title: Pharmacokinetics, Safety, and Efficacy of Recombinant Factor VIII Fc Fusion Protein: A Practical Review.
abstract: Prophylaxis for hemophilia A with conventional factor VIII (FVIII) products requires frequent intravenous dosing, which may reduce adherence. Recombinant factor VIII Fc fusion protein (rFVIIIFc) has a prolonged half-life compared with conventional rFVIII, and has demonstrated safety and efficacy for the prevention and treatment of bleeding episodes in phase 3 studies of patients with severe hemophilia A. Most subjects experienced reduced prophylactic dosing frequency with rFVIIIFc compared with prestudy FVIII; the median total weekly prophylactic consumption was comparable. No subjects developed inhibitors. These results suggest that prophylaxis with rFVIIIFc in patients with hemophilia A may allow less frequent prophylactic dosing while maintaining efficacy, with comparable prophylactic consumption.
authors.affiliation: University of California at Davis, Sacramento, California (Ms Schafer); University of Michigan, Ann Arbor, Michigan (Mr Munn); Great Ormond Street Hospital for Children NHS Foundation Trust, London, United Kingdom (Dr Khair); Indiana Hemophilia and Thrombosis Center, Indianapolis, Indiana (Ms Thukral); and Biogen, Weston, Massachusetts (Ms Tom and Ms McAlister). Kim Schafer, MSN, RN, is the nurse coordinator at the UC Davis Hemophilia Treatment Center. She has 16 years of experience providing care for both adult and pediatric patients with inherited bleeding disorders. James Munn, MS, BSN is a program and nurse coordinator of the Hemophilia and Coagulation Disorders Program at the University of Michigan Health System. He currently chairs the World Federation of Hemophilia's Nurses Committee and is the treasurer of the Nursing Forum of the International Society on Thrombosis and Haemostasis. Kate Khair, PhD, SRN, RSCN, MSc, MCGI, is a consultant nurse and visiting professor in health and social care at Great Ormond Street Hospital for Children NHS Foundation Trust. She has a particular interest in the quality of life and the lived experience of people with bleeding disorders. Neelam Thukral, CCRC, is a clinical research coordinator at the Indiana Hemophilia & Thrombosis Center, Inc. Angela Tom, MS, BSN, is a medical science liaison at Biogen. She relies on her previous experience as a nurse practitioner in a hemophilia treatment center to inform her scientific engagement with hemophilia providers. She received her BSN and MS from the University of Arizona. Sally McAlister, BSN, has worked in hemophilia for 38 years, including serving as the University of Michigan Hemophilia Treatment Center (HTC)'s nurse coordinator, executive director for the Hemophilia Foundation of Michigan, and director of the HTC Program at the Centers for Disease Control and Prevention (CDC). She currently serves as director, US Medical at Biogen.
authors.forename: Kim
authors.initials: K
authors.lastname: Schafer
authors.forename: James
authors.initials: J
authors.lastname: Munn
authors.forename: Kate
authors.initials: K
authors.lastname: Khair
authors.forename: Neelam
authors.initials: N
authors.lastname: Thukral
authors.forename: Angela
authors.initials: A
authors.lastname: Tom
authors.forename: Sally
authors.initials: S
authors.lastname: McAlister
mesh_terms: D019540:Area Under Curve; D005169:Factor VIII / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D006207:Half-Life; D006801:Humans; D007141:Immunoglobulin Fc Fragments / Q000737:chemistry*; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics
chemical_list: D007141:Immunoglobulin Fc Fragments; D011993:Recombinant Fusion Proteins; D005169:Factor VIII