Observational Safety Study of Clottafact((R)) Fibrinogen Concentrate: Real-World Data in Mexico

Authors: Colin-Bracamontes, I., Perez-Calatayud, A. A., Carrillo-Esper, R., Rodriguez-Ayala, E., Padilla-Molina, M., Posadas-Nava, A., Olvera-Vazquez, S., and Hernandez-Salgado, L.

Publication: Clin Drug Investig; March 2020

Affiliations: LFB Mexico and Anahuac Mexico University, 243 Paseo de la Reforma Avenue, Floor 23, 06500, Mexico City, Mexico; Intensive Therapy Unit/Children in Mexico s General Hospital, Mexico City, Mexico; Mexican Academy of Surgery, National Rehabilitation Institute, Mexican Group for the Intensive Medicine Study, National Academy of Medicine, Mexico City, Mexico; Anahuac Mexico University, Huixquilucan, Mexico City, State of Mexico, Mexico; Council for Gender Equality, Chihuahua, Mexico; High Specialty Medical Unit of Obstetrics and Gynecology, IMSS, Mexico City, Mexico; Strategy and Regulatory Science, LFB Mexico, Mexico City, Mexico; Pharmacovigilance Coordination Department, Innovare R&D, Mexico City, Mexico.

Abstract: BACKGROUND AND OBJECTIVE: The use of fibrinogen concentrate to treat or prevent major bleeding with regard to potential adverse reactions has not been free of controversy. Our objective was to perform a post-authorization safety study to describe the use of Clottafact((R)) (LFB Biomedicaments) fibrinogen concentrate in real-life medical practice in Mexico. METHODS: This was a prospective, observational study that collected and evaluated information between January 2017 and June 2019 related to suspected serious adverse reactions (SUSARs) during and after Clottafact((R)) infusion. RESULTS: Information from 40 subjects was analyzed; 43% were women (n = 17), mean age was 39.05 +/- 26.8 years (range 0-91 years). The medical specialties included in this analysis were cardiac surgery – 52.5% of the cases, gynecology/obstetrics – 17.5%, general surgery and orthopedics – 12.5% each, and hematology and neurosurgery – 2.5%, respectively. Mean plasma fibrinogen levels before and after Clottafact((R)) infusion were 2.58 g/L and 4.02 g/L; p = 0.001, respectively. The mean Clottafact((R)) dose was 2.20 +/- 0.77 g. One patient presented SUSARs (dry mouth and dysgeusia) with drug administration, which ceased after treatment discontinuation. CONCLUSIONS: In this real-life post-marketing study, the safety profile of Clottafact((R)) was very similar to previous reports. Thus, Clottafact((R)) shows a favorable safety profile in clinical practice.