AR: Novartis Oncology has alerted healthcare professionals about a new boxed warning and other safety changes in the labeling for Exjade, or deferasirox. Exjade is used to treat transfusional hemosiderosis, the chronic iron overload that can result from multiple blood transfusions.
MB: 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 are sometimes fatal. They've been seen more often in elderly patients and those with high-risk myelodysplastic syndromes, underlying renal or hepatic impairment, or low platelet counts.
AR: Patients on Exjade must be closely monitored for kidney and liver function before starting and during therapy. You can find the specific monitoring schedules in the Exjade prescribing information, or by going to our website.

标题
Boxed Warning for Exjade (FDA)

视频介绍
FDA Patient Safety News - June, 2010 - Show #99
Novartis Oncology has alerted healthcare professionals about a new boxed warning and other safety changes in the labeling for Exjade, or deferasirox.

Speaker #1: Anita Rayner (AR), Associate Director, Policy & Communications, U.S. Food and Drug Administration

Speaker #2: Mark Barnett (MB), Assistant Director, Education & Communication, U.S. Food and Drug Administration