Recombinant factor IX Fc for major surgery in hemophilia B: factor IX plasma activity levels and effective hemostasis.
factor IX
hemophilia B
hemostasis
recombinant fusion proteins
surgery
Journal
Research and practice in thrombosis and haemostasis
ISSN: 2475-0379
Titre abrégé: Res Pract Thromb Haemost
Pays: United States
ID NLM: 101703775
Informations de publication
Date de publication:
Aug 2023
Aug 2023
Historique:
received:
02
03
2023
revised:
22
06
2023
accepted:
14
07
2023
medline:
11
9
2023
pubmed:
11
9
2023
entrez:
11
9
2023
Statut:
epublish
Résumé
Major surgical procedures are associated with significant bleeding risk and infectious complications in patients with hemophilia, which may be minimized by factor replacement. Monitoring perioperative factor levels guides dosing to maintain adequate levels for hemostatic control. We report prospectively collected post hoc surgical data in patients with hemophilia B who underwent major surgery with extended half-life recombinant factor IX Fc fusion protein (rFIXFc) in phase 3 studies (B-LONG/Kids B-LONG and B-YOND). Achieved FIX plasma levels were described for those who underwent major surgeries with ≥1 peak and/or predose FIX assessment available on the day of surgery (Day 0 [D0]) from the central laboratory. Dosing, injection frequency, adverse events, and hemostatic responses were assessed. Two representative cases were described further including blood loss, transfusions, and concomitant medication assessment. Of 35 major surgeries, 17 ( The aggregate analysis and representative cases of major surgeries demonstrate that rFIXFc can achieve FIX levels for effective hemostasis during invasive high-risk procedures.
Sections du résumé
Background
UNASSIGNED
Major surgical procedures are associated with significant bleeding risk and infectious complications in patients with hemophilia, which may be minimized by factor replacement. Monitoring perioperative factor levels guides dosing to maintain adequate levels for hemostatic control.
Objectives
UNASSIGNED
We report prospectively collected post hoc surgical data in patients with hemophilia B who underwent major surgery with extended half-life recombinant factor IX Fc fusion protein (rFIXFc) in phase 3 studies (B-LONG/Kids B-LONG and B-YOND).
Methods
UNASSIGNED
Achieved FIX plasma levels were described for those who underwent major surgeries with ≥1 peak and/or predose FIX assessment available on the day of surgery (Day 0 [D0]) from the central laboratory. Dosing, injection frequency, adverse events, and hemostatic responses were assessed. Two representative cases were described further including blood loss, transfusions, and concomitant medication assessment.
Results
UNASSIGNED
Of 35 major surgeries, 17 (
Conclusion
UNASSIGNED
The aggregate analysis and representative cases of major surgeries demonstrate that rFIXFc can achieve FIX levels for effective hemostasis during invasive high-risk procedures.
Identifiants
pubmed: 37694269
doi: 10.1016/j.rpth.2023.102169
pii: S2475-0379(23)00221-2
pmc: PMC10491823
doi:
Types de publication
Journal Article
Langues
eng
Pagination
102169Informations de copyright
© 2023 The Authors.
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