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Reference ID: 3366104 - ZEVALIN

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HIGHLIGHTS OF PRESCRIBING INFORMATION ---------------------DOSAGE FORMS AND STRENGTHS---------------------- These highlights do not include all the information needed to use mg per 2 mL in a single-use vial. (3). ZEVALIN safely and effectively. See full prescribing information for ZEVALIN . -------------------------------CONTRAIND ICATIONS------------------------------ None. ZEVALIN (ibritumomab tiuxetan). Injection for intravenous use -----------------------WARNINGS AND PRECAUTIONS------------------------ Initial Approval: 2002 Serious Infusion Reactions: Immediately discontinue rituximab and Y- 90 ZEVALIN . ( , ). WARNING: SERIOUS INFUSION REACTIONS, PROLONGED Prolonged and Severe Cytopenias: Do not administer ZEVALIN to patients AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND with 25% lymphoma marrow involvement or impaired bone marrow MUCOCUTANEOUS REACTIONS reserve.

2.1 Overview of Dosing Schedule 2.2 Zevalin Therapeutic Regimen Dosage and Administration Day 1: • Premedicate with acetaminophen 650 mg orally and diphenhydramine 50 mg orally prior to …

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