Deferasirox may rarely cause serious (even fatal) kidney disease, liver disease, and stomach/intestinal bleeding (see also Side Effects section). Kidney disease may be more likely to occur in people with kidney problems and in people with serious blood diseases. Liver disease may be more likely to occur in people with liver problems (such as cirrhosis) and in older adults. Stomach/intestinal bleeding may be more likely to occur in older adults with serious blood diseases (including blood cancers). Consult your doctor for more details.
Your doctor will monitor you closely while you are taking this medication. Keep all regular medical and laboratory appointments.
This medication is used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in patients with a certain blood disorder who do not require blood transfusions (non-transfusion dependent thalassemia). Deferasirox can be taken by mouth and belongs to a class of drugs known as iron chelating agents. It works by reacting with iron, allowing the body to pass extra iron out in the stool.
Frequent blood transfusions are often needed in certain types of blood diseases (e.g., sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. For patients who receive multiple blood transfusions and for patients who have non-transfusion dependent thalassemia but high iron levels, extra iron can build up in various organs and cause problems such as heart failure, liver disease and diabetes. Getting rid of extra iron can decrease the risk of these diseases.
Stir the tablet(s) into water, orange juice or apple juice until the tablets have completely broken apart and are well mixed into the liquid. If your dose is less than 1 gram, stir the tablets into about 1/2 cup (3.5 ounces) of liquid. If your dose is more than 1 gram, use about 1 cup (7 ounces) of liquid. Drink all of the mixture immediately, then add more liquid to the empty container and stir to get any drug that may remain. Drink all of this rinsing liquid immediately.
Take this medication on an empty stomach at least 30 minutes before food, usually once daily or as directed by your doctor. Do not chew the tablets or swallow them whole. Always mix this medication into liquid as directed.
Certain antacids that contain aluminum may decrease the amount of medication that your body can absorb. If you take an antacid, wait at least 2 hours after taking this medication.
Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day. Dosage is based on your medical condition, body size and response to therapy. Your dosage may need to be lowered or your treatment may need to be stopped if you get certain side effects. Follow your doctor's instructions carefully.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This drug may rarely cause serious (even fatal) liver disease. If you notice any of the following unlikely but serious side effects, tell your doctor immediately: persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing of eyes/skin.
This drug may rarely cause serious (even fatal) stomach/intestinal bleeding and ulcers. Tell your doctor immediately if you have any of the following rare but serious symptoms: severe stomach/abdominal pain, black/tarry/bloody stools, vomit that looks like coffee grounds.
This drug may rarely cause serious (even fatal) kidney or blood problems. Tell your doctor immediately if you notice any of the following symptoms: change in amount of urine, easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), unusual tiredness.
Deferasirox can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking deferasirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, low platelet counts, advanced cancer, certain bone marrow disorders involving damaged blood-forming cells (high-risk myelodysplastic syndromes).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
If you have diarrhea or vomiting, drink plenty of fluids to replace lost body water and minerals. Ask your doctor or pharmacist for more details.
Older adults may be more sensitive to the side effects of this drug, especially liver problems and stomach/intestinal bleeding and ulcers.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medication because very serious interactions may occur: other medications that remove iron from your body (e.g., deferoxamine).
If you are currently using the medication listed above, tell your doctor or pharmacist before starting deferasirox.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antacids, cholestyramine, repaglinide, any form of vitamin/mineral supplement.
Other medications can affect the removal of deferasirox from your body, which may affect how deferasirox works. Examples include rifamycins (such as rifabutin), drugs used to treat seizures (such as phenobarbital, phenytoin), among others.
Other medications may increase your risk for stomach/intestinal bleeding and ulcers when taken with deferasirox. Tell your doctor or pharmacist about all the medications you use, including: bisphosphonates taken by mouth (e.g., alendronate), "blood thinners" (e.g., anticoagulants such as heparin, warfarin), corticosteroids (e.g., prednisone).
Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, or naproxen) that may increase your risk of stomach/intestinal bleeding and ulcers if taken with deferasirox. Low-dose aspirin should be continued if prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day). Ask your doctor or pharmacist for more details.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Do not share this medication with others.
Laboratory and/or medical tests (e.g., serum ferritin, blood counts, liver and kidney function tests, vision and hearing tests, liver iron concentration) will be performed before starting and while you are receiving treatment with this medication to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.
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