Pharmacokinetic implications of dosing emicizumab based on vial size: A simulation study.
emicizumab
haemophilia
pharmacokinetics
Journal
Haemophilia : the official journal of the World Federation of Hemophilia
ISSN: 1365-2516
Titre abrégé: Haemophilia
Pays: England
ID NLM: 9442916
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
revised:
15
02
2021
received:
14
12
2020
accepted:
22
02
2021
pubmed:
3
3
2021
medline:
21
9
2021
entrez:
2
3
2021
Statut:
ppublish
Résumé
Emicizumab is dosed as mg/kg and, according to the label, any unused drug left in the vial(s) must be discarded, thereby wasting expensive resources. The aim of this study was to use population pharmacokinetics to illustrate the implications of changing the dosing interval to avoid wastage. We used a previously published emicizumab PopPK model after extending its validation to children. We simulated PK parameters for labelled dosing regimens and for regimens using full vials with infusion frequency varied to keep the steady-state drug concentration unchanged. Cost and drug savings were calculated. The model evaluation was successful. When rounding up, the average individual below 53, 47 and 39 has a time-to-trough increase of up to 5.7, 7.9 and 5.8 days for the QW, Q2 W and Q4 W regimen, respectively. This resulted in an annual cost reduction of up to $173,136, $75,747 and $61,319 USD per patient. At higher body weights, rounding down the dose to the nearest vial resulted in negligible changes in the steady state concentration and cost savings of up to $93,781, $46,891 and $23,446 USD per patient, respectively. Individuals with a lower body weight may benefit from increasing dose intervals and rounding up dose up to the nearest vial, and individuals with a higher body weight from maintaining the injection frequency and rounding dose down to the nearest vial without significant change in emicizumab levels. Administering the entire vial may result in a reduction of vials used annually and potential cost savings.
Substances chimiques
Antibodies, Bispecific
0
Antibodies, Monoclonal, Humanized
0
emicizumab
7NL2E3F6K3
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
358-365Informations de copyright
© 2021 John Wiley & Sons Ltd.
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