Rituxan® (rituximab) is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated CD20-positive Chronic Lymphocytic Leukemia

INN:

Subtype:

Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (CLL/SLL)

License:

FDA

Class:

CD20 monoclonal antibody

Newly Diagnosed

PI: https://www.gene.com/download/pdf/rituxan_prescribing.pdf 

1. Approved Labelling
Rituxan® (rituximab) is indicated, in combination with fludarabine and cyclophosphamide (FC), for the treatment of patients with previously untreated CD20-positive Chronic Lymphocytic Leukemia.


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.

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 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2-6 (every 28 days). 

3. AE/Warnings
Please see section 5 of the PI.

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