It is a CD20-directed cytolytic antibody indicated for the treatment of patients with: ? Non-Hodgkin’s Lymphoma (NHL). ? Chronic Lymphocytic Leukemia (CLL) . ? Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies Limitations of Use: It is not recommended for use in patients with severe,active infections.
Cytotoxic immunosuppressants
Rituximab is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab has an approximate molecular weight of 145 kD. Rituximab has a binding affinity for the CD20 antigen of approximately 8.0 nM.
DO NOT ADMINISTER AS AN IV PUSH OR BOLUS. ? The dose for NHL is 375 mg/m2 . ? The dose for CLL is 375 mg/m2 in the first cycle and 500 mg/m2 in cycles 2?6,in combination with FC,administered every 28 days. ? The dose as a component of Zevalin? (Ibritumomab tiuxetan) Therapeutic Regimen is 250 mg/m2. ? The dose for RA in combination with methotrexate is two-1000 mg IV infusions separated by 2 weeks (one course) every 24 weeks or based on clinical evaluation,but not sooner than every 16 weeks. Methylprednisolone 100 mg IV or equivalent glucocorticoid is recommended 30 minutes prior to each infusion
Formal drug interaction studies have not been performed with Rituximab. In patients with CLL, Rituximab did not alter systemic exposure to fludarabine or cyclophosphamide.
Lymphoid Malignancies: Common side effects (?25%) in clinical trials of NHL were: infusion reactions,fever,lymphopenia,chills, infection and asthenia. Common side effects (?25%) in clinical trials of CLL were: infusion reactions and neutropenia . ? Rheumatoid Arthritis (RA) - side effects (?10%) in clinical trials: upper respiratory tract infection,nasopharyngitis,urinary tract infection,and bronchitis . Other important adverse reactions include infusion reactions,serious infections,and cardiovascular events .
Pregnancy: Limited human data; B-cell lymphocytopenia occurred in infants exposed in utero . ? Nursing Mothers: Caution should be exercised when administered to a nursing woman.
There has been no experience with overdosage in human clinical trials. Single doses of up to
500 mg/m2 have been administered in clinical trials.
Store the vial in original carton at 2°C-8°C in a refrigerator. Do not freeze. Protect from light. Keep out of the reach of children.
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