Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization
Methods This is a retrospective study. G-CSF was administered in the dose of 10 μg/kg subcutaneous as a single dose for 4 days. On day 5, peripheral blood stem cell (PBSC) apheresis was performed using Haemonetics MCS plus or COBE Spectra apheresis machine through a double-lumen central venous cathe...
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2021-09-01
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doaj-585687e5121542988ddd5976fc6231422021-09-04T22:31:01ZengThieme Medical and Scientific Publishers Pvt. Ltd.South Asian Journal of Cancer2278-330X2278-43062021-09-0110.1055/s-0041-1729446Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation MobilizationSadik Husian0Preethi Jeyaraman1S. K. Gupta2Reeta Rai3Sangeeta Pathak4Nitin Dayal5Rahul Naithani6Department of Pharmacology, Pharmaceutical Sciences and Research University, New Delhi, IndiaDivision of Hematology and Bone Marrow Transplant, Saket, New Delhi, IndiaDepartment of Pharmacology, Pharmaceutical Sciences and Research University, New Delhi, IndiaDivision of Transfusion Medicine, Department of Lab Medicine Transfusion Medicine, Max Super Specialty Hospital, Saket, New Delhi, IndiaDivision of Transfusion Medicine, Department of Lab Medicine Transfusion Medicine, Max Super Specialty Hospital, Saket, New Delhi, IndiaDepartment of Lab Medicine, Max Super Specialty Hospital, Saket, New Delhi, IndiaDivision of Hematology and Bone Marrow Transplant, Saket, New Delhi, IndiaMethods This is a retrospective study. G-CSF was administered in the dose of 10 μg/kg subcutaneous as a single dose for 4 days. On day 5, peripheral blood stem cell (PBSC) apheresis was performed using Haemonetics MCS plus or COBE Spectra apheresis machine through a double-lumen central venous catheter. Primary outcome parameters were the total number of CD34+ HSCs/kg of recipient weight mobilized in peripheral blood and the number of days required for neutrophil and platelets engraftment, respectively. Objective We compared the effectiveness and safety of innovator filgrastim versus generic filgrastim in patients who underwent hematopoietic stem cell transplantation (HSCT). Results A total of 91 stem cell mobilizations was analyzed. There were 58 normal healthy donors for allogeneic HSCT and 33 patients for autologous HSCT. There was no statistically significant difference among groups in terms of total collected CD34+ cells value (p = 0.609). The mean time to neutrophil engraftment was 13.7 days in the innovator group and 13.2 days in the Grafeel group (p = 0.518). The mean time to platelet engraftment was 16.2 days in the innovator group and 14.8 days in the generic group (p = 0.435). The patient who received generic filgrastim had more febrile episodes during the course of transplantation (p = 0.020). Conclusion Generic filgrastim was found to be comparable to original filgrastim for peripheral blood stem cell mobilization in normal healthy donors for allogeneic HSCT and patients for autologous HSCT.http://www.thieme-connect.de/DOI/DOI?10.1055/s-0041-1729446bone marrow transplantcd34granulocyte colony-stimulating factormobilization |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Sadik Husian Preethi Jeyaraman S. K. Gupta Reeta Rai Sangeeta Pathak Nitin Dayal Rahul Naithani |
spellingShingle |
Sadik Husian Preethi Jeyaraman S. K. Gupta Reeta Rai Sangeeta Pathak Nitin Dayal Rahul Naithani Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization South Asian Journal of Cancer bone marrow transplant cd34 granulocyte colony-stimulating factor mobilization |
author_facet |
Sadik Husian Preethi Jeyaraman S. K. Gupta Reeta Rai Sangeeta Pathak Nitin Dayal Rahul Naithani |
author_sort |
Sadik Husian |
title |
Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization |
title_short |
Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization |
title_full |
Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization |
title_fullStr |
Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization |
title_full_unstemmed |
Innovator Filgrastim versus Generic Filgrastim in Hematopoietic Stem Cell Transplantation Mobilization |
title_sort |
innovator filgrastim versus generic filgrastim in hematopoietic stem cell transplantation mobilization |
publisher |
Thieme Medical and Scientific Publishers Pvt. Ltd. |
series |
South Asian Journal of Cancer |
issn |
2278-330X 2278-4306 |
publishDate |
2021-09-01 |
description |
Methods This is a retrospective study. G-CSF was administered in the dose of 10 μg/kg subcutaneous as a single dose for 4 days. On day 5, peripheral blood stem cell (PBSC) apheresis was performed using Haemonetics MCS plus or COBE Spectra apheresis machine through a double-lumen central venous catheter. Primary outcome parameters were the total number of CD34+ HSCs/kg of recipient weight mobilized in peripheral blood and the number of days required for neutrophil and platelets engraftment, respectively.
Objective We compared the effectiveness and safety of innovator filgrastim versus generic filgrastim in patients who underwent hematopoietic stem cell transplantation (HSCT).
Results A total of 91 stem cell mobilizations was analyzed. There were 58 normal healthy donors for allogeneic HSCT and 33 patients for autologous HSCT. There was no statistically significant difference among groups in terms of total collected CD34+ cells value (p = 0.609). The mean time to neutrophil engraftment was 13.7 days in the innovator group and 13.2 days in the Grafeel group (p = 0.518). The mean time to platelet engraftment was 16.2 days in the innovator group and 14.8 days in the generic group (p = 0.435). The patient who received generic filgrastim had more febrile episodes during the course of transplantation (p = 0.020).
Conclusion Generic filgrastim was found to be comparable to original filgrastim for peripheral blood stem cell mobilization in normal healthy donors for allogeneic HSCT and patients for autologous HSCT. |
topic |
bone marrow transplant cd34 granulocyte colony-stimulating factor mobilization |
url |
http://www.thieme-connect.de/DOI/DOI?10.1055/s-0041-1729446 |
work_keys_str_mv |
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