ICLUSIG ponatinib (as hydrochloride) 15 mg film-coated tablet bottle

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

ponatinib hydrochloride, Quantity: 16 mg (Equivalent: ponatinib, Qty 15 mg)

Beschikbaar vanaf:

Takeda Pharmaceuticals Australia Pty Ltd

INN (Algemene Internationale Benaming):

ponatinib hydrochloride

farmaceutische vorm:

Tablet, film coated

Samenstelling:

Excipient Ingredients: sodium starch glycollate; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; microcrystalline cellulose; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350

Toedieningsweg:

Oral

Eenheden in pakket:

Bottles of 30 tablets, Bottles of 60 tablets

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

ICLUSIG is indicated for the treatment of adult patients with:,Chronic phase (CP), accelerated phase (AP), or blast phase (BP) chronic myeloid Ieukaemia (CML) whose disease is resistant to, or who are intolerant of at least two prior tyrosine kinase inhibitors; or where there is a T315I mutation.,Philadelphia chromosome positive acute lymphoblastic Ieukaemia (Ph+ ALL) whose disease is resistant to, or who are intolerant of dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or where there is a T315I mutation.,Therapy with ICLUSIG should be initiated and monitored by a haematologist with expertise in managing adult Ieukaemias.

Product samenvatting:

Visual Identification: Tablets are white, biconvex, round film-coated tablets debossed with 'A5' on one side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Autorisatie-status:

Licence status A

Autorisatie datum:

2014-11-26

Bijsluiter

ICLUSIG
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING ICLUSIG?
ICLUSIG contains the active ingredient ponatinib hydrochloride.
ICLUSIG is used to treat adults with certain types of leukaemia.
For more information, see Section 1. Why am I using ICLUSIG? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ICLUSIG?
Do not use if you have ever had an allergic reaction to ICLUSIG or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ICLUSIG? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ICLUSIG and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE ICLUSIG?
•
You should follow all directions on how to use ICLUSIG given by your
doctor or pharmacist
More instructions can be found in Section 4. How do I use ICLUSIG? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ICLUSIG?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ICLUSIG. If you are pregnant,
intending to get pregnant or to father a child, tell your doctor
immediately.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine without talking to your doctor first.
DRIVING
OR USING
MACHINES
•
Be careful driving or operating machinery until you know how ICLUSIG
affects you.
DRINKING
ALCOHOL
•
Tell your doctor if you have a history of alcohol abuse.
LOOKING AF

Productkenmerken

ICLUSIG PI V4.0 (CCDS V12.1)
_ _
_1 _
AUSTRALIAN PRODUCT INFORMATION
ICLUSIG
®
(PONATINIB HYDROCHLORIDE)
WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS,
HEART FAILURE, HYPERTENSION AND HEPATOTOXICITY
•
ARTERIAL OCCLUSIVE EVENTS (AOES), INCLUDING FATALITY, HAVE OCCURRED IN
ICLUSIG-TREATED
PATIENTS. AOES INCLUDING FATAL MYOCARDIAL INFARCTION, STROKE, STENOSIS
OF LARGE ARTERIAL
VESSELS OF THE BRAIN, SEVERE PERIPHERAL VASCULAR DISEASE (SOMETIMES
RESULTING IN
AMPUTATION), VISION LOSS, AND THE NEED FOR URGENT REVASCULARISATION
PROCEDURES.
PATIENTS WITH AND WITHOUT CARDIOVASCULAR RISK FACTORS, INCLUDING
PATIENTS LESS THAN 50
YEARS OLD, EXPERIENCED THESE EVENTS. MONITOR FOR EVIDENCE OF AOES.
INTERRUPT OR
STOP ICLUSIG BASED ON SEVERITY. CONSIDER BENEFIT-RISK TO GUIDE
DECISION TO RESTART
ICLUSIG
•
VENOUS THROMBOEMBOLIC EVENTS (VTES) HAVE OCCURRED IN ICLUSIG-TREATED
PATIENTS.
MONITOR FOR EVIDENCE OF VTES. INTERRUPT OR STOP ICLUSIG BASED ON
SEVERITY.
•
HEART FAILURE, INCLUDING FATALITIES, OCCURRED IN ICLUSIG-TREATED
PATIENTS. MONITOR
CARDIAC FUNCTION. INTERRUPT OR STOP ICLUSIG FOR NEW OR WORSENING HEART
FAILURE
•
HYPERTENSION, INCLUDING HYPERTENSIVE CRISIS, HAS BEEN OBSERVED IN
ICLUSIG-TREATED
PATIENTS.
•
HEPATOTOXICITY, INCLUDING LIVER FAILURE AND DEATH HAVE OCCURRED IN
ICLUSIG-TREATED
PATIENTS. MONITOR HEPATIC FUNCTION. INTERRUPT ICLUSIG BASED ON
SEVERITY.
SEE SECTION 4.4 SPECIAL WARNING AND PRECAUTIONS FOR USE – ARTERIAL
OCCLUSION, VENOUS
THROMBOEMBOLISM, HEART FAILURE, HYPERTENSION AND HEPATOTOXICITY
1
NAME OF THE MEDICINE
Ponatinib (as hydrochloride)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains ponatinib hydrochloride equivalent to 10, 15, 30,
or 45 mg ponatinib.
Excipients with known effect: Lactose monohydrate. For the full list
of excipients, see Section 6.1
List of excipients.
3
PHARMACEUTICAL FORM
ICLUSIG tablets are available for oral administration.
10 mg Tablet: White to off-white, biconvex, oval film-coated tablet
with “NZ” debossed on one side.
15 mg Tablet