When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to deferasirox.

How to Use This Medicine:
Tablet, Tablet for Suspension

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Tablet:
  
  • Swallow the tablet whole with water or other liquid.
  • Take the tablet at the same time each day on an empty stomach or with a light meal.
  • If you have trouble swallowing the whole tablet, it may be crushed and mixed with soft foods (such as apple sauce or yogurt) immediately before taking it orally.
• Tablet for suspension:
  
  • Dissolve the tablet in water, orange juice, or apple juice. Mix well and drink the mixture right away. To make sure you get all of the medicine, add more liquid to the glass, and then drink all of this liquid too. Do not chew or swallow the tablet.
  • Take the medicine at the same time each day on an empty stomach, at least 30 minutes before you eat.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not take antacids that contain aluminum while you are using this medicine.
• There are many medicines that can interact with deferasirox. Make sure your doctor knows the names of all the medicines you use, especially the following:
  
  • Birth control pills or patches
  • Bisphosphonate medicine
  • Blood thinner (including warfarin)
  • Coffee or products that contain caffeine
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)
  • Steroid medicine (including budesonide, fluticasone, prednisolone, prednisone)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, blood or bone marrow problems (such as myelodysplastic syndrome, low platelet counts), cancer, eye problems (such as cataracts, glaucoma), hearing problems, or stomach or bowel problems (such as ulcers or bleeding).
• This medicine can cause the following problems:
  
  • Kidney problems, including kidney failure
  • Liver problems
  • Stomach or bowel bleeding (may be life-threatening)
  • Anemia or other problems with blood cell counts
  • Serious skin reactions
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine may make you dizzy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash
• Bloody or black, tarry stools, severe stomach pain, vomiting of blood or material that looks like coffee grounds
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Decrease in how much or how often you urinate, bloody or cloudy urine
• Fever, chills, cough, sore throat, and body aches
• Rapid weight gain, swelling in your face, hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Hearing problems or loss of hearing
• Mild nausea, vomiting, diarrhea, stomach pain
• Mild rash
• Vision changes, eye pain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088