Deferasirox Oral suspension

What is this medicine?

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

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

What should I tell my health care provider before I take this medicine?

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

• a blood disorder

• cancer

• hearing problems

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• vision problems

• 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 medicine?

Take this medicine by mouth. Do not chew or take tablets whole. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 30 minutes before food. Do not take with food. Before taking, mix the dose in water, orange juice, or apple juice as directed. If your dose is less than 1 gram, use 3.5 ounces or about 1/2 glass of liquid. If your dose is 1 gram or more, use 7 ounces or about 1 full glass of liquid. Stir the medicine into the liquid until the tablets dissolve. Drink your dose right away after mixing. If there is any medicine left in the glass after you drink the mixture, add a little bit more liquid, swirl it around, and drink. Take your doses at regular intervals. Do not take your medicine more often than directed.

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 medicine?

• antacids that have aluminum

• cholestyramine

• iron supplements or vitamins that have iron

• other iron binders like deferoxamine

• phenobarbital

• phenytoin

• rifampin

• ritonavir

• vitamin C

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 medicine?

Visit your doctor for regular check ups. You will need important blood work, vision tests, and hearing tests done while you are taking this medicine.

You may get drowsy or 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.

Avoid taking antacids containing aluminum at the same time as this medicine.

What side effects may I notice from receiving this medicine?

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

• black or bloody stools or blood in vomit

• changes in hearing

• changes in vision

• dark urine

• fever or chills, sore throat

• general ill feeling or flu-like symptoms

• loss of appetite, nausea

• right upper belly pain

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

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

• cough

• diarrhea

• headache

• 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 medicine?

Keep out of the reach of children.

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

Deferasirox Oral tablet

What is this medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• a blood disorder

• cancer

• hearing problems

• kidney disease

• liver disease

• low blood counts, like low white cell, platelet, or red cell counts

• vision problems

• 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 medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach. Take this 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 medicine?

• alosetron

• antacids that have aluminum

• aprepitant; fosaprepitant

• birth control pills

• certain medicines for blood pressure, heart disease, irregular heart beat like conivaptan, dronedarone, eplerenone, felodipine, nisoldipine, quinidine, tolvaptan

• certain medicines for cholesterol like cholestyramine, colesevelam, colestipol, lovastatin, simvastatin

• certain medicines for depression, anxiety, or psychotic disturbances like buspirone, duloxetine, lurasidone, melatonin, midazolam, pimozide, quetiapine, ramelteon, tacrine, triazolam

• certain medicines for erectile dysfunction like sildenafil, vardenafil

• certain medicines for HIV like darunavir, indinavir, lopinavir; ritonavir, maraviroc, saquinavir, ritonavir, tipranavir

• certain medicines for migraine headaches like dihydroergotamine, eletriptan, ergotamine

• certain medicines for pain like alfentanil, fentanyl

• certain medicines for seizures like phenobarbital, phenytoin

• certain medicines that lower your chance of fighting infection like budesonide, cyclosporine, dasatinib, everolimus, fluticasone, paclitaxel, sirolimus, tacrolimus

• darifenacin

• iron supplements or vitamins that have iron

• other iron binders like deferoxamine

• repaglinide

• rifampin

• theophylline and caffeine

• ticagrelor

• tizanidine

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 medicine?

Visit your doctor for regular check ups. You will need important blood work, vision tests, and hearing tests done while you are taking this medicine.

You may get drowsy or 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.

Avoid taking antacids containing aluminum at the same time as this medicine.

What side effects may I notice from receiving this medicine?

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

• black or bloody stools or blood in vomit

• changes in hearing

• changes in vision

• dark urine

• fever or chills, sore throat

• general ill feeling or flu-like symptoms

• loss of appetite, nausea

• right upper belly pain

• trouble passing urine or change in the amount of urine

• unusual bleeding or bruising

• unusually weak or tired

• yellowing of the eyes or skin

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

• cough

• diarrhea

• headache

• 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 medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from moisture. 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.