Monitor patients receiving medications that interfere with platelet function or coagulation more frequently for thrombocytopenia and bleeding. (7)
USE IN SPECIFIC POPULATIONS
Nursing Mother: Discontinue nursing. (8.3)
See 17 for PATIENT COUNSELING INFORMATION
Revised: 09/2009
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS
1 INDICATIONS AND USAGE
1.1 Relapsed or Refractory, Low-grade or Follicular NHL
1.2 Previously Untreated Follicular NHL
2 DOSAGE AND ADMINISTRATION
2.1 Overview of Dosing Schedule
2.2 Zeva lin Therapeutic Regimen Dosage and Administration
2.3 Directions for Preparation of Radiolabeled In-111 and Y-90 Zeva lin Doses
2.4 Procedure for Determining Radiochemical Purity
2.5 Image Acquisition and Interpretation of Biodistribution
2.6 Radiation Dosimetry
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infusion Reactions
5.2 Prolonged and Severe Cytopenias
5.3 Severe Cutaneous and Mucocutaneous Reactions
5.4 Altered Biodistribution
5.5 Leukemia and Myelodysplastic Syndrome
5.6 Embryo-Fetal Toxicity
5.7 Extravasation
5.8 Immunization
5.9 Laboratory Monitoring
5.10 Radionuclide Precautions
5.11 Creutzfeldt-Jakob Disease (CJD)
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Immunogenicity
6.3 Post-Marketing Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Relapsed or Refractory, Low-grade or Follicular Lymphoma
14.2 Follicular, B-Cell NHL Upon Completion of First-Line Chemotherapy
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
18. Principal Display Panel
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FULL PRESCRIBING INFORMATION
WARNING: SERIOUS INFUSION REACTIONS, PROLONGED AND SEVERE CYTOPENIAS, and SEVERE CUTANEOUS AND MUCOCUTANEOUS REACTIONS
Serious Infusion Reactions: Deaths have occurred within 24 hours of rituximab infusion, an essential component of the Zeva lin therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]. Discontinue rituximab, In-111 Zeva lin, and Y-90 Zeva lin infusions in patients who develop severe infusion reactions.
Prolonged and Severe Cytopenias: Y-90 Zeva lin administration results in severe and prolonged cytopenias in most patients. Do not administer the Zeva lin therapeutic regimen to pat |
