Deferasirox 500mg Tablets for Oral Suspension

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

DEFERASIROX TABLET - FOR ORAL SUSPENSION

(deaf-ur-ES-ur-ox)

COMMON BRAND NAME(S): Exjade

WARNING: 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.

USES: 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 people with a certain blood disorder who do not require blood transfusions (non-transfusion-dependent thalassemia). It works by binding to iron, allowing the body to pass extra iron out in the stool. Deferasirox belongs to a class of drugs known as iron-chelating agents. Frequent blood transfusions are often needed in certain types of blood diseases (such as sickle cell disease, anemia). Blood transfusions have very helpful benefits, but they can cause the body to hold on to too much iron. The extra iron can build up in the body and cause problems such as heart failure, liver disease, and diabetes. Getting rid of extra iron can decrease the risk of these diseases.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking deferasirox and each time you get a refill. If you have any questions, ask your doctor or pharmacist. 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/100 milliliters) of liquid. If your dose is more than 1 gram, use about 1 cup (7 ounces/200 milliliters) of liquid. Drink all of the mixture right away, then add more liquid to the empty container and stir to get any drug that may remain. Drink all of this rinsing liquid right away. Take this medication by mouth on an empty stomach at least 30 minutes before food as directed by your doctor, usually once daily. Do not chew the tablets or swallow them whole. Always mix this medication into liquid as directed. Antacids that contain aluminum can bind with deferasirox which may affect how deferasirox works. Avoid taking this medication with antacids that contain aluminum. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. The dosage is based on your medical condition, weight, laboratory tests, and response to treatment. 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.

SIDE EFFECTS: Nausea, vomiting, diarrhea, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. 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. Tell your doctor right away if you have any serious side effects, including: hearing loss, vision changes (such as blurred vision). This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can worsen anemia, decrease your body\'s ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding. This drug may rarely cause serious stomach/intestinal problems (such as stomach/intestinal bleeding and ulcers). If you notice any of the following unlikely but serious side effects, stop taking deferasirox and consult your doctor or pharmacist right away: black/bloody stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain. Deferasirox may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing of eyes/skin, dark urine. Deferasirox has rarely caused very serious (possibly fatal) kidney problems. Tell your doctor right away if you develop signs of kidney problems, such as: change in the amount of urine, frothy urine. 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 right away if you develop any rash. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 disease, liver disease, low platelet counts, advanced cancer, certain bone marrow disorders involving damaged blood-forming cells (high-risk myelodysplastic syndromes). This drug may make you dizzy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Tell the doctor right away if you develop any illness that may cause a serious loss of body water (including fever, diarrhea, or vomiting) or if you are unable to drink fluids. The doctor may need to stop or adjust deferasirox treatment, especially in children. Children may be more sensitive to the side effects of this drug, especially kidney problems and hearing loss. Older adults may be more sensitive to the side effects of this drug, especially liver problems, stomach/intestinal bleeding, and ulcers. This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. It is unknown if this medication 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.

DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: other drugs that can cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen/naproxen, \"blood thinners\" such as dabigatran/warfarin). Aspirin can increase the risk of bleeding when used with this medication. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use reliable backup birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory and/or medical tests (such as serum ferritin, blood counts, urine tests, liver and kidney function tests, vision and hearing tests, liver iron concentration) must be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

MISSED DOSE: 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. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications 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.

Information last revised August 2019. Copyright(c) 2019 First Databank, Inc.