Rituximab (2 brand names, 1 dosage form, 2 routes)
Available dosage forms: SOLUTION.
Routes of administration: SUBCUTANEOUS, INTRAVENOUS.
Brand Names
- RITUXAN
- RITUXAN HYCELA
Boxed Warning
Infusion-Related ReactionsAdministration of rituximab products can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue RUXIENCE infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions [see Warnings and Precautions (5.1), Adverse Reactions (6.1)]. Severe Mucocutaneous ReactionsSevere, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products [see Warnings and Precautions (5.2)]. Hepatitis B Virus (HBV) ReactivationHBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with RUXIENCE. Discontinue RUXIENCE and concomitant medications in the event of HBV reactivation [see Warnings and Precautions (5.3)]. Progressive Multifocal Leukoencephalopathy (PML)Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products [see Warnings and Precautions (5.4), Adverse Reactions (6.3)].
Contraindications
None.
Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: •Infusion-related reactions [see Warnings and Precautions (5.1)] •Severe mucocutaneous reactions [see Warnings and Precautions (5.2)] •Hepatitis B reactivation with fulminant hepatitis [see Warnings and Precautions (5.3)] •Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.4)] •Tumor lysis syndrome [see Warnings and Precautions (5.5)] •Infections [see Warnings and Precautions (5.6)] •Cardiovascular adverse reactions [see Warnings and Precautions (5.7)] •Renal toxicity [see Warnings and Precautions (5.8)] •Bowel obstruction and perforation [see Warnings and Precautions (5.9)]
Drug Interactions
Formal drug interaction studies have not been performed with rituximab products. In patients with CLL, rituximab did not alter systemic exposure to fludarabine or cyclophosphamide. In clinical trials of patients with RA, concomitant administration of methotrexate or cyclophosphamide did not alter the pharmacokinetics of rituximab.
Mechanism of Action
Rituximab-pvvr is a monoclonal antibody. Rituximab products target the CD20 antigen expressed on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab products mediate B-cell lysis. Possible mechanisms of cell lysis include complement dependent cytotoxicity (CDC) and antibody dependent cell mediated cytotoxicity (ADCC). B cells are believed to play a role in the pathogenesis of rheumatoid arthritis (RA) and associated chronic synovitis. In this setting, B cells may be acting at multiple sites in the autoimmune/inflammatory process, including through production of rheumatoid factor (RF) and other autoantibodies, antigen presentation, T-cell activation, and/or proinflammatory cytokine production.