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U.S. Department of Health and Human Services

Drugs

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Rituximab Infusion

On October 19, 2012, the U. S. Food and Drug Administration approved a 90-minute infusion for rituximab (Rituxan Injection, Genentech, Inc.) starting at Cycle 2 for patients with non-Hodgkin’s lymphoma (NHL) who did not experience a grade 3 or 4 infusion-related adverse reaction during Cycle 1.  Patients with clinically significant cardiovascular disease and high circulating lymphocyte counts (>5000/mcL) are not recommended to receive the faster infusion.

 
The approval was based on an open-label, single-arm, multi-center, phase 3 trial (RATE). The evaluable patient population was comprised of 363 previously untreated patients with follicular NHL or diffuse large B-cell lymphoma (DLBCL) who had not experienced a grade 3 or 4 infusion-related reaction (IRR) to rituximab in combination with CHOP or CVP chemotherapy during Cycle 1.  Patients received the faster infusion in Cycle 2 and, if tolerated, in all subsequent cycles.  The faster infusion regimen consisted of rituximab administered over 90 minutes with 20% of the total dose given in the first 30 minutes, and remaining 80% of the total dose administered over the subsequent 60 minutes.
 
The trial’s primary endpoint was the incidence of grade 3 and 4 IRRs in patients who received rituximab by faster infusion at Cycle 2. The incidence of grade 3 IRRs at Cycle 2 was 1.1% (95% CI: 0.3, 2.8)], with no grade 4 or 5 IRRs reported. The RATE trial results are comparable to the results of IRRs during cycle 2 reported from trials using the standard infusion regimen.
 
Full prescribing information is available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103705s5367s5388lbl.pdf 
 
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).