Rituxan (rituximab) is indicated for the treatment of patients with previously untreated Follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma in combination with first line chemotherapy, as a single-agent maintenance therapy.
Follicular Lymphoma (FL)
CD20 monoclonal antibody
1. Approved Labelling
Rituxan (rituximab) is indicated for the treatment of patients with previously untreated Follicular, CD20-positive, B-cell Non-Hodgkin Lymphoma in combination with first line chemotherapy, as a single-agent maintenance therapy.
2. Treatment Regimen
Premedicate before each infusion. Administer only as an intravenous (IV) infusion. Do not administer as an intravenous push or bolus.
First 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.
Subsequent Infusions: 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.
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 when administering the remainder of the treatment regimen (through Cycle 6 or 8).
Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count ≥5000/mm3 before Cycle 2 should not be administered the 90-minute infusion.
Interrupt the infusion or slow the infusion rate for infusion reactions. Continue the infusion at one-half the previous rate upon improvement of symptoms.
The recommended dose is 375 mg/m2 as an intravenous infusion.
Administer on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate Rituxan maintenance eight weeks following completion of Rituxan in combination with chemotherapy. Administer Rituxan as a single-agent every 8weeks for 12 doses.
Please see section 5 of the PI.
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