Eflapegrastim (Rolontis) is a long‐acting granulocyte colony‐stimulating factor (G‐CSF) produced by conjugating a human G‐CSF analogue and a human immunoglobulin G4 Fc fragment, linked via a polyethylene glycol linker. Weight‐based doses of ...
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https://www.riss.kr/link?id=O111279956
2021년
-
0091-2700
1552-4604
SCI;SCIE;SCOPUS
학술저널
204-210 [※수록면이 p5 이하이면, Review, Columns, Editor's Note, Abstract 등일 경우가 있습니다.]
0
상세조회0
다운로드다국어 초록 (Multilingual Abstract)
Eflapegrastim (Rolontis) is a long‐acting granulocyte colony‐stimulating factor (G‐CSF) produced by conjugating a human G‐CSF analogue and a human immunoglobulin G4 Fc fragment, linked via a polyethylene glycol linker. Weight‐based doses of ...
Eflapegrastim (Rolontis) is a long‐acting granulocyte colony‐stimulating factor (G‐CSF) produced by conjugating a human G‐CSF analogue and a human immunoglobulin G4 Fc fragment, linked via a polyethylene glycol linker. Weight‐based doses of 45 to 270 μg/kg eflapegrastim (12.3‐73.6 μg/kg as G‐CSF) were evaluated in a phase 2 study in patients. Based on these results, a fixed dose of 13.2 mg eflapegrastim (3.6 mg G‐CSF) was compared with pegfilgrastim (6 mg G‐CSF) in 2 phase 3 studies and in a pharmacokinetic single‐arm multicenter study. Absolute neutrophil count (ANC) data from these 3 studies were evaluated in patients with early‐stage breast cancer who were treated with docetaxel and cyclophosphamide (n = 669). Serum concentrations of eflapegrastim were determined by enzyme‐linked immunosorbent assay. Eflapegrastim systemic exposures were higher in cycle 1 than in cycle 3, likely attributable to the higher ANC in cycle 3, increasing neutrophil‐mediated clearance. Eflapegrastim elicited a greater effect on ANC than pegfilgrastim in patients at ∼60% of the G‐CSF dose. Body weight had no clinically significant effect on response, justifying administration of a fixed dose of eflapegrastim. The results from 2 phase 3 studies demonstrate that eflapegrastim at a fixed dose of 13.2 mg (3.6 mg G‐CSF) administered once per chemotherapy cycle is effective in prophylactic treatment of chemotherapy‐induced neutropenia.
Enhancing Pediatric Adverse Drug Reaction Documentation in the Electronic Medical Record