Warnings over deferasirox

Thursday 24th May 2007

Healthcare professionals have been notified of changes to US product labelling for Exjade™ (deferasirox), after additional safety concerns arose following postmarketing experience.

Exjade is used to treat transfusional haemosiderosis (chronic iron overload due to blood transfusions). Manufacturer Novartis and the FDA say the warning relates to associated acute renal failure and cytopenias.

Case reports of acute renal failure (sometimes fatal) followed postmarketing use of Exjade.

Most fatalities occurred in patients with multiple comorbidities and who were in advanced stages of their haematological disorders.

The US labelling recommends that serum creatinine should be assessed prior to initiation of Exjade to establish a baseline level, then monthly thereafter. Patients who are at increased risk of complications, have pre-existing renal conditions, are elderly, have comorbid conditions, or are receiving medicinal products that depress renal function should be monitored weekly during the first month after initiation or modification of therapy, and monthly thereafter.

There have also been postmarketing reports of cytopenias (including agranulocytosis, neutropenia and thrombocytopenia) in patients treated with Exjade, which have in some cases been fatal. Most of these patients had pre-existing haematological disorders, and the relationship of these episodes to treatment with Exjade is uncertain.

Cases of leukocytoclastic vasculitis, urticaria and hypersensitivity reactions (including anaphylaxis and angioedema) were also reported.

The US labelling recommends that blood counts be monitored regularly, and treatment interruption considered in patients who develop unexplained cytopenia. Reintroduction of therapy with Exjade may be considered once the cause of cytopenia has been elucidated.

National Electronic Library for Medicines 23/5/2007