90-MINUTE RITUXAN INFUSION FOR APPROPRIATE PREVIOUSLY UNTREATED DLBCL AND FOLLICULAR NHL PATIENTS IN CYCLES 2-8

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.

The 90-minute RITUXAN infusion can be administered to patients who 1,2,7:
  • Have previously untreated DLBCL or follicular lymphoma, receiving R-CHOP or R-CVP, respectively
  • Are ≥18 years of age
  • Have an ECOG PS 0-2
  • Have a circulating lymphocyte count ≤5,000/µL at the start of Cycle 2
  • Did not experience any infusion-related serious adverse event (SAE) or Grade 3/4 infusion-related reaction (IRR) in Cycle 1
  • Do not have significant cardiovascular disease*
  • Patients in Stage 3 or 4 of DLBCL and follicular lymphoma were included in the RATE trial 7
  • All patients were premedicated with acetaminophen and an antihistamine prior to RITUXAN administration 1
  • Patients had a glucocorticoid component of R-CHOP or R-CVP administered prior to RITUXAN. No other glucocorticoids were allowed 1,7

*Per the RATE trial, clinically significant cardiovascular disease is defined as uncontrolled hypertension, myocardial infarction, or unstable angina; New York Heart Association (NYHA) Classification Grade II or greater congestive heart failure; a ventricular arrhythmia requiring medication within 1 year prior to Day 1; or NYHA Grade II or greater peripheral vascular disease on Day 1. 2

The 90-minute RITUXAN infusion rate for appropriate patients is 1:
  • 20% of the total dose over the first 30 minutes (75 mg/m2)
  • 80% of the total dose over the following 60 minutes (300 mg/m2)
  • 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)

†For standard infusions in Cycles 2-8, initiate 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. 1

Demonstrated Safety Profile With A 90-Minute Infusion In Cycles 2-8
  • Of the 425 patients treated with RITUXAN in Cycle 1, 85% (n=363) were able to receive the 90-minute infusion of RITUXAN in Cycle 2 1,7
  • Primary endpoint of the RATE trial was the incidence of Grade 3 or 4 IRRs the day of or the day after a 90-minute infusion of RITUXAN in Cycle 2 1‡
  • Incidence of Grade 3/4 IRRs in Days 1-2 of Cycle 2 was 1.1% 1
  • Incidence of Grade 3/4 IRRs was 2.8% cumulatively in Cycles 2-8 1
  • No fatal IRRs or fatal AEs on Days 1-2 of any cycle 2

IRRs were categorized as Grades 1 through 5, as defined by Common Terminology Criteria for Adverse Events (CTCAE) v3.0.

The RATE study did not enroll low-grade or follicular NHL post-induction or CLL patients. As such, there are no data in the RATE study that support using 90-minute RITUXAN infusion in these patients. 1,7

Infusion Reactions
  • RITUXAN can cause severe, including fatal, infusion reactions. Severe reactions typically occurred during the first infusion, with time to onset of 30 to 120 minutes
  • RITUXAN-induced infusion reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death
  • Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (eg, glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion reactions as needed. Depending on the severity of the infusion reaction and the required interventions, slow the infusion rate, interrupt the infusion, or permanently discontinue RITUXAN. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved
  • Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (≥25,000/mm 3)

DLBCL=diffuse large B-cell lymphoma; NHL=non-Hodgkin's lymphoma; R=RITUXAN; CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone; CVP=cyclophosphamide, vincristine, and prednisone; ECOG PS=Eastern Cooperative Oncology Group performance status; SAE=serious adverse event; IRR=infusion-related reaction; AE=adverse event; NCI=National Cancer Institute. 

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