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Information about Rituximab

Rituximab is a chimeric mouse/human monoclonal antibody to CD20 a cell surface antigen found on pre-B and mature B lymphocytes and which is approved for use in non-Hodgkin lymphoma and chronic lymphocytic leukemia as well as in several autoimmune conditions, including rheumatoid arthritis and Wegener granulomatous

Liver safety of Rituximab

Rituximab has been linked to many cases of severe and even fatal liver injury as a result of reactivation of inactive or previously resolved hepatitis B.   

Mechanism of action of Rituximab

Rituximab (ri tux’ i mab) is a human mouse chimeric monoclonal immunoglobulin G1 antibody to the cell surface antigen CD20 (also known as human B lymphocyte restricted differentiation antigen: Bp35) which is found on mature B cells as well as 90% of B cell neoplasms such as non-Hodgkin lymphoma and chronic lymphocytic leukemia.  CD20 is not present on pro-B cells, hematopoietic stem cells, normal plasma cells or other normal lymphocytes, circulating cells or tissues.  Engagement of rituximab with CD20 leads to B cell lysis and depletion of circulating and tissue B cells for an extended period, up to 6 to 8 months.  There is an accompanying decrease in IgG and IgM levels, but in only 10% to 15% of patients do immunoglobulin levels fall below the normal range. 

FDA approval information for Rituximab

Rituximab was approved for use in non-Hodgkin lymphoma and chronic lymphocyte leukemia in the United States in 1997, and indications were subsequently expanded to severe autoimmune conditions including refractory rheumatoid arthritis and Wegener granulomatosis (granulomatosis with polyangiitis).  Rituximab is used off-label and is under active investigation in several other malignant conditions and autoimmune diseases.  Rituximab is available in liquid solution in single use vials of 100 and 500 mg (10 mg/mL) under the brand name Rituxan. 

FDA approval information for Rituximab

The dose and regimen varies by indication. 

Side effects of Rituximab

Common side effects include infusion reactions, chills, fever, skin rash, fatigue, leukopenia and infections.  Less common, but potentially severe side effects include cutaneous reactions (Stevens Johnson syndrome), infections, reactivation of tuberculosis, progressive multifocal leukoencephalopathy, cardiac arrhythmias, renal toxicity and bowel obstruction.  Because of the potential severity of infusion reactions, premedication with antihistamines and acetaminophen is recommended and rituximab should be administered under close medical observation.

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