Monograph Details
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Neoplasms
> Monoclonal antibodies
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ZEVALIN |
| Manufacturer |
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Cell Therapeutics, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Radionuclide (B-lymphocyte-restricted differentiation antigen [CD20] inhibitor) |
| Generic Name |
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Ibritumomab tiuxetan 3.2mg/2mL; soln for IV inj; contains albumin; preservative-free. |
| Indications |
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B-cell non-Hodgkin's lymphoma (relapsed or refractory, low grade, follicular, transformed, or rituximab-refractory). |
| Children |
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Not recommended. |
| Adults |
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See literature. Prepare In-111 Zevalin and Y-90 Zevalin as directed. Administered in two steps. Step 1: Single infusion of rituximab followed by a fixed dose of 5mCi (1.6mg total antibody dose) of In-111 Zevalin given as a 10-minute IV push. Step 2 (7–9 days after Step 1): Second rituximab infusion followed by 0.4mCi/kg of Y-90 Zevalin given as a 10-minute IV push; if platelet count 100000–149000cells/mm3, reduce dose to 0.3 mCi/kg. Do not treat if platelets <100000cells/mm3. Max Y-90 Zevalin dose: 32mCi. |
| Contraindications |
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Hypersensitivity to murine proteins. |
| Precautions |
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See literature. Use only if trained in radionuclide therapy. Do not treat patients with altered biodistribution. ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve (eg, prior myeloablative therapies, platelet count <100000cells/mm3, neutrophil count <1500cells/mm3), or history of failed stem cell collection: not recommended. Monitor for cytopenias and complications (eg, febrile neutropenia, hemorrhage) for up to 3 months after treatment. Obtain CBCs, platelets weekly until levels recover. Avoid extravasation. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended. |
| Interactions |
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Caution with anticoagulants, platelet aggregation inhibitors, or live viral vaccines. Separate growth factor treatment by 2 weeks before and after Zevalin therapy. |
| Adverse Reactions |
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Neutropenia, thrombocytopenia, anemia, GI upset, abdominal pain, cough, dyspnea, dizziness, arthralgia, anorexia, anxiety, ecchymosis, prolonged and severe cytopenias, infections, hemorrhage, altered biodistribution; infusion reactions, severe cutaneous/mucocutaneous reactions: both may be fatal, discontinue if occurs; myeloid malignancies, dysplasias. |
| Extra Text |
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Note: Indium-11 chloride sterile solution must be ordered separately at the time the In-11 Zevalin kit is ordered. Yttrium-90 chloride sterile solution will be shipped directly upon placement of order for Y-90 Zevalin kit. |
| How Supplied |
In-111 Zevalin kit (ibritumomab tiuxetan 3.2mg/2mL vial + sodium acetate vial + formulation buffer vial + empty reaction vial)—1
Y-90 Zevalin kit (ibritumomab tiuxetan 3.2mg/2mL vial + sodium acetate vial + formulation buffer vial + empty reaction vial)—1 |
| Additional Resources |
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• Related Prescribing Note |
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