Recombinant factor IX Fc for major surgery in hemophilia B: factor IX plasma activity levels and effective hemostasis.

ABSTRACT:

Background

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

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

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,

SUBMITTER: Shapiro AD 

PROVIDER: S-EPMC10491823 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature