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WARNING
SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS
Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zevalin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities
occurred with the first rituximab infusion [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Discontinue rituximab, In-111 Zevalin, and Y-90 Zevalin infusions in patients who develop severe infusion reactions.
Prolonged and Severe Cytopenias: Y-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Do not administer the Zevalin therapeutic regimen to patients with = 25% lymphoma marrow involvement and/or impaired bone marrow reserve [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Severe Cutaneous and Mucocutaneous Reactions: Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the Zevalin therapeutic regimen. Discontinue rituximab, In-111 Zevalin, and Y-90 Zevalin infusions in patients experiencing severe cutaneous or mucocutaneous reactions [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Dosing: The dose of Y-90 Zevalin should not exceed 32.0 mCi (1184 MBq). Do not administer Y-90 Zevalin to patients with altered biodistribution as determined by imaging with In-111 Zevalin [see DOSAGE AND ADMINISTRATION].
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