Rituxan (rituximab) is indicated for the treatment of patients with Relapsed or Refractory, low-grade or Follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma as a single agent.

INN:

Subtype:

Follicular Lymphoma (FL)

License:

FDA

Class:

CD20 monoclonal antibody

R/R

PIhttps://www.gene.com/download/pdf/rituxan_prescribing.pdf 

1. Approved Labelling 

Rituxan (rituximab) is indicated for the treatment of patients with Relapsed or Refractory, low-grade or Follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma as a single agent.

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 once weekly for 4 or 8 doses.

3. AE/Warnings

Please see section 5 of the PI.



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