Jadenu Sprinkle

Jadenu Sprinkle binds to iron and takes it out of the bloodstream.

Jadenu Sprinkle is used to treat iron overload that happens because of blood transfusions in adults and children who are at least 2 years old.

Jadenu Sprinkle 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.

Jadenu Sprinkle may also be used for reasons not mentioned in this medication guide.

Your doctor may do some tests to ensure you do not have any conditions that would make using Jadenu Sprinkle unsafe.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Jadenu Sprinkle 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 onto 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 let the tablet disperse in the liquid. The tablet will not dissolve completely. Drink this mixture right away. To ensure 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.

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 Sprinkle 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.

Jadenu Sprinkle can harm your liver or kidneys. Call your doctor right away 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 Sprinkle may also cause stomach or intestinal bleeding. Call your doctor right away if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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.

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 Sprinkle 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 Sprinkle.

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

Jadenu Sprinkle may cause serious side effects. Stop using Jadenu Sprinkle and call your doctor right away 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, feeling tired, 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 side effects of Jadenu Sprinkle 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.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at the same 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 Sprinkle may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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

Many drugs can affect Jadenu Sprinkle. 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.