intended for use in adults above age 18 only.
1. WHAT IS THE MEDICINE INTENDED FOR?
THIS MEDICINE IS INTENDED TO TREAT ADULTS with the following LEUKEMIA
types, when
other treatments are no longer effective or who have a genetic
alteration known as a
T315I mutation:
•
Chronic myeloid leukemia (CML)
•
Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+
ALL)
THERAPEUTIC GROUP:
Iclusig belongs to

Summary of Product characteristics

1
This leaflet format has been determined by the Ministry of the Health
and the content has been
checked and approved in 07/10/2018 The content of this leaflet was
updated according to the
guidelines of the Ministry of Health in October 201
9
PHYSICIAN PRESCRIBING INFORMATION
WARNING: VASCULAR OCCLUSION, HEART FAILURE, AND HEPATOTOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING _
VASCULAR OCCLUSION: ARTERIAL AND VENOUS THROMBOSIS AND OCCLUSIONS HAVE
OCCURRED IN AT LEAST
27% OF ICLUSIG TREATED PATIENTS, INCLUDING FATAL MYOCARDIAL
INFARCTION, STROKE, STENOSIS OF LARGE
ARTERIAL VESSELS OF THE BRAIN, SEVERE PERIPHERAL VASCULAR DISEASE, AND
THE NEED FOR URGENT
REVASCULARIZATION PROCEDURES.
PATIENTS WITH AND WITHOUT CARDIO VASCULAR RISK FACTORS, INCLUDING
PATIENTS LESS THAN 50 YEARS OLD,
EXPERIENCED THESE EVENTS. MONITOR FOR EVIDENCE OF THROMBOEMBOLISM AND
VASCULAR OCCLUSION.
INTERRUPT OR STOP ICLUSIG IMMEDIATELY FOR VASCULAR OCCLUSION.
HEART FAILURE, INCLUDING FATALITIES, OCCURRED IN 8% OF ICLUSIG-TREATED
PATIENTS. MONITOR CARDIAC
FUNCTION. INTERRUPT OR STOP ICLUSIG FOR NEW OR WORSENING HEART
FAILURE.
HEPATOTOXICITY, LIVER FAILURE AND DEATH HAVE OCCURRED IN
ICLUSIG-TREATED PATIENTS. MONITOR
HEPATIC FUNCTION. INTERRUPT ICLUSIG IF HEPATOTOXICITY IS SUSPECTED.
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