- Brand name
- Iclusig Tablets
- Active ingredient
Consumer medicine information (CMI) leaflet
Please read this leaflet carefully before you start using Iclusig Tablets.Download CMI (PDF) Download large text CMI (PDF)
What Is In This Leaflet
This leaflet answers some common questions about ICLUSIG tablets.
It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking ICLUSIG 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 want 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.
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.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine is only available with a prescription from a doctor experienced with leukaemia treatment.
There is no evidence that this medicine is addictive.
Before You Take ICLUSIG
When you must not take it
Do not take this medicine if you have an allergy to:
- any of the other ingredients of this medicine, listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may include:
- shortness of breath
- wheezing or difficulty breathing
- swelling of the face, lips, tongue or other parts of the body
- rash, itching or hives on the skin.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.
Before you start to take it
Tell your doctor if you have 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, including heart failure, irregular heartbeats, and QT prolongation
- a prior heart attack or stroke
- high blood pressure
- a history of high cholesterol
- bleeding problems
- a liver disorder
- a pancreas disorder
- a history of alcohol abuse
- a hepatitis B infection
Your doctor may want to take additional precautions.
Tell your doctor if you:
- Are pregnant or plan to become pregnant
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.
Effective contraception must be used during treatment.
Only use ICLUSIG during pregnancy if your doctor tells you it is absolutely necessary.
Your doctor can discuss with you the risks and benefits involved.
- Are breastfeeding or plan to breastfeed
Stop breast-feeding during treatment with ICLUSIG. It is not known if ICLUSIG passes into breast milk.
- Are lactose intolerant
ICLUSIG contains lactose.
Your doctor will perform the following checks periodically:
- evaluations of your heart function and the condition of your arteries and veins
- a complete blood count
- checks of the serum protein known as lipase
- liver tests
- blood pressure
- test for hepatitis B infection.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Drugs that may interact with ICLUSIG 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 certain 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 elevated cholesterol levels
- methotrexate: a medicine used to treat severe joint inflammation (rheumatoid arthritis), cancer and the skin disease psoriasis
- sulfasalazine: a medicine used to treat severe bowel and rheumatic joint inflammation.
ICLUSIG may be taken with or without food.
Grapefruit products such as grapefruit juice, or Seville orange-based products such as marmalade should not be consumed because of a possible interaction with ICLUSIG.
How To Take ICLUSIG
ICLUSIG therapy should 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.
Treatment with ICLUSIG may be postponed or stopped immediately by your doctor.
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:
- pancreas inflammation
- increased levels of the serum protein lipase or amylase
- you develop heart or blood vessel problems.
ICLUSIG use may be resumed at the same, or at a reduced dose, after the event is resolved or controlled.
Your doctor may reduce your dose 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. The tablets can be taken with or without food. Do not crush or dissolve the tablets.
How long to take it
Take your medicine 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.
Make sure you take ICLUSIG daily for as long as it is prescribed. This is a long-term treatment.
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 a forgotten dose.
Take your next dose at your regular time.
If you are not sure what to do, ask your doctor or pharmacist.
Do not stop taking ICLUSIG without your doctor’s permission.
If you take too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that 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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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 become pregnant while taking this medicine, tell your doctor immediately.
Things you must not do
Do not stop taking your medicine or lower the dosage without checking with your doctor.
Do not take ICLUSIG 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.
Do not drink grapefruit juice or eat Seville orange-based products, eg. marmalade, while taking ICLUSIG.
If you experience side effects that impair your vision or balance, your ability to drive a car or operate machinery could be impaired.
All medicines may have some unwanted side effects. Sometimes they are serious, most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.
Do not be alarmed by the following lists of side effects.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ICLUSIG.
If you are over 65 years of age you may have an increased chance of getting side effects.
You may need medical attention if you get some of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following side effects 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.
Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you get any of the following side effects:
- 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
- trouble talking
- unusual bleeding, including blood in stool, vomiting blood, dark or tarry stool, easy bruising, nose bleeding
- fever in association with other signs of infection, chills
- yellow skin and eyes
- severe stomach area pain
- dark-coloured urine
- swelling of the leg, ankle or foot.
Tell your doctor or pharmacist if you notice anything else that is making you feel unwell.
Other side effects not listed above may also occur in some people.
This is not a complete list of side effects. For any unexpected effects while taking ICLUSIG, contact your doctor or pharmacist immediately.
After Using ICLUSIG
Do not use this medicine after the expiry date, which is stated on the bottle label after EXP.
The expiry date refers to the last day of that month.
Keep your medicine in a cool dry place where the temperature stays below 30°C. Store in the original container to protect from light.
Do not store ICLUSIG or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or 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 (about 5 feet) above the ground is a good place to store medicines.
If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.
What it looks like
ICLUSIG 15 mg and 45 mg are white, round tablets. The 15 mg tablet is marked with “A5” on one side of the tablet. The 45 mg tablet is marked with “AP4” on one side of the tablet.
The 15 mg tablets are available in bottles of 30 or 60.
The 45 mg tablets are available in bottles of 30.
- ponatinib hydrochloride (as ponatinib)
Inactive ingredients (tablet core and film coating):
- microcrystalline cellulose
- sodium starch glycollate (Type B)
- silica - colloidal anhydrous
- magnesium stearate
- Macrogol 4000
- poly vinyl alcohol
- titanium dioxide
This medicine contains lactose.
This medicine does not contain sucrose, gluten, tartrazine or any other azo dyes.
ARIAD Pharmaceuticals (Australia) Pty Ltd
Level 1, 711 High Street
Kew East, Victoria, 3102
Specialised Therapeutics Australia Pty Ltd
Ph: 1300 798 820
Fax: 1800 798 829
Australian Register Number
15 mg film-coated tablet (bottle): AUST R 212583
45 mg film-coated tablet (bottle): AUST R 212584
This leaflet was prepared by ARIAD Pharmaceuticals (Australia) Pty Ltd
Last revised: June 2016