WARNINGS
Fatal Infusion Reactions: Deaths have occurred within 24 hours of Rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with an infusion reaction symptom complex that included hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Approximately 80% of fatal infusion reactions occurred in association with the first Rituximab infusion (See WARNINGS and ADVERSE REACTIONS). Patients who develop severe infusion reactions should have Rituximab, In-111 ZEVALIN, and Y-90 ZEVALIN infusions discontinued and receive medical treatment.
Prolonged and Severe Cytopenias: Y-90 ZEVALIN administration results in severe and prolonged cytopenias in most patients. The ZEVALIN therapeutic regimen should not be administered to patients with >/= 25% lymphoma marrow involvement and/or impaired bone marrow reserve (See WARNINGS and ADVERSE REACTIONS).
Dosing
- The prescribed, measured, and administered dose of Y-90 ZEVALIN should not exceed the absolute maximum allowable dose of 32.0 mCi (1184 MBq).
- Y-90 ZEVALIN should not be administered to patients with altered biodistribution as determined by imaging with In-111 ZEVALIN.
In-111 ZEVALIN and Y-90 ZEVALIN are radiopharmaceuticals and should be used only by physicians and other professionals qualified by training and experienced in the safe use and handling of radionuclides.
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