Rituximab 英文说明书.pdf

1 of 35 Final Labeling Text HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Rituxan safely and effectively. See full prescribing information for Rituxan. Rituxan (rituximab) Injection for Intravenous Use Initial U.S. Approval: 1997 WARNING: FATAL INFUSION REACTIONS, TUMOR LYSIS SYNDROME (TLS), SEVERE MUCOCUTANEOUS REACTIONS, and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) See full prescribing information for complete boxed warning. ? Fatal infusion reactions within 24 hours of Rituxan infusion occur; approximately 80% of fatal reactions occurred with first infusion. Monitor patients and discontinue Rituxan infusion for severe reactions (5.1). ? Tumor lysis syndrome (5.2). ? Severe mucocutaneous reactions, some with fatal outcomes (5.3). ? PML resulting in death (5.4). --------------------------RECENT MAJOR CHANGES------------------------ Indications and Usage, CLL (1.2) Indications and Usage, RA (1.3) Indications and Usage, Limitations of Use (1.4) Dosage and Administration, CLL (2.3) Dosage and Administration, RA (2.5) Dosage and Administration, Recommended Concomitant Medications (2.6) Warnings and Precautions, Infusion Reactions (5.1) Warnings and Precautions, Infections (5.6) Warnings and Precautions, Renal (5.8) Warnings and Precautions, Immunization (5.10) Warnings and Precautions, Laboratory Monitoring (5.11) Warnings and Precautions, Use in RA Patients Who Have Not Had Prior IR to TNF antagonists (5.13) 01/2010 10/2009 01/2010 01/2010 10/2009 10/2009 10/2009 01/2010 01/2010 09/2009 01/2010 10/2009 ---------------------------INDICATIONS AND USAGE------------------------ Rituxan is a CD20-directed cytolytic antibody indicated for the treatment of patients with: ? Non-Hodgkin’s Lymphoma (NHL) (1.1) ? Chronic Lymphocytic Leukemia (CLL) (1.2) ? Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-t