eatment with the Zeva lin therapeutic regimen; however, the cumulative incidence continues to increase [see Adverse Reactions (6.1)].
Among 204 patients receiving Y-90 Zeva lin following first-line chemotherapy, two patients (1%) were diagnosed with AML within 3 years of receiving Zeva lin.
5.6 Embryo-Fetal Toxicity
Based on its radioactivity, Y-90 Zeva lin may cause fetal harm when administered to a pregnant woman. If the Zeva lin therapeutic regimen is administered during pregnancy, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].
5.7 Extravasation
Monitor patents closely for evidence of extravasation during Zeva lin infusion. Immediately terminate the infusion if signs or symptoms of extravasation occur and restart in another limb [see Dosage and Administration (2.2)].
5.8 Immunization
The safety of immunization with live viral vaccines following the Zeva lin therapeutic regimen has not been studied. Do not administer live viral vaccines to patients who have recently received Zeva lin. The ability to generate an immune response to any vaccine following the Zeva lin therapeutic regimen has not been studied.
5.9 Laboratory Monitoring
Monitor complete blood counts (CBC) and platelet counts following the Zeva lin therapeutic regimen weekly until levels recover or as clinically indicated.
5.10 Radionuclide Precautions
During and after radiolabeling Zeva lin with In-111 or Y-90, minimize radiation exposure to patients and to medical personnel, consistent with institutional good radiation safety practices and patient management procedures.
5.11 Creutzfeldt-Jakob Disease (CJD)
The Zeva lin therapeutic regimen contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, Zeva lin carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
Serious Infusion Reactions [see Boxed Warning and Warnings and Precautions (5.1)].
Prolonged and Severe Cytopenias [see Boxed Warning and Warnings and Precautions (5.2)].
Severe Cutaneous and Mucocutaneous Reactions [see Boxed Warning and Warnings and Precautions (5.3)].
Leukemia and Myelodysplastic Syndrome [see Warnings and Precautions (5.5)].
The most common adverse reactions of Zeva lin are cytopenias, fatigue, abdominal pain, nausea, nasopharyngitis, asthenia, diarrhea, cough and pyrexia.
The most serious adverse reactions of Zeva lin are prolonged and severe cytopenias (thrombocytopenia, anemia, lymphopenia, neutropenia) and secondary malignancies.
Because the Zeva lin therapeutic regimen includes the use of rituximab, see prescribing information for rituximab.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The reported safety data reflects exposure to Zeva lin in 349 patients with relapsed or ref |
