Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Deferasirox Juno. 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 receiving Deferasirox Juno against the benefits this medicine is expected to have for you.
If you have any concerns about being given Deferasirox Juno, ask your doctor.
Keep this leaflet. You may need to read it again.
What Deferasirox Juno is used for
Deferasirox Juno is used to treat a condition called iron overload, which happens when the body has too much iron. This can occur after repeated blood transfusions.
The body has no natural way to remove excess iron which comes with blood transfusions. Deferasirox Juno is also used to treat patients who have iron overload associated with their thalassemia syndromes, but who are not transfusion dependent. In patients with non-transfusion-dependent thalassemia syndromes, iron overload may develop over time due to increased absorption of dietary iron in response to low blood cell counts. Over time, this excess iron can damage important organs such as the liver and heart.
Deferasirox Juno attaches itself to the iron molecules to remove the excess iron from the body. This will help prevent iron-induced organ damage.
Deferasirox Juno is to be taken every day. This type of medicine must be taken every day to help remove the excess iron from your body.
Your doctor may have prescribed Deferasirox Juno for another reason.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
This medicine is available only with a doctor’s prescription.
Before you take Deferasirox Juno
When you must not take it:
Do not take Deferasirox Juno tablets if you have an allergy to deferasirox, the active ingredient, or to any of the other ingredients 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.
If you develop a severe rash, or experience difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction) STOP taking Deferasirox Juno immediately and tell your doctor straight away.
Do not take this medicine if you have severe kidney problems.
Do not take this medicine if you have low platelet counts. Platelets are important as they help your blood to clot. Signs of low platelets are bruising easily, prolonged bleeding from cuts, pinpoint bleeding in the skin that looks like a rash, bleeding from your gums or nose, blood in urine or stool or tiredness. Low platelet counts can be confirmed by a blood test.
Do not take this medicine if you have an advanced stage of myelodysplastic syndrome (MDS) or advanced cancer.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. In that case, return it to your pharmacist.
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 a low level of platelets in your blood test. Platelets are important as they help your blood to clot. Signs of low platelets are bruising easily, prolonged bleeding from cuts, pinpoint bleeding in the skin that looks like a rash, bleeding from your gums or nose, blood in urine or stool or tiredness.
Tell your doctor if you have or have had any problems with your kidneys or liver. Your doctor may want to take special precautions in this case.
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.
Tell your doctor if you have an intolerance to lactose. This medicine contains lactose.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop.
Some medicines and Deferasirox Juno may interfere with each other. These include:
- ciclosporin, used in transplantation to prevent organ rejection or to treat rheumatoid arthritis or atopic dermatitis
- midazolam (an injected medicine used for sedation)
- simvastatin (medicines used to lower cholesterol)
- hormonal contraceptive agents (birth control medicines). Their effectiveness may be reduced while taking Deferasirox Juno.
- certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids)
- oral bisphosphonates (medicines used to treat osteoporosis)
- anticoagulant medicines (medicines used to prevent or treat blood clotting)
- antacid preparations containing aluminium, which should not be taken at the same time of day as Deferasirox Juno
- a medicine for type 2 diabetes called repaglinide
- certain medicines for epilepsy or sedation (phenytoin, phenobarbitone)
- a medicine for HIV called ritonavir
- a medicine for tuberculosis called rifampicin
- a medicine for cancer called paclitaxel
- a medicine used to remove bile acids called cholestyramine
- theophylline (used to treat respiratory diseases such as asthma)
- busulfan (used as treatment prior to bone marrow transplant).
Other medicines that are processed like theophylline in the body and your doctor should know about include: clozapine, imipramine, haloperidol, fluvoxamine, mexiletine, naproxen, olanzapine, riluzole, and zolmitriptan.
Your doctor may need to test the level of some of these medicines in your blood. Your doctor will take these tests into consideration when deciding on the most suitable dose of these medicines for you. You may need to take different medicines. Your doctor and pharmacist have more information.
If you have not told your doctor about any of these things, tell them before you start taking this medicine.
How to take Deferasirox Juno
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 on the label, ask your doctor or pharmacist for help.
How much to take
The dose is related to body weight for all patients. Your doctor will calculate the dose you need and tell you how many tablets to take each day.
The usual starting dose is 20 mg per kilogram body weight each day for patients receiving regular blood transfusions.
For patients NOT receiving regular blood transfusions, the usual starting dose is 10 mg per kilogram body weight.
A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
Depending on your response, your doctor may increase the dose to a maximum 40 mg per kilogram body weight each day if you receive regular blood transfusions or 20 mg per kilogram body weight if you are NOT receiving regular blood transfusions.
How to take it
Disperse the required number of tablets completely by stirring in a 100 – 200 mL glass of water or orange juice or apple juice until a suspension forms. When dispersing in juice, it helps to first disperse the tablets in about two tablespoons of water, before diluting with juice.
Drink the entire contents of the glass, then add a little water or juice to what is left in the empty glass and drink that too.
Do not disperse the tablets in fizzy drinks or milk.
Do not chew, split or crush the tablets. Do not swallow them whole.
When to take it
Take Deferasirox Juno once a day, every day, at about the same time each day. Take it on an empty stomach at least 30 minutes before eating any food. Taking it at the same time each day, 30 minutes before eating food will have the best effect. It will also help you remember when to take it.
How long to take it
Do not stop taking Deferasirox Juno unless your doctor tells you to – even if you feel well. This medicine helps to control your condition, but does not cure it. Therefore, you must take it every day. Continue taking the medicine as long as your doctor tells you to.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take the next dose when you are meant to.
Otherwise, take it as soon as you remember, and then go back to taking it 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 you getting an unwanted side effect.
If you have trouble remembering to take your medicine, ask your pharmacist for some hints.
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 Deferasirox Juno. Do this even if there are no signs of discomfort or poisoning. Keep the telephone numbers for these places handy. You may experience nausea, vomiting, headache, diarrhoea, or kidney or liver problems if you have taken too much Deferasirox Juno.
While you are taking Deferasirox Juno
Things you must do
If you notice substantially reduced urine output, tell your doctor straight away. This could be a sign of a problem with your kidneys.
Elderly patients should be monitored closely by their doctor. Elderly patients may experience more side effects than younger patients and their doctor may adjust their dose.
Keep all of your doctor’s appointments so that your progress can be checked. Your doctor will do regular tests (blood, urine or Magnetic Resonance Imaging (MRI)) to make sure the medicine is working and to prevent unwanted side effects. Your doctor will also use these tests to decide when you should stop taking Deferasirox Juno. Your eyesight and hearing may be tested during treatment as a precautionary measure.
If you become pregnant while taking this medicine, tell your doctor immediately. It may affect your developing baby. Your doctor will discuss the risks and benefits of continuing treatment in this case.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
Things you must not do
Do not give this medicine to anyone else, even if their condition seems similar to yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Things to be careful of:
Be careful driving, operating machinery or doing jobs that require you to be alert until you know how Deferasirox Juno affects you. This medicine may cause dizziness in some people. If you experience dizziness, do not drive, operate machinery or do anything else that could be dangerous. Children should be careful when riding bicycles or climbing trees.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Deferasirox Juno even if you do not think it is connected with the medicine. All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.
Elderly patients may experience more side effects than younger patients.
Do not be alarmed by the following lists of side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.
STOP taking Deferasirox Juno and seek medical help immediately if you or your child experience any of the following symptoms which may be signs of an allergic reaction:
- difficulty in breathing and swallowing
- swelling of the face, lips, tongue or throat
- severe itching of the skin, with a red rash or raised bumps
STOP taking Deferasirox Juno and tell your doctor immediately if you notice any of the following:
- rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms and enlarged lymph nodes (signs of severe skin reaction)
- a substantially reduced urine output (sign of kidney problem)
- drowsiness, upper right abdominal pain, yellowing of your skin or eyes and dark urine (sign of liver problems)
- vomiting with blood and/or black, tar-like stools
- frequent heartburn or abdominal pain (ulcers), particularly after eating or taking the drug
- blurred, cloudy or partial loss of vision
- hearing disturbances
- sudden back pain or pain on the right side of the abdomen (signs of gallstones)
- severe upper stomach pain (pancreatitis)
- pain in the upper abdomen, indigestion, loss of appetite, feeling full and bloated, not being able to tolerate fatty foods, nausea or weight loss (may be a sign of ulcer bleeding or haemorrhage)
The above list includes serious side effects which may require medical attention. These side effects do not occur frequently.
Tell your doctor or pharmacist if you notice any of the following and they worry you:
- nausea, diarrhoea, vomiting, pain in the abdomen, bloating, constipation or indigestion
- fever or symptoms of a cold or flu
- cough or sore throat
- swelling of arms or legs
- change in the colour of the skin
- trouble sleeping
- sore muscles or joints
- hair loss
The above list includes the more common side effects of your medicine. They are usually mild and short-lived.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell. Some people may have other side effects not yet known or mentioned in this leaflet. Some of these side effects, for example, changes in kidney and liver function, can only be found when your doctor does tests from time to time to check your progress.
After using Deferasirox Juno
- Keep your medicine in the original container until it is time to take it.
- Store it in a cool, dry place, below 25°C
- Do not store this medicine or any other medicine in the bathroom or near a sink
- Do not leave it in the car or on window sills.
Keep the medicine 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 tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine you have left over.
What it looks like
Deferasirox Juno tablets are white to off white, round, flat, uncoated tablets, with debossing “D” on one side and “125”, “250” or “500” on the other side.
Deferasirox Juno tablets are packaged in blister packs made from PVC/PE/PVDC backed with aluminium foil.
- microcrystalline cellulose
- lactose monohydrate
- croscarmellose sodium
- sodium lauryl sulfate
- colloidal anhydrous silica
- magnesium stearate
Deferasirox Juno is sponsored in Australia by:
42 Kelso Street,
VIC – 3121
Australian Registration Numbers
Deferasirox Juno 125 mg: 306559
Deferasirox Juno 250 mg: 306558
Deferasirox Juno 500 mg: 306557
This leaflet was revised in July 2021.
Published by MIMS September 2021