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Published on 24 May 2007

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Warnings over deferasirox

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Healthcare professionals have been notified of changes to US productlabelling for Exjade™ (deferasirox), after additional safety concernsarose following postmarketing experience.

Exjade is usedto treat transfusional haemosiderosis (chronic iron overload due toblood transfusions). Manufacturer Novartis and the FDA say the warningrelates to associated acute renal failure and cytopenias.

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

Mostfatalities occurred in patients with multiple comorbidities and whowere in advanced stages of their haematological disorders.

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

Therehave also been postmarketing reports of cytopenias (includingagranulocytosis, neutropenia and thrombocytopenia) in patients treatedwith Exjade, which have in some cases been fatal. Most of thesepatients had pre-existing haematological disorders, and therelationship of these episodes to treatment with Exjade is uncertain.

Casesof leukocytoclastic vasculitis, urticaria and hypersensitivityreactions (including anaphylaxis and angioedema) were also reported.

TheUS labelling recommends that blood counts be monitored regularly, andtreatment interruption considered in patients who develop unexplainedcytopenia. Reintroduction of therapy with Exjade may be considered oncethe cause of cytopenia has been elucidated.

National Electronic Library for Medicines 23/5/2007



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