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Iclusig®
(eye-CLUE-sig)

Ponatinib (pon-a-tin-ib) hydrochloride


Consumer Medicine Information

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, 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.

Heart Problems
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.

Liver problems
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
  • trouble talking
  • headache
  • severe stomach area pain
  • decreased vision or loss of vision
  • fast or irregular heartbeats
  • dizziness or feel faint
  • swelling of your legs
  • confusion
  • yellowing of your skin or the white part of your eyes (jaundice)
  • dark “tea-coloured” urine
  • sleepiness
  • 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
  • diabetes
  • high cholesterol
  • bleeding problems
  • liver or kidney problems
  • a pancreas disorder
  • a history of alcohol abuse
  • hepatitis B

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:
    - 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.

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.

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.

Side effects

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
  • dehydration
  • 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
  • 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
  • dark-coloured urine
  • 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

Storage

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.

Disposal

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.

Product description

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.

Ingredients

Each Iclusig tablet contains 15 or 45 mg of ponatinib hydrochloride as the active ingredient:

The tablets also contains

  • lactose
  • microcrystalline cellulose
  • sodium starch glycollate
  • silica - colloidal anhydrous
  • magnesium stearate
  • talc
  • Macrogol 4000
  • poly vinyl alcohol
  • titanium dioxide

Iclusig does not contain gluten, sucrose, tartrazine or any other azo dyes.

Sponsor

Takeda Pharmaceuticals
Australia Pty Ltd
Level 5
2 Chifley Square
Sydney NSW 2000

Iclusig is supplied in Australia by:

Specialised Therapeutics Australia
Pty Ltd
Ph: 1300 798 820
Fax: 1800 798 829
www.stabiopharma.com

Australian Registration Number(s)

15 mg tablets: AUST R 212583

45 mg tablets: AUST R 212584

® Trademark

This leaflet was prepared in September 2018.

Version No. 1

Published by MIMS November 2018

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