Automated monitoring of C2 and C0 blood levels of mycophenolic acid and cyclosporine on the Abbott Architect c8000

Böer, Klas; Brehmer-Streck, Sybille; Deufel, Thomas; Schmidt, Dirk; Kiehntopf, Michael

doi:10.1016/j.clinbiochem.2007.06.011

Cited by 9 publications

(7 citation statements)

References 18 publications

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“…Therefore, immunoassays are less specific and have a positive bias compared with LC-MS methods. 52,53,88 Moreover, the extent of this positive bias differs depending on type of organ transplantation, time after transplantation, sampling time (ie, trough levels versus post-dose sampling), administered dose, and concomitant immunosuppressive therapy probably due to differences in the ratio of parent molecule/metabolites. 89 Clinicians should be aware of these differences between assays as target concentration ranges should differ depending on the assay used (ie, lower for LC-MS methods compared with immunoassays).…”

Section: Cni Metabolitesmentioning

confidence: 98%

“…In particular for some immunoassays, the low trough level ranges for cyclosporine (C 0 50-100 ng/mL) and tacrolimus (C 0 3-7 ng/mL) are near or even below limit of quantification. [50][51][52][53] Therefore, when CNI minimization is performed, an appropriate and sufficiently sensitive method (desired limit of quantification of approximately 20 and 1 ng/mL for cyclosporine and tacrolimus, respectively), either an immunoassay 51,54 or a liquid chromatography/mass spectrometry/mass spectrometry (LC-MS/MS) method, 54,55 should be used to facilitate proper TDM.…”

Section: Cni Minimizationmentioning

confidence: 99%

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New Insights Into the Pharmacokinetics and Pharmacodynamics of the Calcineurin Inhibitors and Mycophenolic Acid: Possible Consequences for Therapeutic Drug Monitoring in Solid Organ Transplantation

Jonge

Naesens²,

Kuypers³

2009

Therapeutic Drug Monitoring

139

108

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Although therapeutic drug monitoring (TDM) of immunosuppressive drugs has been an integral part of routine clinical practice in solid organ transplantation for many years, ongoing research in the field of immunosuppressive drug metabolism, pharmacokinetics, pharmacogenetics, pharmacodynamics, and clinical TDM keeps yielding new insights that might have future clinical implications. In this review, the authors will highlight some of these new insights for the calcineurin inhibitors (CNIs) cyclosporine and tacrolimus and the antimetabolite mycophenolic acid (MPA) and will discuss the possible consequences. For CNIs, important relevant lessons for TDM can be learned from the results of 2 recently published large CNI minimization trials. Furthermore, because acute rejection and drug-related adverse events do occur despite routine application of CNI TDM, alternative approaches to better predict the dose-concentration-response relationship in the individual patient are being explored. Monitoring of CNI concentrations in lymphocytes and other tissues, determination of CNI metabolites, and CNI pharmacogenetics and pharmacodynamics are in their infancy but have the potential to become useful additions to conventional CNI TDM. Although MPA is usually administered at a fixed dose, there is a rationale for MPA TDM, and this is substantiated by the increasing knowledge of the many nongenetic and genetic factors contributing to the interindividual and intraindividual variability in MPA pharmacokinetics. However, recent, large, randomized clinical trials investigating the clinical utility of MPA TDM have reported conflicting data. Therefore, alternative pharmacokinetic (ie, MPA free fraction and metabolites) and pharmacodynamic approaches to better predict drug efficacy and toxicity are being explored. Finally, for MPA and tacrolimus, novel formulations have become available. For MPA, the differences in pharmacokinetic behavior between the old and the novel formulation will have implications for TDM, whereas for tacrolimus, this probably will not to be the case.

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Section: Cni Metabolitesmentioning

confidence: 98%

Section: Cni Minimizationmentioning

confidence: 99%

New Insights Into the Pharmacokinetics and Pharmacodynamics of the Calcineurin Inhibitors and Mycophenolic Acid: Possible Consequences for Therapeutic Drug Monitoring in Solid Organ Transplantation

Jonge

Naesens²,

Kuypers³

2009

Therapeutic Drug Monitoring

139

108

View full text Add to dashboard Cite

show abstract

“…287,288 However, the reagents can be adapted for use on other manufacturers' analytical platforms: a family of Cobas MIRA analyzers, 263,[289][290][291][292][293][294][295][296][297][298][299] Hitachi 911, 300 Architect c8000, 301 and Dimension. 301 The measurement range of the assay stated by the manufacturer is 0.1-15 mg/L. This range is sufficient when monitoring steady-state trough concentrations.…”

Section: Emitmentioning

confidence: 99%

“…The positive bias is primarily believed to be caused by cross-reactivity with the metabolite AcMPAG, although other factors are also suspected. 263,[287][288][289][290]292,[295][296][297][298]301,302 EMIT may serve as an example of how analytical methods influence TDM. The MPA therapeutic range for trough concentration has been set at 1.0-3.5 mg/L for HPLC methods and at 1.3-4.5 mg/L for EMIT.…”

Section: Emitmentioning

confidence: 99%

Personalized Therapy for Mycophenolate: Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Bergan¹,

Brunet²,

Hesselink³

et al. 2021

Therapeutic Drug Monitoring

121

237

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When mycophenolic acid (MPA) was originally marketed for immunosuppressive therapy, fixed doses were recommended by the manufacturer. Awareness of the potential for a more personalized dosing has led to development of methods to estimate MPA area under the curve based on the measurement of drug concentrations in only a few samples. This approach is feasible in the clinical routine and has proven successful in terms of correlation with outcome. However, the search for superior correlates has continued, and numerous studies in search of biomarkers that could better predict the perfect dosage for the individual patient have been published. As it was considered timely for an updated and

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“…Several methods have been reported for the analysis of MPA and its metabolites in different biological fluids by electrophoresis [11] , [12] , [13] , [14] , immunoassay technique [15] , [16] , [17] , high performance liquid chromatography using diode array [18] , fluorescence [19] , [20] , [21] , UV [22] , [23] , [24] , [25] , [26] , [27] , [28] , [29] , and mass spectrometry detection [30] , [31] , [32] , [33] , [34] , [35] , [36] , [37] , [38] , [39] , [40] , [41] . Relatively few UPLC–MS/MS based methods are available in literature for rapid analysis of MPA in biological samples [42] , [43] .…”

Section: Introductionmentioning

confidence: 99%

Determination of mycophenolic acid in human plasma by ultra performance liquid chromatography tandem mass spectrometry

Upadhyay

Trivedi

Shah

et al. 2014

Journal of Pharmaceutical Analysis

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A simple, sensitive and high throughput ultra performance liquid chromatography tandem mass spectrometry method has been developed for the determination of mycophenolic acid in human plasma. The method involved simple protein precipitation of MPA along with its deuterated analog as an internal standard (IS) from 50 µL of human plasma. The chromatographic analysis was done on Acquity UPLC C18 (100 mm×2.1 mm, 1.7 µm) column under isocratic conditions using acetonitrile and 10 mM ammonium formate, pH 3.00 (75:25, v/v) as the mobile phase. A triple quadrupole mass spectrometer operating in the positive ionization mode was used for quantitation. In-source conversion of mycophenolic glucuronide metabolite to the parent drug was selectively controlled by suitable optimization of cone voltage, cone gas flow and desolvation temperature. The method was validated over a wide concentration range of 15–15000 ng/mL. The mean extraction recovery for the analyte and IS was >95%. Matrix effect expressed as matrix factors ranged from 0.97 to 1.02. The method was successfully applied to support a bioequivalence study of 500 mg mycophenolate mofetil tablet in 72 healthy subjects.

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Automated monitoring of C2 and C0 blood levels of mycophenolic acid and cyclosporine on the Abbott Architect c8000

Cited by 9 publications

References 18 publications

New Insights Into the Pharmacokinetics and Pharmacodynamics of the Calcineurin Inhibitors and Mycophenolic Acid: Possible Consequences for Therapeutic Drug Monitoring in Solid Organ Transplantation

New Insights Into the Pharmacokinetics and Pharmacodynamics of the Calcineurin Inhibitors and Mycophenolic Acid: Possible Consequences for Therapeutic Drug Monitoring in Solid Organ Transplantation

Personalized Therapy for Mycophenolate: Consensus Report by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology

Determination of mycophenolic acid in human plasma by ultra performance liquid chromatography tandem mass spectrometry

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