Administration only as an Intravenous Infusion: It should not be administered as an intravenous push or bolus. Rituximab should only be administered by a healthcare professional with appropriate medical support to manage severe infusion-related reactions that can be fatal if they occur. It should be premedicated before each infusion, or as directed by the registered physicians.
First Infusion: Standard Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr.
For Pediatric Patients with mature B-cell NHL/B-AL: Initiate infusion at a rate of 0.5 mg/kg/hr (maximum 50 mg/hr). In the absence of infusion toxicity, increase infusion rate by 0.5 mg/kg/hr every 30 minutes, to a maximum of 400 mg/hr.
Subsequent Infusions: Standard Infusion: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr.
For Previously Untreated Follicular NHL and DLBCL adult patients: If patients did not experience a Grade 3 or 4 infusion-related adverse event during Cycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen. Initiate at a rate of 20% of the total dose given in the first 30 minutes and the remaining 80% of the total dose given over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used through Cycle 6 or 8. Patients with clinically significant cardiovascular disease or circulating lymphocyte count ≥5,000/mm³ before Cycle 2 should not receive the 90-minute infusion.
Recommended Dose for Non-Hodgkin’s Lymphoma (NHL): The recommended dose is 375 mg/m² as an intravenous infusion. Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive B-Cell NHL: once weekly for 4 or 8 doses. Retreatment for Relapsed or Refractory NHL: once weekly for 4 doses. Previously Untreated Follicular NHL: Day 1 of each chemotherapy cycle up to 8 doses; then maintenance every 8 weeks for 12 doses. Non-progressing Low-Grade NHL after CVP: once weekly for 4 doses at 6-month intervals up to 16 doses. Diffuse Large B-Cell NHL: Day 1 of each chemotherapy cycle up to 8 infusions.
Pediatric patients (6 months and older) with mature B-cell NHL/B-AL: Six total infusions with LMB chemotherapy (COPDAM1, COPDAM2, CYM/CYVE).
Recommended Dose for Chronic Lymphocytic Leukemia (CLL): 375 mg/m² the day prior to FC chemotherapy, then 500 mg/m² on Day 1 of cycles 2–6 (every 28 days).
Recommended Dose for Rheumatoid Arthritis (RA): Two 1,000 mg IV infusions separated by 2 weeks. Methylprednisolone 100 mg IV 30 minutes prior to each infusion is recommended. Subsequent courses every 24 weeks or based on evaluation (not sooner than 16 weeks). Given with methotrexate.
Recommended Dose for GPA and MPA: 375 mg/m² IV once weekly for 4 weeks with glucocorticoids (methylprednisolone 1,000 mg/day for 1–3 days, then oral prednisone).
Recommended Dose for Pemphigus Vulgaris (PV): Two 1,000 mg IV infusions separated by 2 weeks with tapering glucocorticoids.
Maintenance treatment: 500 mg IV at Month 12 and every 6 months thereafter or based on evaluation.
Treatment of relapse: 1,000 mg IV at relapse; consider glucocorticoid adjustment. Subsequent infusions no sooner than 16 weeks.
