ICLUSIG CMI VERSION V2
Ponatinib (pon-a-tin-ib) hydrochloride
Consumer Medicine Information (CMI)
Important Safety Information
Iclusig can cause serious side effects, including:
Blood clots or blockage in your blood vessels
These may lead to a heart attack, stroke, vision loss, or death. A blood clot or blockage in blood vessels can prevent proper blood flow to your heart, brain, bowels, legs, eyes, don’t take levaquin
and other parts of your body (sometimes resulting in amputation). You may need emergency surgery or treatment in a hospital.
Blood clots or blockage in blood vessels can happen in people with or without risk factors for heart and blood vessel disease, including people 50 years of age or younger.
Iclusig can cause heart problems, including heart failure, which can be serious and may lead to death. Irregular slow or fast heartbeats and heart attack may also occur. Your risk for these problems will be checked by your doctor before and during treatment with Iclusig.
Increased Blood Pressure
Iclusig can cause an increase in blood pressure, which can be serious and may lead to organ damage. This can happen at any time during treatment, in people with or without risk for high blood pressure, and may contribute to the risk of blood clots or blockage in blood vessels. Your blood pressure should be checked regularly and managed by your doctor.
Iclusig can cause liver problems, including liver failure, which can be severe and may lead to death. Your doctor will do blood tests before and during your treatment with Iclusig to check for liver problems.
Get medical help right away if you get any of the following symptoms:
chest pain or pressure
pain in your arms, legs, back, neck or jaw
shortness of breath
numbness or weakness on one side of your body
severe stomach area pain
decreased vision or loss of vision
fast or irregular heartbeats
dizziness or feel faint
swelling of your legs
yellowing of your skin or the white part of your eyes (jaundice)
dark “tea-coloured” urine
loss of appetite
bleeding or bruising
It is important to tell your doctor if you have any of the symptoms described above.
What is in this leaflet
This leaflet answers some common questions about Iclusig.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
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 https://www.ebs.tga.gov.au/.
Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine.
You may need to read it again.
What Iclusig is used for
This medicine 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 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.
This medicine is only available with a prescription from a doctor experienced with leukaemia treatment.
Ask your doctor if you have any questions about why it has been prescribed for you.
This medicine is not addictive.
Before you take Iclusig
When you must not take it
Do not take Iclusig if you have an allergy to:
any medicine containing ponatinib
any of the ingredients listed at the end of this leaflet
Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing.
Do not take it after the expiry date printed on the bottle or if the packaging is damaged or shows signs of tampering.
If it has expired or is damaged return it to your pharmacist for disposal.
Before you start to take it
Tell your doctor if you have any allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
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
liver or kidney problems
a pancreas disorder
a history of alcohol abuse
Tell your doctor if you are pregnant, intending to get 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food store.
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, aluminium, 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
Your doctor or pharmacist has more information on medicines to be careful with or to avoid while taking Iclusig.
How to take 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:
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.
How to take it
Swallow the tablets whole with a glass of water.
Do not crush or dissolve the tablets.
When to take it
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 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 take it
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.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed.
This may increase the chance of getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you take too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at your nearest hospital, if you think you or anyone else may have taken too much Iclusig. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.
While you are taking Iclusig
Things you must 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 must not do
Do not stop taking Iclusig, 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.
Things to be careful of
Be careful driving or operating machinery until you know how Iclusig affects you.
This medicine may cause dizziness, tiredness, or blurred vision in some people.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Iclusig.
It helps most people with leukaemia, but it may have unwanted side effects in a few people. All medicines may have some unwanted side effects. Sometimes they are serious, but most of the time they are not. You may need medical attention if you get some of the side-effects.
If you are over 65 years of age you may have an increased chance of getting side effects.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following and they worry you:
nausea, vomiting, constipation, diarrhoea
abdominal distension, discomfort, indigestion, pain
stomach acid reflux
rash, dry skin, itching, peeling of the skin, skin pain
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
dry mouth, inflammation in the mouth
pins and needles, tingling or burning sensation in feet, legs, hands or arms
inability to develop or maintain an erection.
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
sudden severe headache
eye or sight changes (blurred vision, loss of vision, dry eye, eye pain)
eyelid or face swelling
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)
breathing difficulties (shortness of breath, cough, rapid breathing)
weakness on one side of the body
numbness or loss of fine motor skills
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 of the leg, ankle or foot.
painful rash, blistering, skin peeling, 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
The above list includes very serious side effects. You may need urgent medical attention.
This is not a complete list of side effects.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some people.
After taking Iclusig
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 children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
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.
What it looks like
Iclusig comes in two types of tablets:
Iclusig 15 mg – white, round film-coated tablets, marked “A5” on one side.
Iclusig 45 mg – white, round film-coated tablets, marked “AP4” on one side.
The 15 mg strength is available in bottles of 30 or 60 tablets.
The 45 mg strength is available in bottles of 30 tablets.
Each Iclusig tablet contains 15 or 45 mg of ponatinib hydrochloride as the active ingredient:
The tablets also contain
sodium starch glycollate
silica – colloidal anhydrous
poly vinyl alcohol
Iclusig does not contain gluten, sucrose, tartrazine or any other azo dyes.
Australia Pty Ltd
225 George Street
Sydney NSW 2000
Phone: 1800 012 612
Australian Registration Number(s)
15 mg tablets: AUST R 212583
45 mg tablets: AUST R 212584
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.
This leaflet was prepared in August 2020.