Monitoring

Monitoring of fondaparinux drug level or pharmacodynamic effect was not required during the clinical studies establishing its efficacy. Consequently, monitoring has not been required by regulatory agencies. The pharmacodynamic effect of fondaparinux can be monitored using commercial assays for anti-factor Xa activity, although calibration to a standard curve derived from fondaparinux is required. However, the clinical utility of such monitoring is presently unclear (Klaeffling et al., 2006).

Fondaparinux does not prolong the bleeding time (Boneu et al., 1995). Subtle prolongation of the prothrombin time (PT; 1 s) and activated partial thromboplas-tin time (aPTT; 4 s), as well as a mild reduction in factor VIII have been reported (Smogorzewska et al., 2006).

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