RT Journal Article
T1 Clinical Efficacy and Safety of Fanhdi®, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study.
A1 Jimenez-Yuste, Victor
A1 Alvarez-Roman, Maria Teresa
A1 Palomo-Bravo, Angeles
A1 Galmes, Bernardo J
A1 Nieto-Hernandez, Maria Del Mar
A1 Benitez-Hidalgo, Olga
A1 Marzo-Alonso, Cristina
A1 Perez-Gonzalez, Noelia Florencia
A1 Coll, Julia
A1 Nuñez, Ramiro
A1 Carrasco, Marina
A1 Garcia-Candel, Faustino
A1 Gonzalez-Porras, Jose Ramon
A1 Hernandez-Garcia, Carmen
A1 Varo-Castro, Maria Jose
A1 Mir, Roser
K1 Bleeding
K1 Plasma-derived von willebrand factor/factor VIII concentrate
K1 Prophylaxis
K1 Surgery
K1 Von willebrand disease
K1 Von willebrand factor
AB 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. 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. 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.
PB Sage Publishing
YR 2022
FD 2022-01-02
LK http://hdl.handle.net/10668/20220
UL http://hdl.handle.net/10668/20220
LA en
NO Jiménez-Yuste V, Alvarez-Román MT, Palomo Bravo Á, Galmes BJ, Nieto Hernández MDM, Benítez Hidalgo O, et al. Clinical Efficacy and Safety of Fanhdi®, a Plasma-Derived VWF/Factor VIII Concentrate, in von Willebrand Disease in Spain: A Retrospective Study. Clin Appl Thromb Hemost. 2022 Jan-Dec;28:10760296221074348
DS RISalud
RD Apr 9, 2025