A RANDOMIZED, MULTIPLE-DOSE, MULTICENTER, COMPARATIVE PARALLEL STUDY TO EVALUATE THE PHARMACOKINETIC CHARACTERISTICS OF INTRAVENOUS INFUSION OF RITUXIMAB (HETERO) AND REFERENCE MEDICINAL PRODUCT (RITUXIMAB, ROCHE) IN INDIAN PATIENTS OF NON-HODGKIN'S LYMPH

Dr Shubhadeep Sinha*, Mr Bala Reddy, Mr Vamsi Krishna Bandi, Dr Pankaj Thakur*, Dr Neetu Naidu and Dr Sreenivasa Chary

ABSTRACT

Aim: To evaluate the pharmacokinetic characteristics of two formulations of Rituximab (test and reference) at 1st & 6th cycles (steady state) of chemotherapy. Methods: A total of 135 Diffuse Large B-cell Lymphoma (DLBCL) patients were randomized to receive intravenous infusion of either test or reference product. Pharmacokinetic assessment was done for 50 DLBCL patients. Serial PK samples were collected during cycle one (pre and post infusion) and cycle six (pre and post infusion) of chemotherapy. Cmax, Tmax, AUC0-t, and AUC0-22d, were assessed for both the cycles. Results: Values of Cmax (ng/ml) for test 322572.416 ± 112718.8714 and reference 294696.340 ± 83273.4206, Tmax (hours) for test 4.583 (2.000 - 507.600) and reference 4.350 (2.000-507.933), AUC0-t, and AUC0-22d were comparable for both cycle one after single dose administration and at steady state in cycle six of test product and reference medicinal product in DLBCL patients. Conclusion: The pharmacokinetic parameters of both test and reference products of Rituximab were found to be comparable in patients of Non-Hodgkin’s lymphomas (viz; DLBCL) treated with R-CHOP.

Keywords: Rituximab, Non-Hodgkin’s Lymphoma, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma.