Exjade binds to iron and removes it from the bloodstream.

Exjade is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.

Exjade is also used to treat chronic iron overload syndrome caused by a genetic blood disorder (non-transfusion-dependent thalassemia) in adults and children who are at least 10 years old.

You should not use Exjade if you have severe kidney or liver disease, advanced cancer, a blood cell or bone marrow disorder, or low levels of platelets in your blood.

Exjade can harm your liver or kidneys. Call your doctor at once if you have swelling, rapid weight gain, shortness of breath, pain in your upper stomach, loss of appetite, pain in your side or lower back, little or no urinating, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Exjade may also cause stomach or intestinal bleeding. Call your doctor at once if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

While you are taking deferasirox, do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Take Exjade exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor may perform certain tests to make sure you do not have conditions that would prevent you from safely using Exjade.

Take this medicine at the same time every day.

Take Exjade on an empty stomach at least 30 minutes before eating.

Do not chew or crush the Exjade dispersible tablet, and do not swallow it whole. Place the tablet into a glass of apple juice, orange juice, or water and allow the tablet to disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To make sure you get the entire dose, add a little more liquid to the same glass, swirl gently and drink right away.

If you take less than 1000 milligrams (1 gram) daily, dissolve the dispersible tablet in about one-half cup of apple juice, orange juice, or water. If you take more than 1000 milligrams daily, dissolve the tablet in about 1 cup of apple juice, orange juice, or water.

You may need frequent blood tests. Your kidney or liver function may also need to be checked every 6 months, and you may need a liver biopsy.

Store at room temperature, away from moisture and heat.

You should not use Exjade if you are allergic to deferasirox, or if you have:

• severe liver or kidney disease;

• advanced cancer;

• a bone marrow disorder; or

• low levels of platelets in your blood.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• anemia (low red blood cells);

• cancer (especially blood cell cancer such as leukemia);

• a stomach ulcer;

• stomach or intestinal bleeding;

• vision or hearing problems; or

• a weak immune system caused by disease (such as cancer, HIV, or AIDS), or by receiving steroids, chemotherapy, or radiation.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Exjade can make birth control pills less effective. Ask your doctor about using non hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

You should not breast-feed while you are taking deferasirox.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use other iron-chelating medicines such as deferoxamine (Desferal), unless your doctor has told you to.

Do not take antacids that contain aluminum, such as Amphojel, Gaviscon, Maalox, Mi-Acid, Mylanta, Rulox, and others.

Deferasirox may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have signs of an allergic reaction to Exjade (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Stop using Exjade and call your doctor at once if you have:

• problems with vision or hearing;

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• low blood cell counts - fever, chills, mouth sores, skin sores, pale skin, easy bruising, unusual bleeding, cold hands and feet, feeling light-headed or short of breath; or

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Serious side effects may be more likely in older adults.

Common Exjade side effects may include:

• nausea, vomiting, stomach pain;

• diarrhea; or

• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with deferasirox. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.