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U.S. Department of Health and Human Services

Safety

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Zevalin (Ibritumomab Tiuxetan) Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

  • Serious Infusion Reactions - Rituximab, alone or as a component of the Zevalin therapeutic regimen, can cause severe, including fatal, infusion reactions…
  • Prolonged and Severe Cytopenias - Cytopenias with delayed onset and prolonged duration, some complicated by hemorrhage and severe infection, are the most common severe adverse reactions of the Zevalin therapeutic regimen…
  • Risk of Developing Myelodysplastic Syndrome, Leukemia, and Other Malignancies - The radiation dose resulting from therapeutic exposure to Y-90 radiolabeled Zevalin may result in secondary malignancies…