renal failure, cytopenia reported with deferasirox

Reactions 1144 - 24 Mar 2007 Renal failure, cytopenia reported with deferasirox Novartis has issued a ‘Dear Health Care Professional’ 1 letter and a public communication, 2 both endorsed by Health Canada, advising of a possible association between the use of Exjade [deferasirox] and renal failure and cytopenia. According to Novartis, reports of renal failure have been received following the postmarketing use of Exjade; 1,2 some of these reports had a fatal outcome. The fatalities could have been because of the underlying diseases; however, the company says that it is impossible to rule out a contributory role of Exjade. Discontinuation of Exjade in most of the nonfatal cases was associated with improvement in patients’ condition, which is suggestive of a contributory role of Exjade. The company says that serum creatinine levels should be monitored twice before initiating Exjade, followed by weekly monitoring in the first month of treatment, and monthly thereafter; proteinuria should be monitored every month and patients should be adequately hydrated. Also, Novartis has received reports of cytopenia in patients receiving Exjade, most of whom had pre-existing haematological disorders. Clinical trials have revealed dose-dependent increases in serum creatinine levels in patients receiving Exjade. 1 Increases in creatinine levels occurred at a greater frequency in Exjade recipients, compared with deferoxamine recipients. 1. Health Canada. Health Canada endorsed important safety information on Exjade (deferasirox). Internet Document : [3 pages], 9 Mar 2007. Available from: URL: http://www.hc-sc.gc.ca. 2. Health Canada. PUBLIC COMMUNICATION Health Canada Endorsed Important Safety Information on PrExjade* (deferasirox). Media Release : 9 Mar 2007. Available from: URL: http://www.hc-sc.gc.ca. 801013938 1 Reactions 24 Mar 2007 No. 1144 0114-9954/10/1144-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Reactions 1144 - 24 Mar 2007

Renal failure, cytopenia reportedwith deferasirox

Novartis has issued a ‘Dear Health Care Professional’1

letter and a public communication,2 both endorsed byHealth Canada, advising of a possible associationbetween the use of Exjade [deferasirox] and renal failureand cytopenia.

According to Novartis, reports of renal failure havebeen received following the postmarketing use ofExjade;1,2 some of these reports had a fatal outcome. Thefatalities could have been because of the underlyingdiseases; however, the company says that it isimpossible to rule out a contributory role of Exjade.Discontinuation of Exjade in most of the nonfatal caseswas associated with improvement in patients’ condition,which is suggestive of a contributory role of Exjade. Thecompany says that serum creatinine levels should bemonitored twice before initiating Exjade, followed byweekly monitoring in the first month of treatment, andmonthly thereafter; proteinuria should be monitoredevery month and patients should be adequatelyhydrated. Also, Novartis has received reports ofcytopenia in patients receiving Exjade, most of whomhad pre-existing haematological disorders. Clinical trialshave revealed dose-dependent increases in serumcreatinine levels in patients receiving Exjade.1 Increasesin creatinine levels occurred at a greater frequency inExjade recipients, compared with deferoxaminerecipients.1. Health Canada. Health Canada endorsed important safety information on Exjade

(deferasirox). Internet Document : [3 pages], 9 Mar 2007. Available from: URL:http://www.hc-sc.gc.ca.

2. Health Canada. PUBLIC COMMUNICATION Health Canada EndorsedImportant Safety Information on PrExjade* (deferasirox). Media Release : 9 Mar2007. Available from: URL: http://www.hc-sc.gc.ca.

801013938

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