June 24, 2010
FDA Video: Boxed Warning for Exjade
Novartis Oncology has alerted healthcare professionals about a new boxed warning and other safety changes in the labeling for Exjade (deferasirox). Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from multiple blood transfusions.
The boxed warning emphasizes that Exjade may cause renal or hepatic impairment, including kidney or liver failure. It also highlights the risk of gastrointestinal hemorrhage. These kidney, liver and GI reactions, which are sometimes fatal, have been seen more often in elderly patients and those with high-risk myelodysplastic syndromes, underlying renal or hepatic impairment, or low platelet counts.
Patients on Exjade must be closely monitored for kidney and liver function before starting and during therapy.