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ZEVALIN
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

ZEVALIN Rx

Generic Name and Formulations:
Ibritumomab tiuxetan 3.2mg/2mL; soln for IV inj; contains albumin; preservative-free.

Company:
Spectrum Pharmaceuticals, Inc.

Therapeutic Use:

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.

Adult:

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.

Children:

Not established.

Boxed Warning:

Serious infusion reactions. Prolonged and severe cytopenias. Severe cutaneous and mucocutaneous reactions. Dosing.

Warnings/Precautions:

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.

Pharmacological Class:

Radionuclide (B-lymphocyte-restricted differentiation antigen [CD20] inhibitor).

Interactions:

Caution with anticoagulants, platelet aggregation inhibitors, or live viral vaccines. Separate growth factor treatment by 2 weeks before and after Zevalin therapy.

Adverse Reactions:

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.

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

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