Deferasirox

Deferasirox is used for:

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Treating high levels of iron in the blood caused by blood transfusions.

Deferasirox is an iron chelating agent. It works by binding to the extra iron in the blood and removing it from the body.

Do NOT use Deferasirox if:

• you are allergic to any ingredient in Deferasirox
• you are taking other iron chelating medicines (eg, deferoxamine)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Deferasirox :

Some medical conditions may interact with Deferasirox . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of kidney or liver problems, blood or bone marrow problems, vision problems, or hearing problems

Some MEDICINES MAY INTERACT with Deferasirox . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Other iron chelating medicines (eg, deferoxamine) because they may increase the risk of Deferasirox 's side effects.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Deferasirox may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Deferasirox :

Use Deferasirox as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Deferasirox by mouth on an empty stomach at least 30 minutes before food.
• Do not chew or swallow the tablet whole. You must mix Deferasirox with water, orange juice, or apple juice before you take it. Ask your doctor or pharmacist how much fluid you should use to mix your dose of Deferasirox .
• To mix Deferasirox , place the tablet in the correct amount of water, orange juice, or apple juice. Stir well until the tablet has completely dissolved, then drink all of the liquid. Rinse the container with an additional small amount of water, orange juice, or apple juice and drink the contents to ensure the entire dose is taken.
• Take Deferasirox on a regular schedule to get the most benefit from it. Taking it at the same time each day will help you remember to take it.
• Do not take an antacid that has aluminum in it at the same time you take Deferasirox . If you take antacids that contain aluminum, ask your doctor or pharmacist how to take it with Deferasirox .
• If you miss a dose of Deferasirox , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Deferasirox .

Important safety information:

• Deferasirox may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Deferasirox with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
• Lab tests, including liver and kidney function, serum ferritin levels, vision tests, hearing tests, and blood counts, may be performed while you use this medicine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Deferasirox with caution in the ELDERLY; they may be more sensitive to its effects.
• Deferasirox should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Deferasirox while you are pregnant. It is not known if Deferasirox is found in breast milk. If you are or will be breast-feeding while you use Deferasirox , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Deferasirox :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; headache; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chills; decreased amount of urine; decreased hearing or other hearing problems; fever; pale stools; persistent sore throat or cough; severe or persistent vomiting or diarrhea; stomach pain; unusual bruising or bleeding; unusual tiredness or fatigue; vision changes; yellowing of skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include nausea and diarrhea.

Store Deferasirox at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Deferasirox out of the reach of children and away from pets.

General information:

• If you have any questions about Deferasirox , please talk with your doctor, pharmacist, or other health care provider.
• Deferasirox is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Deferasirox . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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