Clinical efficacy and safety of fanhdi<sup>®</sup>, a plasma-derived VWF/Factor VIII concentrate, in von willebrand disease in Spain: a retrospective study
Author
Jiménez Yuste, Víctor Manuel

Entity
UAM. Departamento de MedicinaPublisher
SAGEDate
2022-01-02Citation
10.1177/10760296221074348
Clinical and Applied Thrombosis/Hemostasis 28 (2022): 1-11
ISSN
1076-0296 (print); 1938-2723 (online)DOI
10.1177/10760296221074348Funded by
The author(s) disclosed receipt of the followingfinancial support forthe research, authorship, and/or publication of this article: This workwas supported by Grifols, manufacturer of the pdVWF/FVIII,Fanhdi®Editor's Version
https://doi.org/10.1177/10760296221074348Subjects
bleeding; plasma-derived von willebrand factor/factor VIII concentrate; prophylaxis; surgery; von willebrand disease; von willebrand factor; MedicinaRights
© The Author(s) 2022Abstract
To evaluate the efficacy and safety of a plasma-derived factor VIII concentrate containing von Willebrand Factor (pdVWF/FVIII) in standard clinical practice in von Willebrand Disease (VWD) patients. Methods: A retrospective, multicentric, observational study of VWD patients treated with Fanhdi®, a pdVWF/FVIII concentrate, from January 2011 to December 2017 was conducted at 14 centers in Spain. Efficacy and safety were evaluated for acute bleeding episodes, for prevention of bleeding in surgeries, and for secondary long-term prophylaxis. Seventy-two eligible patients, type 1, 2, 3 VWD (25%/38.9%/36.1%) were treated for spontaneous and traumatic bleeding (140 episodes, n = 41 patients), to prevent surgical bleeding (69 episodes, n = 43 patients); and for secondary long-term prophylaxis (18 programs, n = 13 patients). Replacement therapy with pdVWF/FVIII showed an excellent to good clinical efficacy in 96.7% of the bleeding episodes, 100% during surgical procedures and 100% during prophylaxis. No adverse events (AEs), nor serious AEs related to the product were observed. Conclusions: Fanhdi® was effective, safe and well tolerated in the management of bleeding episodes, the prevention of bleeding during surgeries, and for secondary long-term prophylaxis in VWD patients
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Google Scholar:Jiménez Yuste, Víctor Manuel
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Álvarez Roman, María Teresa
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Palomo Bravo, Ángeles
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Galmes, Bernardo J.
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Nieto Hernández, Maria del Mar
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Benítez Hidalgo, Olga
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Marzo Alonso, Cristina
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Pérez González, Noelia Florencia
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Coll, Julia
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Núñez, Ramiro
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Carrasco, Marina
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García Candel, Faustino
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Gonzalez-Porras, Jose Ramon
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Hernández García, Carmen
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Varó Castro, Maria José
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Mir, Roser
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