Jadenu binds to iron and removes it from the bloodstream.

Jadenu is usded in people 2 years of age and older who have an increased amount of iron in their blood for a long period of time (chronic), caused by repeated blood transfusions.

Jadenu is also used in certain people 10 years of age or older with thalassemia who have an increased amount of iron in their blood but who are not receiving regular blood transfusions.

It is not known if Jadenu is safe and effective when used with other medicines to treat an increased amount of iron in the blood.

You should not use Jadenu 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. Call your doctor at once if you have swelling, shortness of breath, pain in your upper stomach, loss of appetite, little or no urinating, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Jadenu 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.

Before taking this medicine

You should not use Jadenu 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.

To make sure Jadenu is safe for you, 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.

Jadenu 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 Jadenu.

Take Jadenu 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 Jadenu.

Take Jadenu at the same time every day.

You may take this medicine 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 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.

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 Jadenu 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.

To make sure Jadenu is safe for you, 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.

Jadenu 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 Jadenu.

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.

Jadenu 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 Jadenu (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 Jadenu 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 Jadenu 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.