Immunsuppressiva LC-MS

Intended Use
This Immunosuppressants kit is intended for the determination of four (4) immunosuppressant medications in whole blood, conducted by laboratory professionals on LC-MS/MS.

Summary
Patients who receive a solid organ transplantation (SOT) or a stem cell transplantation (SCT) require immunosuppressant drugs to suppress the patients’ immune response to the transplant and prevent rejection of the transplant. The goal with immunosuppression is to induce donor specific tolerance for the transplant with minimal impairing of the patients’ defenses and without increasing the susceptibility to infections. The most common immunosuppressants prescribed are the calcineurine inhibitors cyclosporin and tacrolimus, and the mTOR inhibitors sirolimus and everolimus. These immunosuppressants are used for the prophylaxis and treatment of graft rejection following SOT (kidney, lung, hart, and liver) and SCT.

With cyclosporine, tacrolimus, sirolimus, and everolimus, clinical variability due to inter- and intra- patient pharmacokinetic variability is seen. This pharmacokinetic variability, in combination with an excellent correlation between blood concentrations and efficacy/toxicity of the treatment and the narrow therapeutic range of the immunosuppressive drugs, makes monitoring of blood concentrations a crucial part of the treatment. The therapeutic range for each immunosuppressant drug depends on post-transplant time, concomitant immunosuppressive medication, and immunological risk.

Therapeutic Drug Monitoring (TDM) to optimize immunosuppressive treatment and minimizing drug-related toxicity is therefore standard care in the clinical setting as well as in the outpatient setting, and TDM is advised in the Summary of Product Characteristics (SPC) of cyclosporine, tacrolimus, sirolimus, and everolimus. Furthermore, a number of consensus documents on TDM of immunosuppressive drugs have been written to assist pharmacists and clinicians to individualize the treatment.

Besides standard monitoring of drug concentrations, extra monitoring is recommended to ensure that an appropriate systemic drug exposure is maintained in case of clinical treatment failure (the occurrence of an acute rejection episode), dose adjustments or changes in the immunosuppressive regimen, a switch in (generic) formulation of the immunosuppressive drug, suspected problems with the absorption of the drug, adverse events, drug-drug interactions, relevant comorbidities, and if nonadherence is suspected.

The Diagnotix kit for measuring immunosuppressive drugs includes cyclosporine, tacrolimus, sirolimus, and everolimus. For all these drugs, reference concentrations are based on literature and an overview of target concentrations can be found in several articles as well in the SPC of cyclosporine, tacrolimus, sirolimus, and everolimus.

In conclusion, immunosuppressive drugs fulfill the prerequisites for TDM, having a narrow therapeutic window, a high intra- and inter-individual pharmacokinetic variability, and an established exposure-response relationship. TDM of immunosuppressive drugs is recommended for optimal use of these drugs in clinical practice as stated in the SPC of these drugs as well as in several international guidelines and consensus documents.

Manufactured by Diagnotix; Distributed by Tecan, IBL International GmbH.

For concrete data please consult the Instruction for Use in the download box on the top right side.

Für konkrete Daten konsultieren Sie bitte die Arbeitsanweisung in der Download Box oben auf der rechten Seite.