Zeva lIN - ibritumomab tiuxetan   
Spectrum Pharmaceuticals, Inc.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Zeva lin safely and effectively. See full prescribing information for Zeva lin.
Initial U.S. Approval: 2002
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS
See full prescribing information for complete boxed warning.
Serious Infusion Reactions, some fatal, may occur within 24 hours of rituximab infusion. (5.1)
Prolonged and Severe Cytopenias occur in most patients. (5.2)
Severe Cutaneous and Mucocutaneous Reactions, some fatal, reported with Zeva lin therapeutic regimen. (5.3, 6.3)
Do not administer Y-90 Zeva lin to patients with altered biodistribution. (5.4)
Do not exceed 32 mCi (1184 MBq) of Y-90 Zeva lin. (2.2)
RECENT MAJOR CHANGES
Indications and Usage (1) 9/2009
Dosage and Administration (2) 9/2009
Warnings and Precautions (5) 9/2009
INDICATIONS AND USAGE
Zeva lin is a CD20-directed radiotherapeutic antibody administered as part of the Zeva lin therapeutic regimen indicated for the treatment of patients with:
relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL) (1.1).
previously untreated follicular NHL who achieve a partial or complete response to first-line chemotherapy (1.2).
DOSAGE AND ADMINISTRATION
Day 1: Administer rituximab 250 mg/m2 IV. Within 4 hours after rituximab infusion, administer 5 mCi In-111 Zeva lin IV. (2.2)
Day 7, 8, or 9:
Administer rituximab 250 mg/m2 IV infusion. (2.2)
If platelets ≥ 150,000/mm3: Within 4 hours after rituximab infusion, administer 0.4 mCi/kg (14.8 MBq per kg) Y-90 Zeva lin IV.
If platelets ≥ 100,000 but ≤ 149,000/mm3 in relapsed or refractory patients: Within 4 hours after rituximab infusion, administer 0.3 mCi/kg (11.1 MBq per kg) Y-90 Zeva lin IV.
DOSAGE FORMS AND STRENGTHS
3.2 mg per 2 mL, single-use vial. (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
Serious Infusion Reactions: Immediately stop and permanently discontinue rituximab, In-111 Zeva lin, and Y-90 Zeva lin. (5.1, 6.1)
Prolonged and Severe Cytopenias: Do not administer Zeva lin to patients with ≥ 25% lymphoma marrow involvement or impaired bone marrow reserve. (5.2, 6.1)
Severe Cutaneous and Mucocutaneous Reactions: Discontinue rituximab, or Zeva lin infusions if patients develop severe cutaneous or mucocutaneous reactions. (5.3, 6.3)
Leukemia and Myelodysplastic Syndrome (5.5, 6.1)
Embryo-fetal Toxicity: May cause fetal harm if given during pregnancy. (5.6, 8.1)
Extravasation: Monitor for extravasation and terminate infusion if it occurs. Resume infusion in another limb. (5.7, 6.3)
Immunization: Do not administer live viral vaccines to patients who recently received Zeva lin. (5.8)
Laboratory Monitoring: Obtain complete blood counts (CBC) and platelet counts at least weekly. (5.9)
ADVERSE REACTIONS
Common adverse reactions (> 40%) in clinical trials were: neutropenia, leukopenia, thrombocytopenia, anemia, infection, asthenia, musculoskeletal symptoms and gastrointestinal symptoms. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-866-298-8433 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS