to receive rituximab, 375 mg/m2 intravenousinfusion, once weekly for 4 doses every 6 months for up to 16 doses or no further therapeuticintervention. The main outcome measure of the study was progression-free survival defined asthe time from randomization to progression, relapse, or death. Thirty-seven percent of the studypopulation was >60 years of age, 99% had Stage III or IV disease, and 63% had an IPI score≥2.
There was a reduction in the risk of progression, relapse, or death (hazard ratio estimate in therange of 0.36 to 0.49) for patients randomized to rituximab as compared to those who receivedno additional treatment.
14.3 Ninety-Minute Infusions in Previously Untreated Follicular NHL and Another
Indication
In Study 10, patients with previously untreated follicular NHL (n=113) or another indication(n=250) were eva luated in a prospective, open-label, multi-center, single-arm trial for the safetyof 90-minute rituximab infusions. Patients with follicular NHL received rituximab 375 mg/m2plus CVP chemotherapy. Patients with another indication received rituximab 375 mg/m2 plusother chemotherapy agents. Patients with clinically significant cardiovascular disease wereexcluded from the study. Patients were eligible for a 90-minute infusion at Cycle 2 if they didnot experience a Grade 3-4 infusion-related adverse event with Cycle 1 and had a circulating
lymphocyte count ≤ 5000/mm3 before Cycle 2. All patients were pre-medicated withacetaminophen and an antihistamine and received the glucocorticoid component of their
chemotherapy prior to rituximab infusion. The main outcome measure was the development ofGrade 3-4 infusion reactions on the day of, or day after, the 90-minute infusion at Cycle 2 [seeAdverse Reactions (6.1)].
Eligible patients received their Cycle 2 rituximab infusion over 90 minutes as follows: 20% ofthe total dose given in the first 30 minutes and the remaining 80% of the total dose given overthe next 60 minutes [see Dosage and Administration (2.1)].
Patients who tolerated the 90minute rituximab infusion at Cycle 2 continued to receivesubsequent rituximab infusions atthe 90-minute infusion rate for the remainder of the treatment regimen (through Cycle 6 orCycle 8).
The incidence of Grade 3-4 infusion reactions at Cycle 2 was 1.1% (95% CI [0.3%, 2.8%])among all patients, 3.5% (95% CI [1.0%, 8.8%]) for those patients treated with R-CVP, and 0.0%(95% CI [0.0%, 1.5%]) for those patients treated with rituximab and other chemotherapy agents.
For Cycles 2-8, the incidence of Grade 3-4 infusion reactions was 2.8% (95% CI [1.3%, 5.0%]).
No acute fatal infusion reactions were observed.
16 HOW SUPPLIED/STORAGE AND HANDLING
TRUXIMA (rituximab-abbs) injection is a sterile, clear to opalescent, colorless to paleyellow, preservative-free solution for intravenous infusion supplied as a carton containingone 100 mg/10 mL (10 mg/mL) single-dose vial (NDC 63459-103-10) or a cartoncontaining one 500 mg/50 mL (10 mg/mL) single-dose vial (NDC 63459-104-50).
Store TRUXIMA vials refrigerated at 2°C to 8°C (36°F to 46°F). TRUXIMA vials shouldbe protected from direct sunlight. Do not freeze or shake.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Infusion Reactions
Inform patients about the signs and symptoms of infusion reactions. Advise patients to contacttheir healthcare provider immedia |
