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ZEVALIN® (ibritumomab tiuxetan) Reimbursement / Coverage
ZEVALIN® (ibritumomab tiuxetan)
Kit for the preparation of 90Y-ibritumomab tiuxetan
Therapeutic radiopharmaceutical
The ZEVALIN® Insurance Reference Number is 00076192
Health Canada does not issue DIN numbers for radiopharmaceuticals such as ZEVALIN®. An Insurance Reference Number has been assigned to Zevalin to assist insurance companies in processing claims.
ZEVALIN® may be an eligible benefit through some private insurance plans, and also through some provincial and federal drug programs. The sidebar menu allows you to access specific information on coverage of ZEVALIN® by private insurance plans, the individual provincial drug benefit/ provincial cancer agency programs and through the federal drug plans. Information includes coverage/ reimbursement criteria and guidelines, special authorization forms, instructions and other resources. Click on the plan or program name to access.
Indication
ZEVALIN® (ibritumomab tiuxetan), as part of the ZEVALIN® therapeutic regimen, is indicated for the treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma, including patients with rituximab-refractory follicular non- Hodgkin’s lymphoma.
Contraindication
ZEVALIN® is contraindicated in patients with known type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of the ZEVALIN® therapeutic regimen, including yttrium chloride and rituximab.
Serious Warnings and Precautions
90Y-ZEVALIN® (ibritumomab tiuxetan) is a radiopharmaceutical and should be used only by physicians and other professionals qualified by training and experienced in the safe use and handling of radionuclides.
Fatal infusion reactions with rituximab:
- Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. Approximately 80% of fatal infusion reactions occurred in association with the first rituximab infusion. 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. Patients who develop severe infusion reactions should have rituximab and 90Y-ZEVALIN® infusions discontinued and receive medical treatment (see WARNINGS AND PRECAUTIONS – Sensitivity/Resistance and ADVERSE REACTIONS).
Prolonged and severe cytopenias:
- 90Y-ZEVALIN® administration can result in severe and prolonged cytopenias, especially when administered after prior radiation or multiple chemotherapies. The risk of hematological toxicity may be increased when ZEVALIN is administered shortly (< 4 months) after fludarabine-containing regimens. The ZEVALIN therapeutic regimen should not be administered to patients with > 25% lymphoma marrow involvement and/or impaired bone marrow reserve (see WARNINGS AND PRECAUTIONS – Hematologic and ADVERSE REACTIONS).
Severe mucocutaneous reactions:
- Severe mucocutaneous reactions, some with fatal outcome, have been reported in association with the ZEVALIN therapeutic regimen, which includes rituximab and 90Y-ZEVALIN. Patients who develop a severe mucocutaneous reaction should have rituximab and 90Y-ZEVALIN infusions discontinued and receive medical treatment (see WARNINGS AND PRECAUTIONS – Skin and ADVERSE REACTIONS).
Dosing:
- The prescribed, measured and administered dose of 90Y-ZEVALIN® should not exceed the absolute maximum allowable dose of 32.0 mCi (1184 MBq) (see DOSAGE AND ADMINISTRATION).
Resources for Healthcare Professionals and PatientsThe following websites are external links. DrugCoverage assumes no responsibility for the content of these sites. Product Monograph Patient InformationLYRITZ: BCCA Protocol Summary for Palliative Therapy For Lymphoma Using Radioimmunotherapy: Rituximab-Priming for Ibritumomab 90Y (ZEVALIN®). Protocol (BCCA Web Site)Cancer Care Ontario, Program in Evidence-Based Care
Ibritumomab Tiuxetan in Lymphoma: A Clinical Practice Guideline.This link will take you to the document on the Cancer Care Ontario web site. Click hereNational Comprehensive Cancer Network (NCCN)
Clinical Practice Guidelines - Non-Hodgkin's Lymphomas V.3.2007This link will take you to the document on the NCCN web site. See page 73 for Follicular Lymphoma. Click hereLymphoma Foundation Canada
Bayer and Bayer Cross are registered trademarks of Bayer AG, Zevalin® is a registered trademark of Idec Pharmaceuticals Corporation, used under license by Bayer Inc.
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