1. Limited sampling strategies for individualized BAX 855 prophylaxis in severe hemophilia A
- Author
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Laura H. Bukkems, Tine M.H.J. Goedhart, C. Michel Zwaan, Marjon H. Cnossen, Ron A.A. Mathôt, Pharmacy, Other Research, AII - Infectious diseases, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, and Pediatrics
- Subjects
factor VIII ,limited sampling strategy ,hemophilia A ,Hematology ,General Medicine ,extended half-life ,pharmacokinetics - Abstract
OBJECTIVE: Limited sampling strategies (LSS) lower the burden of pharmacokinetic (PK)-guided dosing, but an extensive evaluation of LSS for BAX 855 (Adynovi) is currently lacking. This study aimed to develop a LSS for BAX 855 and combine this with a LSS of a standard half-life (SHL) factor VIII (FVIII) concentrate in a clinical setting. METHODS: Individual PK parameters of BAX 855 were estimated for 10 000 virtual patients with severe hemophilia A using Monte Carlo simulations. Several LSS consisting of 2-6 samples were examined based on patient burden, bias and accuracy of clearance, elimination half-life, volume of distribution and trough levels at 72 h (C72). Analyses were performed separately for adults and children
- Published
- 2023