A practical, one-clinic visit protocol for pharmacokinetic profile generation with the ADVATE® myPKFiT® dosing tool in severe hemophilia A subjects.

Standard pharmacokinetic (PK) assessments are demanding for persons with hemophilia A, requiring a 72hr washout and 5-11 timed blood samples. A no-washout, single-clinic visit, sparse sampling population PK (PPK) protocol is an attractive alternative. Here, we compared PK parameters obtained with a traditional washout, 6-sampling time point PPK protocol with a no-washout, single-clinic visit, reverse 2-sampling time point PPK protocol in persons with severe hemophilia A (SHA) receiving ADVATE®. 39 inhibitor-negative males with SHA (FVIII:C