Search results for "Turoctocog alfa"
showing 3 items of 3 documents
The Effect of Fluctuating Temperature on the Stability of Turoctocog Alfa for Hemophilia A
2019
Abstract Background and objective Factor VIII (FVIII) is indicated for the prevention or treatment of bleeding in patients with hemophilia A. FVIII product stability under high and fluctuating temperatures is important, particularly for patients who reside in, or travel to, regions with high ambient temperatures, as they may remove their product from the refrigerator and return it, unused, multiple times. We evaluated the effect of variable temperature storage conditions, including up to 40 °C, on the stability of the recombinant FVIII product, turoctocog alfa. Methods Turoctocog alfa dry powder stability was assessed when moved between storage conditions of 5 °C (ambient humidity) and 40 °…
Status of Recombinant Factor VIII Concentrate Treatment for Hemophilia A in Italy: Characteristics and Clinical Benefits
2019
The current interest in recombinant factor VIII (rFVIII) products stems from the fact that they offer a technological solution to prolonging the half-life of and reducing the risk of formation of alloantibodies (inhibitors) against FVIII in treated patients with hemophilia A (HA). The Italian health care system has authorized the use of a wide range of rFVIII concentrates of the first, second, and third generation, as well as new innovative rFVIII preparates with an extended half-life (EHL) (Kogenate FS®-Bayer, belonging to the second generation and replaced since 2017 by a product consisting of the same modified molecule; because it is only available until the end of the current year, it w…
Recombinant FVIII Products (Turoctocog Alfa and Turoctocog Alfa Pegol) Stable Up to 40°C
2021
Mariasanta Napolitano,1 Arne Agerlin Olsen,2 Anne Mette Nøhr,2 Hermann Eichler3 1Department of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), University of Palermo Reference Regional Center for Thrombosis and Hemostasis, Hematology Unit, Palermo, Italy; 2Novo Nordisk A/S, Biopharm Manufacturing Development, Gentofte, Denmark; 3Saarland University and Saarland University Hospital, Institute of Clinical Haemostaseology and Transfusion Medicine, Homburg (Saar), GermanyCorrespondence: Anne Mette NøhrBiopharm Manufacturing Development, Novo Nordisk A/S, Nybrovej 80, Gentofte 2820, DenmarkTel +45 3075 1619Email amnq@novonordisk.…