New Warnings on Exjade

Posted on April 29, 2008

Novartis has notified healthcare professionals that new warnings have been added to the labeling for Exjade (defarasirox). Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from blood transfusions.

Cases of acute renal failure, some of them fatal, have been reported in patients taking this drug. Most occurred in patients with multiple co-morbidities who were in advanced stages of their hematological disorders.

Before beginning therapy with Exjade, all patients should have their serum creatinine assessed in duplicate to establish a baseline level, and then creatinine should be monitored monthly during treatment. Patients who may be at increased risk of complications should be monitored weekly during the first month of Exjade therapy or when the treatment is modified, and then monthly thereafter.
These high-risk patients include the elderly, people with pre-existing renal disease or other co-morbid conditions, and those receiving drugs that can depress renal function.

There have also been reports of cytopenias in patients on Exjade, some of them fatal. The relationship between the drug and these effects is uncertain, since most of the patients had pre-existing hematological disorders that themselves are associated with bone marrow failure. Blood counts should be monitored regularly and treatment interrupted in patients who develop unexplained cytopenia.

Additional Information:

FDA MedWatch Safety Alert. Exjade (deferasirox) Tablets For Oral Suspension. May 22, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Exjade