Rituximab-Arrx (1 brand name, 1 dosage form, 1 route)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION.
Brand Names
- RIABNI
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-arrx 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.