Leukemias, lymphomas, and other hematologic cancers:

Indications for ZEVALIN:

Relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL). Previously untreated follicular NHL in patients who achieve a partial or complete response to first-line chemotherapy.

Adult:

See full labeling. Prepare 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. Premedicate with oral acetaminophen and oral diphenhydramine prior to rituximab infusion. Day 1: single infusion of rituximab. Day 7, 8, or 9: second rituximab infusion; within 4hrs after, follow with 0.4mCi/kg of Y-90 Zevalin IV infusion over 10mins; if platelet count 100,000–149,000cells/mm3, give 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.

Warnings/Precautions:

Risk of serious infusion reactions; slow or interrupt infusions for less severe reactions; discontinue immediately if severe. Do not initiate if ≥25% lymphoma marrow involvement and/or impaired bone marrow reserve. Monitor for cytopenias and complications (eg, febrile neutropenia, hemorrhage) for up to 3 months after treatment. Obtain CBCs, platelets weekly until levels recover or clinically indicated. Discontinue if severe cutaneous and mucocutaneous reactions occur. Use only if trained in radionuclide therapy. Have available access to resuscitative measures. Monitor for hematologic toxicity (including MDS, AML). Avoid extravasation. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for ≥12mos after the last dose. Pregnancy; exclude status prior to initiation. Nursing mothers: not recommended (during and for 6mos after the last dose).

Pharmacologic Class:

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

Interactions:

Concomitant live vaccines: not recommended. Avoid concomitant drugs that interfere with platelet function or coagulation; if needed, monitor frequently for thrombocytopenia.

Adverse Reactions:

Cytopenias (may be severe), fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, pyrexia; secondary malignancies.

Note:

Yttrium-90 chloride sterile solution will be shipped directly upon placement of order for Y-90 Zevalin kit.

How Supplied:

Y-90 Zevalin kit (ibritumomab tiuxetan 3.2mg/2mL vial + sodium acetate vial + formulation buffer vial + empty reaction vial)—1