EXJADE- deferasirox tablet, for suspension
Novartis Pharmaceuticals Corporation
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This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: July 2020 |
MEDICATION GUIDE
EXJADE® (ex jayde) (deferasirox) tablets for oral suspension |
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What is the most important information I should know about Exjade? Exjade can cause serious side effects, including: Kidney problems. Exjade can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have happened mostly in people who also have other health problems and had a blood disorder that was in an advanced stage. Adults and children who already have kidney problems and are taking certain medicines with Exjade may also have an increased risk of sudden kidney problems. Be sure to tell your healthcare provider about all the medicines you take during treatment with Exjade. Your healthcare provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with Exjade. Call your or your child’s healthcare provider right away if:
Liver problems. Exjade can cause liver problems, including liver failure that can sometimes cause death. Liver problems with Exjade may be more common in people who are over 55 years of age but can also happen in children. Liver failure has happened more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also happened along with kidney problems in certain children who become dehydrated. See “Kidney problems” above. Your healthcare provider should do blood tests to check your liver function before you start and regularly during treatment with Exjade. Call your healthcare provider right away, if you develop any of the following signs and symptoms: |
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Bleeding, ulcers, and tears of the stomach or intestine. Severe stomach and intestine bleeding (hemorrhage) that have caused death have happened in some people treated with Exjade, especially in elderly people who have advanced blood cancers or low platelet counts. Some people have also had ulcers of the stomach or intestine, sometimes with tears (perforation) that have caused death. In some people who have taken Exjade, including children and adolescents, irritation of the upper gastrointestinal tract, ulcers, and bleeding have happened, but did not cause death. Your risk of severe bleeding (hemorrhage) may be increased if you take Exjade along with other medicines that can cause ulcers or bleeding, such as: |
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Before you start taking Exjade, tell your healthcare provider if you are taking one of these medicines. Ask your healthcare provider if you are not sure. If you develop an ulcer of the stomach or intestine, or severe bleeding, your healthcare provider may stop Exjade.
Elderly people may be at a higher risk of developing serious side effects and death due to serious side effects with Exjade. Your healthcare provider may need to monitor you more closely during treatment with Exjade.
See "What are the possible side effects of Exjade?" for more information about side effects. |
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What is Exjade?
Exjade is a prescription medicine that is used to treat:
It is not known if Exjade is safe and effective when used with other medicines to treat an increased amount of iron in the blood. It is not known if Exjade is safe and effective for treating children under 2 years of age who have an increased amount of iron in their blood for a long period of time (chronic) caused by repeated blood transfusions. It is not known if Exjade is safe and effective for treating children under 10 years of age with thalassemia who have an increased amount of iron in their blood, but who are not receiving regular blood transfusions. |
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Do not take Exjade if you:
Ask your healthcare provider if you are not sure if you have any of the medical conditions listed above. |
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Before taking Exjade, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how Exjade works, and Exjade may affect how other medicines work. Also, your risk of sudden kidney problems or severe bleeding may be increased if you take Exjade with certain medicines. See “What is the most important information I should know about Exjade?”
Ask your healthcare provider if you are not sure if you take one of these medicines. Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine. |
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How should I take Exjade?
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What should I avoid while taking Exjade?
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What are the possible side effects of Exjade? Exjade can cause serious side effects, including:
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Severe skin reactions can also happen with Exjade and can be life-threatening or lead to death. Get medical help right away if you develop any one or more of the following signs and symptoms of a severe skin reaction, including: |
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Tell your healthcare provider if you develop any changes in your vision or hearing during treatment with Exjade. The most common side effects in anyone who takes Exjade include: diarrhea and nausea. Other common side effects in people with too much iron in their blood due to repeated blood transfusions include: vomiting, stomach-area (abdomen) pain, and an abnormal kidney function blood test. These are not all the possible side effects of Exjade. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store Exjade?
Keep Exjade and all medicines out of the reach of children. |
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General information about the safe and effective use of Exjade.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Exjade for a condition for which it was not prescribed. Do not give Exjade to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Exjade that is written for health professionals. |
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What are the ingredients in Exjade?
Active ingredient: deferasirox Inactive ingredients: Crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone (K30), silicone dioxide, and sodium lauryl sulphate. Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936 For more information, go to www.EXJADE.com or call 1-888-669-6682 © Novartis |
T2020-106