Anthony W Butch PhD


1. Introduction

2. Rationale for Immunosuppressive Drug Monitoring

3. Calcineurin Inhibitors

4. Mammalian Target of Rapamycin Inhibitors

5. Mycophenolic Acid

6. Conclusion

To optimize therapeutic effectiveness and minimize unwanted adverse effects, reliable and precise methods are required for monitoring blood concentrations of immunosuppressive drugs. Therapeutic monitoring of cyclosporine, tacrolimus, and sirolimus is currently considered an integral part of organ transplant programs, and compelling arguments have been made for monitoring mycophenolic acid. Although high-performance liquid chromatography (HPLC) is considered the reference method for monitoring immunosuppressive drugs, most laboratories currently measure these drugs by immunoassay. Immunoassays have gained widespread use because they can be automated, have low start-up costs, and do not require specialized testing personnel. Unfortunately, immunoassays exhibit significant metabolite cross-reactivity that differs among immunoassays and is dependent on the transplanted organ as well as time post-transplant. The advantage of HPLC methods is that they are highly specific and can separate drug metabolites from parent compound. However, HPLC methods can require extensive sample cleanup, have long analytical run times, and require specialized training. Some of these drawbacks can be partially overcome by using HPLC with mass spectrometry (MS) detection systems, although the instrumentation is currently expensive. In view of the high cost of immunoassay reagents, HPLC-MS systems are becoming more cost effective, especially when considering that they can simultaneously measure multiple immunosuppressive drugs in a single whole blood specimen.

Key Words: Therapeutic drug monitoring; immunosuppressive drugs; cyclosporine; tacrolimus; sirolimus; mycophenolic acid.


From: Handbook of Drug Monitoring Methods Edited by: A. Dasgupta © Humana Press Inc., Totowa, NJ

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