Safety Alerts & Recalls

What does this mean?

EXJADE is used to treat the serious condition of chronic iron overload. For most patients, the use of EXJADE will continue to outweigh these concerns of reduced kidney and liver function and excessive bleeding in the stomach or intestines. That said, if you are currently taking EXJADE (or DEFERASIROX) be sure to keep your doctor's appointments so that your blood can be tested regularly and closely monitored for complications.

If you have any unexplained symptoms of nausea, vomiting, tiredness, lack of energy, loss of appetite, pain in the upper right part of the stomach, yellowing of the skin or eyes, flu-like symptoms, unusual bleeding or bruising, or abnormally dark or red colored bowel movements, please contact your doctor as soon as possible - these maybe early warning signs of serious side effects from EXJADE.

If you have any questions about this information, please follow-up directly with your health care professional.

Boxed Warning and Other Changes to the EXJADE Prescribing Information

Novartis Oncology and the FDA notified healthcare professionals about recent changes in the Prescribing Information (PI) for EXJADE. New information was added to the Contraindications; Warnings and Precautions; and Drug Interactions sections of the PI, including a Boxed Warning, that the product may cause: decreased kidney function, including failure; decreased liver function, including failure; and gastrointestinal hemorrhage (excessive bleeding in the stomach or intestines).

In some reported cases, these reactions were fatal. Reactions were more frequently seen in patients who are older, have leukemia, or have underlying kidney or liver impairment or low platelet counts. EXJADE therapy requires close patient monitoring, including blood tests to measure how well the kidney and liver are working.

EXJADE contains the active ingredient DESFERASIROX and is indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2010-02-18
Last Updated: 2010-02-20

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