deferasirox

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Pronunciation: de FER a sir ox

Brand: Exjade, Jadenu, Jadenu Sprinkle

What is the most important information I should know about deferasirox?

You should not use this medicine 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.

Deferasirox can harm your liver or kidneys. Stop using deferasirox and 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).

Deferasirox 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.

What is deferasirox?

Deferasirox binds to iron and removes it from the blood stream.

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

Deferasirox is also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old.

Deferasirox may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using deferasirox?

You should not use this medication if you are allergic to it, or if you have:

  • severe liver or kidney disease;
  • advanced cancer;
  • a bone marrow disorder; or
  • low levels of platelets in your blood.

To make sure deferasirox is safe for you, tell your doctor if you have:

  • kidney disease;
  • liver disease;
  • anemia (low red blood cells);
  • cancer (especially blood cell cancer such as leukemia);
  • a stomach ulcer;
  • a history of 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.

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

It is not known whether deferasirox passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking deferasirox.

How should I take deferasirox?

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

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine at the same time every day.

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

You may take Jadenu on an empty stomach or with a small low-fat meal.

Swallow the Jadenu tablet whole with a full glass of water. If you cannot swallow the Jadenu tablet whole, you may crush the tablet and mix it with yogurt, applesauce, or other soft food.

To take Jadenu Sprinkles, open the packet and sprinkle the medicine into a spoonful of soft food.

After mixing a crushed tablet or sprinkles with soft food, swallow the mixture right away without chewing. Do not save it for later use.

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 Exjade 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.

While using deferasirox, 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking deferasirox?

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

While you are taking deferasirox, 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.

What are the possible side effects of deferasirox?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

  • problems with vision or hearing;
  • kidney problems --urinating more or less than usual; painful or difficult urination; swelling in your feet or ankles; weakness, bone pain; 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);
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • low blood cell counts --fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Serious side effects may be more likely in older adults.

Common 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.

What other drugs will affect deferasirox?

Many other medicines can increase or decrease the effects of deferasirox. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • repaglinide, rifampin, ritonavir, theophylline;
  • cholesterol-lowering medicine --cholestyramine, colestipol, colesevelam;
  • a blood thinner --warfarin, Coumadin, Jantoven;
  • NSAIDs (nonsteroidal anti-inflammatory drugs) --aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
  • osteoporosis medicine --alendronate (Fosamax), risedronate (Actonel), and others;
  • seizure medicine --carbamazepine, phenobarbital, phenytoin; or
  • steroid medicine --prednisone, methylprednisolone, and others.

This list is not complete. Other drugs may interact with deferasirox, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about deferasirox.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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