3.2 mg ibritumomab tiuxetan per 2 mL, single-use vial.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infusion Reactions
See also prescribing information for rituximab.
Rituximab, alone or as a component of the Zeva lin therapeutic regimen, can cause severe, including fatal, infusion reactions. These reactions typically occur during the first rituximab infusion with time to onset of 30 to 120 minutes. Signs and symptoms of severe infusion reactions may include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, and cardiogenic shock. Temporarily slow or interrupt the rituximab infusion for less severe infusion reactions. Immediately stop rituximab, In-111 Zeva lin, or Y-90 Zeva lin administration for severe infusion reactions [see Boxed Warning and Dosage and Administration (2.2)].
5.2 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 Zeva lin therapeutic regimen. When used according to recommended doses, the incidences of severe thrombocytopenia and neutropenia are greater in patients with mild baseline thrombocytopenia (100,000 to 149,000 /mm3) compared to those with normal pretreatment platelet counts. Severe cytopenias persisting more than 12 weeks following administration can occur [see Boxed Warning and Adverse Reactions (6.1)].
Do not administer the Zeva lin therapeutic regimen to patients with ≥ 25% lymphoma marrow involvement and/or impaired bone marrow reserve. Monitor patients for cytopenias and their complications (e.g., febrile neutropenia, hemorrhage) for up to 3 months after use of the Zeva lin therapeutic regimen. Avoid using drugs which interfere with platelet function or coagulation following the Zeva lin therapeutic regimen.
5.3 Severe Cutaneous and Mucocutaneous Reactions
Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis, and exfoliative dermatitis, some fatal, were reported in post-marketing experience. The time to onset of these reactions was variable, ranging from a few days to 4 months after administration of the Zeva lin therapeutic regimen. Discontinue the Zeva lin therapeutic regimen in patients experiencing a severe cutaneous or mucocutaneous reaction [see Boxed Warning and Adverse Reactions (6.3)].
5.4 Altered Biodistribution
Do not administer Y-90 Zeva lin to patients with altered biodistribution of In-111 Zeva lin. In a post-marketing registry designed to collect biodistribution images and other information in reported cases of altered biodistribution, there were 12 (1.3%) patients reported to have altered biodistribution among 953 patients registered. For descriptions of expected and altered biodistribution image characteristics [see Dosage and Administration (2.5)].
5.5 Leukemia and Myelodysplastic Syndrome
Myelodysplastic syndrome (MDS) and/or acute myelogenous leukemia (AML) were reported in 5.2% (11/211) of patients with relapsed or refractory NHL enrolled in clinical studies and 1.5% (8/535) of patients included in the expanded-access trial, with median follow-up of 6.5 and 4.4 years, respectively. Among the 19 reported cases, the median time to the diagnosis of MDS or AML was 1.9 years following tr |
