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Long-Term Real-World Post-approval Safety Data of Multiple Biosimilars from One Marketing-Authorization Holder After More than 18 Years Since Their First Biosimilar Launch.
Drug Saf
December 2023
Sandoz Inc, Princeton, NJ, USA.
Article Synopsis
- Biosimilars are approved treatment options based on comparisons to reference biologics, but concerns about their long-term safety remain, prompting a review of data from eight Sandoz biosimilars over up to 18 years.
- Cumulative exposure data showed over 1.3 billion patient treatment days for seven biosimilars and 1.8 million doses for one, indicating significant real-world use.
- The analysis concluded that the overall benefit-risk profiles of these Sandoz biosimilars are favorable and consistent with their reference biologics.
Effectiveness of single-dose 6 mg pegfilgrastim in mobilizing peripheral blood stem cells in allogeneic hematopoietic cell transplantation donors.
Ann Hematol
December 2023
Department of Hematology, The Affiliated People's Hospital of Ningbo University, Ningbo, China.
A single injection of 12 mg pegfilgrastim was used to mobilize peripheral blood progenitor cells (PBPCs) from healthy donors in some studies. The purpose of this study was to determine if 6 mg of pegfilgrastim was effective and safe for mobilizing CD34+ cells in donors for allogeneic hematopoietic stem cell transplantation. We conducted a retrospective case-matched design.
View Article and Find Full Text PDFComparison of 18 F-FDG PET Findings of Pegfilgrastim-Induced Aortitis With Other Types of Large-Vessel Vasculitis : A Retrospective Observational Study.
Clin Nucl Med
December 2023
From the Departments of Radiology.
Purpose Of The Report: To elucidate the PET/CT findings of pegfilgrastim-induced aortitis (PFIA) and compare them with those of other large-vessel vasculitis.
Methods: We enrolled 45 patients diagnosed with the following: PFIA, n = 8; Takayasu arteritis (TA), n = 12; giant cell arteritis (GCA), n = 6; and immunoglobulin G4-related aortitis (IgG4-A), n = 19. Records of PET/CT performed before treatment initiation were collected.
Dexamethasone dose-dependently prevents taxane-associated acute pain syndrome in breast cancer treatment.
Support Care Cancer
June 2023
Department of Pharmacy, Hokkaido University Hospital, Kita 14-Jo, Nishi 5-Chome, Kita-Ku, Sapporo, 060-8648, Japan.
Purpose: Taxane-associated acute pain syndrome (T-APS) is one of the most bothersome adverse effects caused by taxanes. We have previously reported the attenuating effect of dexamethasone (DEX) on T-APS and its risk factors under DEX prophylaxis. However, the appropriate DEX dosage administration remains unclear.
View Article and Find Full Text PDFCost comparison of filgrastim versus pegfilgrastim and pegfilgrastim biosimilars for inpatient prophylaxis of febrile neutropenia.
J Oncol Pharm Pract
October 2023
Department of Pharmacy, The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, Columbus, OH, USA.
Introduction: The Ohio State University Comprehensive Cancer Center (The James) uses daily subcutaneous filgrastim as the inpatient granulocyte colony-stimulating factor of choice. The coordination of care associated with filgrastim can often be a barrier to patient discharge. The purpose of this study was to compare the inpatient cost of daily filgrastim to single dose pegfilgrastim and biosimilars.
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