Abstract
The immunosuppressant drugs cyclosporine, tacrolimus, sirolimus, everolimus and mycophenolic acid used to prevent transplant organ rejection require routine therapeutic drug monitoring. Because cyclosporine, tacrolimus, sirolimus and everolimus are strongly bound to erythrocytes and other cellular components of blood, therapeutic drug monitoring of these drugs must be conducted using whole blood. In contrast, mycophenolic acid is not strongly bound to cellular components of the blood. Therefore, therapeutic drug monitoring of mycophenolic acid can be conducted using serum or plasma specimens. Immunoassays are commercially available for measuring whole blood concentrations of cyclosporine, tacrolimus, sirolimus and everolimus. However, for most immunoassays, extraction of the specific immunosuppressant drug from whole blood is needed for analysis. All immunoassays show significant positive bias when results are compared to values obtained by HPLC or LC–MS/MS due to significant cross-reactivities of metabolites with immunoassays. Although mycophenolic acid requires no specimen pre-treatment prior to immunoassays, positive bias in mycophenolic acid concentrations measured by immunoassays has been reported when values are compared with LC–MS/MS assay. Therefore, chromatographic methods are considered as gold standard for therapeutic drug monitoring of immunosuppressants.
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