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.
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.
3. What if I am taking other medicines?
Some medicines may interfere with ICLUSIG and affect how it works.
4. How do I use ICLUSIG?
You should follow all directions on how to use ICLUSIG given by your doctor or pharmacist
5. What should I know while using ICLUSIG?
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Things you should do
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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.
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Things you should not do
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Do not stop using this medicine without talking to your doctor first.
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Driving or using machines
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Be careful driving or operating machinery until you know how ICLUSIG affects you.
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Drinking alcohol
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Tell your doctor if you have a history of alcohol abuse.
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Looking after your medicine
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Store the tablets in the original container to protect from light.
Keep the medicine in a cool, dry place where temperature stays below 30°C.
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6. Are there any side effects?
Severe side effects include chest pain, shortness of breath, weakness in one side,
fast or irregular heartbeats, leg or abdominal swelling, sudden weigh gain, jaundice,
loss of appetite, elevated blood pressure, severe headache, nausea, vomiting, severe
abdominal pain, unusual bleeding or easy bruising, low blood cell counts, fever, chills.
Common side effects include upper respiratory tract infection, pneumonia, skin rash,
sleeplessness, dry or blurred eye, conjunctivitis, rash, dry skin, pruritus.
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.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
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WARNING: The following adverse effects have been observed in some ICLUSIG-treated
patients in the main clinical trial. Therefore, your medical condition will be monitored
during ICLUSIG treatment with interruption or stoppage of the treatment if decided
necessary by your doctor:
Complete or partial blockage of a blood artery: occurred in ICLUSIG-treated patients
in the main clinical trial, resulting in heart attack or chest pain, stroke, narrowing
of blood vessels, vision loss, severe blood circulation disorder (sometimes resulting
in amputation), and the need for urgent surgical procedure to widen the blocked or
narrowed arteries.
Blockage of blood vein due to a blood clot
Heart failure
High blood pressure including a marked proportion graded as severe
Liver toxicities including fatal liver failure.
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Active ingredient(s):
ponatinib (pon-a-tin-ib) hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ICLUSIG.
You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ICLUSIG. The information in this leaflet was last updated on the date listed on the final
page. More recent information on the medicine may be available. You should ensure
that you speak to your pharmacist or doctor to obtain the most up to date information
on this medicine. You can also download the most up to date leaflet from
www.takeda.com/en-au . Those updates may contain important information about the medicine and its use of
which you should be aware.
Where to find information in this leaflet:
1. Why am I using ICLUSIG?
ICLUSIG contains the active ingredient ponatinib hydrochloride. 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.
ICLUSIG is used to treat adults with the following types of leukaemia who are no longer benefiting from
treatment with other medicines:
Chronic myeloid leukaemia (CML): a blood cancer (leukaemia) involving too many abnormal
white blood cells (granulocytes), in the blood and the bone marrow (where blood cells
are formed)
Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): another
type of leukaemia involving too many immature white blood cells (lymphocytes or lymphoblasts),
in the blood and blood-forming bone marrow.
In both types of leukaemia, some of the DNA (genetic material) has become rearranged
to form an abnormal chromosome, called the Philadelphia chromosome.
This medicine is only available with a prescription from a doctor experienced with
leukaemia treatment.
2. What should I know before I use ICLUSIG?
Warnings
Do not use ICLUSIG if:
you are allergic to ponatinib, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you have:
a history of blood clots in your blood vessels (arteries or veins)
heart problems, for example heart failure, irregular heartbeats, a condition called
QT prolongation or a prior heart attack
a history of stroke
high blood pressure
diabetes
high cholesterol
bleeding problems
liver or kidney problems
a pancreas disorder
a history of alcohol abuse
hepatitis B
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant, intending to become pregnant or to father
a child.
You and your partner must use effective contraception during your treatment with this
medicine.
Women of childbearing age being treated with ICLUSIG should avoid becoming pregnant,
as potential risks exist for the unborn child.
Men being treated with ICLUSIG should avoid fathering a child during treatment.
You must not breastfeed during treatment with ICLUSIG. It is not known if ICLUSIG
passes into breast milk.
Your doctor can discuss with you the risks involved.
Tell your doctor if you are lactose intolerant. ICLUSIG tablets contain lactose.
If you have not told your doctor or pharmacist about any of the above, tell them before
you take ICLUSIG.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines and ICLUSIG may interfere with each other. These include:
ketoconazole, itraconazole, voriconazole: medicines used to treat fungal infections
atazanavir, indinavir, nelfinavir, ritonavir, saquinavir: medicines used to treat
HIV infection
clarithromycin, telithromycin, troleandomycin: medicines used to treat bacterial infections
nefazodone, a medicine to treat depression
St. John’s Wort, a herbal product used to treat depression
carbamazepine, a medicine to treat epilepsy, euphoric/depressive stages and certain
pain conditions
phenobarbital, phenytoin: medicines used to treat epilepsy
rifabutin, rifampicin: medicines used to treat tuberculosis or other infections
medicines which decrease stomach acid such as omeprazole, pantoprazole, ranitidine,
cimetidine, famotidine, aluminum, and magnesium hydroxides
digoxin: a medicine used to treat heart weakness
dabigatran: a medicine used to prevent the formation of blood clots
colchicine: a medicine used to treat gout attacks
pravastatin, rosuvastatin, medicines used to lower cholesterol
methotrexate, a medicine used to treat arthritis, cancer and some skin diseases
sulfasalazine, a medicine used to treat severe bowel and rheumatic joint inflammation.
These medicines may be affected by ICLUSIG or may affect how well it works. You may
need to use different amounts of your medicine or take different medicines.
Avoid grapefruit products such as grapefruit juice, or Seville orange-based products
such as marmalade.
These products may contain components that alter the metabolism of some medicines,
including ICLUSIG.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ICLUSIG.
4. How do I use ICLUSIG?
ICLUSIG should only be prescribed by a doctor experienced in leukaemia treatment.
Follow all directions given to you by your doctor or pharmacist carefully.
They may differ from the information contained in this leaflet.
If you do not understand the instructions, ask your doctor or pharmacist for help.
How much to take
The recommended starting dose is one 45 mg tablet once daily.
Your doctor may reduce your dose or tell you to temporarily stop taking ICLUSIG if:
the number of white blood cells, called neutrophils, is reduced
the number of blood platelets is reduced
a severe side effect occurs, not affecting the blood, for example if you develop:
pancreas inflammation
increased levels of serum protein lipase or amylase
liver inflammation and/or increased levels of liver enzymes, such as liver transaminase
or bilirubin
you develop heart or blood vessel problems.
ICLUSIG may be resumed at the same, or at a reduced dose, after the event is resolved
or controlled.
Your doctor may reduce your dose of ICLUSIG if your condition has responded well to
ICLUSIG.
Your doctor may recommend you discontinue ICLUSIG if your condition has not responded
to the treatment at all or you cannot tolerate the treatment.
When to take ICLUSIG
Take ICLUSIG at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
It does not matter if you take this medicine before or after food.
How to take ICLUSIG
Swallow the tablets whole with a glass of water.
Do not crush or dissolve the tablets.
How long to take it
Continue taking your medicine for as long as your doctor tells you.
It is important to keep taking your medicine even if you feel well.
Do not stop taking ICLUSIG without talking to your doctor first.
If you forget to use ICLUSIG
ICLUSIG should be used regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember, and then go back to taking your
medicine as you would normally.
If it is less than 12 hours before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
This may increase the chance of getting an unwanted side effect.
If you use too much ICLUSIG
If you think that you have used too much ICLUSIG, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using ICLUSIG?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking ICLUSIG.
Tell any other doctors, dentists and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon that you are taking this medicine.
If you become pregnant while you are taking this medicine, tell your doctor or pharmacist
immediately.
Keep all of your doctor’s appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working
and to prevent unwanted side effects. These may include:
checking your heart function and the condition of your arteries and veins
checking your blood count
measuring your serum protein known as lipase
testing your liver function
checking your blood pressure
checking for hepatitis B infection.
A Patient Alert Card (PAC) is provided in the pack with your ICLUSIG tablets and should
be carried with you at all times. The PAC provides important and readily accessible
information for your Healthcare Practitioners on important risks, their treatment
and contact details of your haematologist. If you require additional copies, please
contact the supplier whose details can be found at the end of this leaflet.
Things you should not do
Do not stop using this medicine or lower the dosage, without checking with your doctor.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Do not give this medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful driving or operating machinery until you know how ICLUSIG affects you.
This medicine may cause dizziness, tiredness, visual impairment, mental status changes,
confusion, or blurred vision in some people.
Looking after your medicine
Keep your tablets in the bottle until it is time to take them.
Store the tablets in the original container to protect from light.
Keep the medicine in a cool, dry place where the temperature stays below 30°C.
Do not store it or any other medicine in the bathroom, near a sink, or on a windowsill.
Do not leave it in the car.
Heat and dampness can destroy some medicines.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If your doctor or pharmacist tells you to stop taking this medicine, or the medicine
has passed its expiry date, ask your pharmacist what to do with any that are left
over.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Less serious side effects
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Less serious side effects
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What to do
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nausea, vomiting, constipation, diarrhoea
abdominal distension, discomfort, indigestion, pain
stomach acid reflux
rash, dry skin, itching, peeling of the skin, skin pain, infection of the skin
inflammation of hair follicles, hair loss
fatigue, sleeplessness, weakness
muscle spasms and pain, muscle weakness
hot flush/flushing, night sweats, increased sweating
decreased appetite, weight loss
dehydration
dry mouth, inflammation in the mouth, bleeding gums
pins and needles, tingling or burning sensation in feet, legs, hands or arms
inability to develop or maintain an erection.
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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sudden severe headache
eye or sight changes (blurred vision, loss of vision, dry eye, eye pain)
eyelid or face swelling, conjunctivitis
changes in speech or difficulty talking
dizziness or feeling faint
decreased alertness, lethargy or confusion
chest pain or pressure
pain in your arms, legs, back, neck or jaw
changes in heart rate (abnormally slow, fast, or irregular heart rate), bruise or
blood clot
breathing difficulties (shortness of breath, cough, rapid breathing)
weakness on one side of the body
numbness or loss of fine motor skills
trouble talking
unusual bleeding, including blood in your stool/bowel motions or dark or tarry stool,
vomiting blood, bruising easily, nose bleeding
fever in association with other signs of infection, chills
yellow skin and/or eyes
severe stomach area pain, swelling due to build-up of fluid around the stomach
dark-coloured urine
swelling of the leg, ankle or foot.
painful rash, blistering, and mouth sores
signs of Posterior Reversible Encephalopathy Syndrome (PRES): ICLUSIG may trigger
a condition called PRES. Call your healthcare provider right away if you experience
headaches, seizures, confusion, changes in vision, problems thinking
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Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side affects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ICLUSIG contains
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Active ingredient
(main ingredient)
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Ponatinib hydrochloride
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Other ingredients
(inactive ingredients)
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lactose
microcrystalline cellulose
sodium starch glycollate
silica - colloidal anhydrous
magnesium stearate
talc
Macrogol 4000
poly vinyl alcohol
titanium dioxide
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Potential allergens
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ICLUSIG does not contain gluten, sucrose, tartrazine or any other azo dyes.
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Do not take this medicine if you are allergic to any of these ingredients.
What ICLUSIG looks like
ICLUSIG 10 mg (AUST R 374484): white to off-white, biconvex, oval film-coated tablet,
marked with "NZ" on one side. Available in bottles of 30 tablets.
ICLUSIG 15 mg (AUST R 212583): white, round film-coated tablet, marked "A5" on one
side. Available in bottles of 36 or 60 tablets.
ICLUSIG 30 mg (AUST R 374492): white, biconvex, round film-coated tablet, marked with
"C7" on one side. Available in bottles of 30 tablets.
ICLUSIG 45 mg (AUST R 212584): white, round film-coated tablet, marked "AP4" on one
side. Available in bottles of 30 tablets.
Not all strengths may be marketed.
Who distributes ICLUSIG
Takeda Pharmaceuticals
Australia Pty Ltd
Level 39, 225 George Street
Sydney NSW 2000
Australia
Phone: 1800 012 612
This leaflet was prepared in September 2022.
ICLUSIG® and the ICLUSIG Logo® are registered trademarks of Ariad Pharmaceuticals, Inc. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited.