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Estimating and interpreting the pharmacokinetic profiles of individual patients with hemophilia A or B using a population pharmacokinetic approach: communication from the SSC of the ISTH

2017; Elsevier BV; Volume: 15; Issue: 12 Linguagem: Inglês

10.1111/jth.13867

1538-7933

Alfonso Iorio, Victor S. Blanchette, Jan Blatný, Peter W. Collins, Kathelijn Fischer, Ellis J. Neufeld,

Platelet Disorders and Treatments

The ISTH SSC on Factor VIII/IX has previously issued guidelines for studies assessing the pharmacokinetics (PK) of factor concentrates 1,2. It suggested drawing 10 or 11 blood samples over a period of 32–48 h or 50–72 h, after infusing 25–50 IU kg−1 or 50–75 IU kg−1, respectively, for FVIII or FIX, in cohorts of 12–15 patients with a crossover design. Such PK studies are not ideal for tailoring the treatment of individual patients, mostly because of the requirement for several blood samples. Owing to broad interindividual variation, the individual disposition of FVIII and FIX cannot be predicted from morphometric characteristics and average PK parameters, but requires empirical assessment in each individual 3-6.