A prospective study of filgrastim pharmacokinetics in morbidly obese patients compared with non-obese controls.
filgrastim
granulocyte colony-stimulating factor
obesity
pharmacokinetics
Journal
Pharmacotherapy
ISSN: 1875-9114
Titre abrégé: Pharmacotherapy
Pays: United States
ID NLM: 8111305
Informations de publication
Date de publication:
01 2022
01 2022
Historique:
revised:
19
10
2021
received:
24
08
2021
accepted:
21
10
2021
pubmed:
13
11
2021
medline:
29
1
2022
entrez:
12
11
2021
Statut:
ppublish
Résumé
Filgrastim is a human granulocyte colony-stimulating factor (G-CSF). There are limited data on dosing filgrastim in obesity. The objective of this study was to compare filgrastim pharmacokinetic parameters for morbidly obese and non-obese patients after a single subcutaneous dose of filgrastim dosed per actual body weight. This prospective, matched-pair study (NCT01719432) included patients ≥18 years of age, receiving filgrastim at 5 μg/kg with a weight >190% of their ideal body weight (IBW) for "morbidly obese" patients or within 80%-124% of IBW for matched-control patients. The control group was prospectively matched for age (within 10 years), degree of neutropenia, and gender. Filgrastim doses were not rounded to vial size, to allow more accurate assessment of exposure. Blood samples were collected at 0 (prior to dose), 2, 4, 6, 8, 12, and 24 h after the first subcutaneous administration of filgrastim. A total of 30 patients were enrolled in this prospective pharmacokinetic study, with 15 patients assigned to each arm. Non-compartmental analysis showed that the systemic clearance (Cl) was 0.111 ± 0.041 ml/min in the morbidly obese group versus 0.124 ± 0.045 ml/min in the non-obese group (p = 0.44). Additionally, the mean area under the curve (AUC Calculating subcutaneous filgrastim doses using actual body weight appears to produce similar systemic exposure in morbidly obese and non-obese patients with severe neutropenia.
Substances chimiques
Granulocyte Colony-Stimulating Factor
143011-72-7
Filgrastim
PVI5M0M1GW
Banques de données
ClinicalTrials.gov
['NCT01719432']
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
53-57Subventions
Organisme : NIGMS NIH HHS
ID : U54 GM104942
Pays : United States
Organisme : NIGMS NIH HHS
ID : P20 GM121322
Pays : United States
Informations de copyright
© 2021 Pharmacotherapy Publications, Inc.
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