Uses of Deferasirox Tablets:

• It is used to get rid of iron when too much is in the body.

What do I need to tell my doctor BEFORE I take Deferasirox Tablets?

• If you have an allergy to deferasirox or any other part of this medicine (deferasirox tablets).
• If you are allergic to this medicine (deferasirox tablets); any part of this medicine (deferasirox tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Cancer, certain blood or bone marrow problems (low platelets, high-risk myelodysplastic syndrome/MDS), kidney disease, or liver disease.
• If you have not been able to eat or drink like normal, you have diarrhea, you are throwing up, or you get another illness that can cause dehydration.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.
• If you are taking any of these drugs: Cholestyramine, colesevelam, colestipol, phenobarbital, phenytoin, rifampicin, ritonavir, theophylline, or tizanidine.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine (deferasirox tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (deferasirox tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Deferasirox Tablets?

For all patients taking this medicine (deferasirox tablets):

• Tell all of your health care providers that you take this medicine (deferasirox tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (deferasirox tablets) affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• Have an eye exam as you have been told by your doctor.
• Have a hearing test before starting this medicine (deferasirox tablets) and while you take this medicine (deferasirox tablets).
• Do not take antacids that have aluminum in them with this medicine (deferasirox tablets).
• If you are 55 or older, use this medicine (deferasirox tablets) with care. You could have more side effects.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking this medicine (deferasirox tablets).
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (deferasirox tablets) while you are pregnant.

Children:

• If giving this medicine (deferasirox tablets) to your child and your child's weight changes, talk with the doctor. The dose of this medicine (deferasirox tablets) may need to be changed.
• Use with care in children. Talk with the doctor.

How is this medicine (Deferasirox Tablets) best taken?

Use this medicine (deferasirox tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take on an empty stomach or with a light meal.
• Take this medicine (deferasirox tablets) by mouth with water or other liquid.
• If you cannot swallow tablets, the tablet may be crushed and added to a small amount of soft food. Take the mixture right away. Do not store for future use.
• The 90 mg tablet must not be crushed using certain types of tablet crushers. If you will be crushing the 90 mg tablet, talk with the doctor or pharmacist.
• Take this medicine (deferasirox tablets) at the same time of day.
• Keep taking this medicine (deferasirox tablets) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of bowel problems like black, tarry, or bloody stools; fever; mucus in the stools; throwing up blood or throw up that looks like coffee grounds; or very bad stomach pain, constipation, or diarrhea.
• Change in hearing.
• Hearing loss.
• Change in eyesight.
• Chest pain or pressure, a fast heartbeat, or passing out.
• Swollen gland.
• Flu-like signs.
• Rashes may happen with this medicine (deferasirox tablets). This medicine may need to be stopped for some types of rashes. If you get a rash while taking this medicine (deferasirox tablets), call your doctor right away to find out what to do.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• This medicine may lower the ability of your bone marrow to make blood cells that your body needs. This can lead to very bad and sometimes deadly bleeding problems or infections. Tell your doctor right away if you have signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, a wound that will not heal; any bruising or bleeding; or if you feel very tired or weak.

What are some other side effects of Deferasirox Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Stomach pain or diarrhea.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Deferasirox Tablets?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (deferasirox tablets), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.