Deferasirox tablets for oral suspension

What is this medication?

DEFERASIROX (de FER a sir ox) binds to iron in the blood. It helps to treat too much iron in the blood.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Exjade

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• cancer
• eye disease, vision problems
• hearing problems
• history of blood diseases
• kidney disease
• liver disease
• low blood counts, like low white cell, platelet, or red cell counts
• an unusual or allergic reaction to deferasirox, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 30 minutes before or 2 hours after food. Do not take with food. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• dasabuvir; ombitasvir, paritaprevir; ritonavir
• iron supplements
• ombitasvir; paritaprevir; ritonavir

This medicine may also interact with the following medications:

• antacids
• birth control pills
• certain medicines for cholesterol like cholestyramine, colesevelam, colestipol, simvastatin
• certain medicines for osteoporosis like alendronate, risedronate
• certain medicines for seizures like phenobarbital, phenytoin
• certain medicines that treat or prevent blood clots like warfarin
• conivaptan
• cyclosporine
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• paclitaxel
• repaglinide
• rifampin
• ritonavir
• steroid medicines like prednisone or cortisone
• theophylline

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your doctor or health care provider if your symptoms do not start to get better or if they get worse.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Your vision, hearing, and blood may be tested before and during use of this medicine.

If you get black, tarry stools or vomit up what looks like coffee grounds, call your doctor or health care provider right away. You may have a bleeding ulcer.

You may get dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

Check with your doctor or health care provider if your child gets an attack of severe diarrhea, nausea and vomiting, or if they sweat a lot. The loss of too much body fluid can make it dangerous for them to take this medicine.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• decreased hearing
• fever or chills, sore throat
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling or loosening of skin, including inside the mouth
• signs and symptoms of bleeding such as bloody or black, tarry stools; spitting up blood or brown material that looks like coffee grounds
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• trouble passing urine or change in the amount of urine
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• diarrhea
• nausea, vomiting
• stomach pain
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.