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U.S. Department of Health and Human Services

Safety

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Zevalin (ibritumomab tiuxetan)

Audience: Hemato-oncologists and other healthcare professionals

[Posted 10/28/2005] Biogen Idec and FDA notified healthcare professionals of revision to BOXED WARNINGS, WARNINGS, and ADVERSE REACTIONS sections of the Prescribing Information to describe severe cutaneous or mucocutaneous reactions, some with fatal outcome, that have been reported in association with the Zevalin therapeutic regimen in the post-marketing experience. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the Zevalin therapeutic regimen and should seek prompt medical evaluation.

[October 2005 - Letter - Biogen]
[September 2005 - Label - Biogen]