Japanese Journal of Thrombosis and Hemostasis
Online ISSN : 1880-8808
Print ISSN : 0915-7441
ISSN-L : 0915-7441
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Volume 33, Issue 1
Displaying 1-17 of 17 articles from this issue
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Original article
  • Safety and effectiveness of albutrepenonacog alfa in Japanese patients with hemophilia B: Interim report of a post-marketing surveillance study
    Teruhisa FUJII, Keiji NOGAMI, Midori SHIMA, Hiromi TERAYAMA, Fumihiko ...
    Article type: Original article
    2022 Volume 33 Issue 1 Pages 60-68
    Published: 2022
    Released on J-STAGE: February 25, 2022
    DOIhttps://doi.org/10.2491/jjsth.33.60
    JOURNAL FREE ACCESS FULL-TEXT HTML
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    Albutrepenonacog alfa, a fusion protein that links recombinant coagulation factor IX (rFIX) with recombinant human albumin, was developed to prolong its half-life and reduce the number of administration, and was approved in Japan in 2016. This is a 4-year interim report of a post-marketing surveillance study in hemophilia B patients who received albutrepenonacog alfa. Of the patients included in the safety analysis set (n = 68), 64 patients used albutrepenonacog alfa for prophylaxis, 27 patients for on-demand therapy, five patients for perioperative bleeding control, and 13 patients for other reasons during observation period (including duplicates), and hemostasis was achieved with a single administration in six of eight cases in five patients for perioperative bleeding control. No safety concerns were observed during the observation period. In the prophylaxis effectiveness analysis set who continued prophylaxis for more than 6 months (n = 41), the median number of bleeding episodes was 0, and 24 patients (58.5%) received albutrepenonacog alfa at dosage intervals of 7 days at 6 months after the start of prophylaxis.

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