Publication details
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
| Authors | |
|---|---|
| Year of publication | 2017 |
| Type | Article in Periodical |
| Magazine / Source | Journal of Thrombosis and Haemostasis |
| MU Faculty or unit | |
| Citation | |
| Web | http://dx.doi.org/10.1111/jth.13867 |
| Doi | http://dx.doi.org/10.1111/jth.13867 |
| Field | Oncology and hematology |
| Keywords | hemophilia A; hemophilia B |
| Description | 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]. Previous guidance of this ISTH SSC described the PK methodology for the prediction of individual trough levels of FVIII [7]. The present communication, building on recent advances in the population pharmacokinetics (PopPK) of FVIII and FIX [8], adds to the former documents. |