More Information on Exjade Label Update

June 12, 2009 – In response to patient requests, CAF asked CAF Medical Advisory Board Chair Ellis Neufeld to offer clarification regarding the recent label changes to Exjade.

Below is Dr. Neufeld’s response:

1. Deferasirox affects the liver to an important degree in a small fraction of patients who take it for iron overload. When liver disease does occur, particularly in ill, elderly patients (who probably don’t have thalassemia), severe or even lethal consequences have been reported. Fortunately this problem is rare, but because it has been observed, and can apparently be avoided by stopping the drug if the liver is abnormal, ongoing monitoring of liver tests is now suggested.

2. Members of the CAF medical advisory board have observed occasional significant liver problems on deferasirox in thalassemia patients. The new recommendations seem reasonably prudent.

3. For the majority of patients, they will notice nothing and there is NOT extra risk if their liver tests remain normal.

The dosing story is that some people don’t respond well enough to the prior FDA approved maximum of 30 mg/kg per day, and now a higher dose is allowed by the label. Patients should talk to their hematologist about whether higher doses are needed for them, and if they can tolerate these doses.


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