Jadenu Sprinkle

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.

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.

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.

In the U.S.

• Exjade
• Jadenu
• Jadenu Sprinkle

Available Dosage Forms:

• Tablet for Suspension
• Tablet
• Granule

Therapeutic Class: Heavy Metal Chelator

Deferasirox is used to remove excess iron from the body in patients who had too many blood transfusions and in patients with non-transfusion dependent thalassemia syndromes.

Deferasirox combines with iron in the blood. The combination of iron and deferasirox is then removed from the body by the kidneys. If you have too much iron in the body, it can damage various organs and tissues.

This medicine is available only with your doctor's prescription.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Diarrhea
• dizziness
• earache or pain in the ear
• nausea
• stomach pain
• voice changes
• vomiting

• Blindness
• blurred vision
• change in hearing
• change in vision
• pain or discomfort in the eye

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• dark-colored urine
• decrease in the amount of urine
• general feeling of tiredness or weakness
• hives, welts, skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• lower back or side pain
• pale skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness, soreness, itching of the skin
• sores, blisters
• stomach pain, continuing
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• vomiting of blood or material that looks like coffee grounds
• yellow eyes or skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.