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U.S. Department of Health and Human Services


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Zenapax (daclizumab)

Audience: Transplantation healthcare professionals

FDA and Roche revised the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and CLINICAL STUDIES sections of the prescribing information to include important new safety information describing the increased mortality seen in a cardiac transplant study and other updated information regarding hypersensitivity reactions. Other sections of the ZENAPAX labeling impacted by the addition of the information from the cardiac transplant study have also been revised.

[August 2003 - Letter - Roche]