Generic Name and Formulations:
Ibritumomab tiuxetan 3.2mg/2mL; soln for IV inj; contains albumin; preservative-free.
Spectrum Pharmaceuticals, Inc.
Indications for ZEVALIN:
B-cell non-Hodgkin's lymphoma (relapsed or refractory, low grade or follicular). Previously untreated follicular non-Hodgkin's lymphoma in patients who achieve a partial or complete response to first-line chemotherapy.
See full labeling. Prepare In-111 Zevalin and Y-90 Zevalin as directed. Initiate Zevalin therapy after recovery of platelets to ≥150,000/mm3 at least 6 weeks, but no more than 12 weeks, after the last dose of first-line chemotherapy. 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 100,000–149,000cells/mm3, reduce dose to 0.3 mCi/kg. Do not treat if platelets <100,000cells/mm3. Max Y-90 Zevalin dose: 32mCi.
Serious infusion reactions. Prolonged and severe cytopenias. Severe cutaneous and mucocutaneous reactions. Dosing.
Use only if trained in radionuclide therapy. Do not treat patients with altered biodistribution. Risk of serious infusion reactions; discontinue immediately if occurs. Have available access to resuscitative measures. ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve (eg, prior myeloablative therapies, platelet count <100,000cells/mm3, neutrophil count <1,500cells/mm3): 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. Embryo-fetal toxicity. Women of childbearing potential should use adequate contraception for at least 12 months. Pregnancy (Cat.D). Nursing mothers: not recommended.
Radionuclide (B-lymphocyte-restricted differentiation antigen [CD20] inhibitor).
Caution with anticoagulants, platelet aggregation inhibitors, or live viral vaccines. Separate growth factor treatment by 2 weeks before and after Zevalin therapy.
Neutropenia, leukopenia, thrombocytopenia, anemia, infections, asthenia, musculoskeletal symptoms, nausea, diarrhea, abdominal pain, pyrexia, fatigue, nasopharyngitis, cough, dizziness, hemorrhage; altered biodistribution, infusion reactions, severe cutaneous/mucocutaneous reactions (both may be fatal, discontinue if occurs); leukemia and myelodysplastic syndrome.
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.
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