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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[Posted 09/25/2009] FDA notified healthcare professionals of an Early Communication regarding an ongoing review of safety issues with deferasirox (Exjade). New safety data suggests there may be a greater number of adverse events and deaths in patients using deferasirox who are over sixty years old who have myelodysplastic syndrome (MDS). Deferasirox, an iron chelator, is an oral medication approved in 2005 for patients aged two and older with chronic anemia (low red blood cell counts) and iron overload as a result of receiving blood transfusions. FDA is working with Novartis to add new information in the Contraindications, Warnings, and Precautions sections of the prescribing information, to alert healthcare professionals of the risks and adverse events, including acute renal failure and gastrointestinal hemorrhages that in rare cases, especially in older patients with blood-related malignancies and/or low platelet counts, have been fatal. Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online at: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178]. Considerations for healthcare professionals, information for patients, and a Data Summary are provided. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety. |
Deferasirox is used to remove excess iron that is in the body because of blood transfusions. Deferasirox is in a class of medications called iron chelators. It works by attaching to iron molecules in the body so they can be excreted (removed from the body) in feces.
Deferasirox comes as a tablet for suspension (a tablet to dissolve in liquid) to take by mouth. It should be taken on an empty stomach once a day, at least 30 minutes before food. Take deferasirox at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take deferasirox exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Do not chew or swallow the tablets whole.
To take the tablets for suspension, follow these steps:
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Before taking deferasirox,
Unless your doctor tells you otherwise, continue your normal diet.
Take the missed dose later in the day, at least 2 hours after your last meal and 30 minutes before food. However, if it is almost time for the next dose or if you will not be able to take deferasirox on an empty stomach, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Deferasirox may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
Deferasirox may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to deferasirox. Your doctor may adjust your dose of deferasirox every 3 to 6 months.You will need to have hearing and eye exams before starting deferasirox and once a year while taking this medication.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Reviewed - 09/01/2008
AHFS® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
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Page last updated: 18 November 2009 |