Deferasirox (By mouth)

How to Use This Medicine

Tablet for Suspension

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine at the same time each day on an empty stomach, at least 30 minutes before you eat.
• Dissolve the tablet for suspension in water, orange juice, or apple juice, mix well, then drink the mixture right away. To make sure you get all of the medicine, add some more liquid to the drinking glass, then drink all of this liquid too. Do not chew or swallow the tablet whole, and do not use it without mixing it in liquid first.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Introduction

Deferasirox (dee-FER-a-sir-ox)

Treats iron toxicity (too much iron in the blood). This medicine is an iron chelator (binder).

Brand Name(s)

Exjade

When This Medicine Should Not Be Used

Drugs and Foods to Avoid

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

• You should not take this medicine at the same time as antacids that contain aluminum, such as Maalox® or Mylanta®. Make sure your doctor knows if you are using any other iron binding medicine such as deferoxamine (Desferal®).
• Make sure your doctor knows if you are using cholestyramine (Questran®), cyclosporine (Gengraf®, Neoral®, or Sandimmune®), midazolam (Versed®), paclitaxel (Taxol®), phenobarbital (Luminal®), phenytoin (Dilantin®), repaglinide (Prandin®), rifampicin (Rifadin®, Rimactane®), ritonavir (Norvir®), simvastatin (Zocor®), or birth control pills. Tell your doctor if you are using cyclobenzaprine (Flexeril®), fluvoxamine (Luvox®), haloperidol (Haldol®), imipramine (Tofranil®), mexiletine (Mexitil®), olanzapine (Zyprexa®), theophylline (Theo-Dur®), tizanidine (Zanaflex®), zileuton (Zyflo®), or zolmitriptan (Zomig®).
• Tell your doctor if you are also using pain or arthritis medicine called "NSAID" (such as aspirin, celecoxib, ibuprofen, Aleve®, Celebrex®, or Motrin®), a steroid medicine (such as dexamethasone, prednisolone, prednisone, or Medrol®), medicine to treat bone diseases or a bisphosphonate medicine (such as alendronate, etidronate, tiludronate, Didronel®, Fosamax®, or Skelid®), or a blood thinner (such as warfarin, Coumadin®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, eye problems (such as cataracts, glaucoma), hearing problems, or stomach or bowel problems (such as ulcers or bleeding).
• This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
• Stop using this medicine and check with your doctor right away if you or your child have the following symptoms: agitation, confusion, decreased urine output, lethargy, muscle twitching, rapid weight gain, seizures, or swelling of the face, ankles, or hands. These may be symptoms of a serious kidney problem.
• Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you or your child are having more than one of these symptoms: abdominal or stomach pain or tenderness; clay-colored stools; dark urine; fever; nausea and vomiting; skin rash; or yellow eyes or skin.
• Check with your doctor right away if you or your child have these symptoms: abdominal or stomach pain, cramping, or burning; black, tarry stools; constipation; diarrhea; heartburn; indigestion; nausea; or vomiting of blood or material that looks like coffee grounds. These may be symptoms of a serious stomach or bowel problem.
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; sores or ulcers on the skin; or fever or chills while you or your child are using this medicine.
• Very rarely, this medicine might cause problems with your vision or hearing. Your doctor might want to check your eyes and ears before you begin using this medicine, and once a year after that. Tell your doctor right away if you start having trouble seeing or hearing while you or your child are using this medicine.
• If you or your child have diarrhea or vomiting, drink plenty of water or fluids to keep your body hydrated.
• This medicine may make you dizzy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Your doctor will need to check your blood or urine at regular visits while you are using this medicine. Be sure to keep all appointments.

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.
• Dark-colored urine or pale stools.
• Decrease in how much or how often you urinate.
• Fever, chills, cough, sore throat, and body aches.
• Rapid weight gain.
• Red or black stools.
• Severe nausea, vomiting, diarrhea, or stomach pain.
• Severe rash.
• Swelling in your face, hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Vomiting of blood or material that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

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

• Blurred vision or changes in vision.
• Cough.
• Headache.
• Hearing problems or loss of hearing.
• Mild nausea, vomiting, diarrhea, or stomach pain.
• Mild rash.

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