ICLUSIG 15 MG

Ország: Izrael

Nyelv: angol

Forrás: Ministry of Health

Aktív összetevők:

PONATINIB AS HYDROCHLORIDE

Beszerezhető a:

MEDISON PHARMA LTD

ATC-kód:

L01XE24

Gyógyszerészeti forma:

COATED TABLETS

Összetétel:

PONATINIB AS HYDROCHLORIDE 15 MG

Az alkalmazás módja:

PER OS

Recept típusa:

Required

Gyártó:

INCYTE BIOSCIENCES DISTRIBUTION B.V., NETHERLANDS

Terápiás terület:

PONATINIB

Terápiás javallatok:

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.

Engedély dátuma:

2020-02-29

Betegtájékoztató

Iclusig- PIL-0522-V1
Iclusig-15_30_45mg-PIL-ENG-D14-F
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine can be sold with a doctor's prescription only
ICLUSIG 15 MG COATED TABLETS
ICLUSIG 30 MG COATED TABLETS
ICLUSIG 45 MG 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).
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.
Excipients and allergens: see section 2 under 'Important information
about some of
this medicine's ingredients' and section 6 'Additional information'.
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)
•

Termékjellemzők

1
PHYSICIAN PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
ICLUSIG 15 MG COATED TABLETS
ICLUSIG 30 MG COATED TABLETS
ICLUSIG 45 MG 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.
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
2
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.
HEA