Consensus Report on Therapeutic Drug Monitoring of Mycophenolic Acid in Solid Organ Transplantation

Kuypers, Dirk; Meur, Yann Le; Cantarovich, Marcelo; Tredger, Michael; Tett, S. E.; Cattaneo, Dario; Tönshoff, Burkhard; Holt, David W.; Chapman, Jeremy; Gelder, Teun van

doi:10.2215/cjn.07111009

Cited by 280 publications

(282 citation statements)

References 119 publications

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“…Measuring free MPA or metabolites of MPA is so far not included in the consensus report (1). Concentration-controlled MPA dosing is only needed for patients who are at immunologic risk, patients with altered renal, hepatic or bowel function and patients undergoing minimization or withdrawal of therapy.…”

Section: Discussionmentioning

confidence: 99%

“…The drug is administered to kidney, heart, liver, lung, bowel, pancreas and bone marrow transplant patients. MPA is commonly used in combination with corticosteroids and calcineurin inhibitors, such as tacrolimus and cyclosporine, or in combination with the macrolide antibiotic sirolimus (1).…”

Section: Introductionmentioning

confidence: 99%

“…Therapeutic drug monitoring (TDM) of MPA may minimize the risk for rejection after transplantation. Despite insufficient evidence to provide unequivocal guidelines on the requirement for MPA monitoring in liver transplantation, the latest Consensus Report indicated six conditions where TDM of MPA is recommended (1). Monitoring the area under the curve (AUC) has been recommended, an AUC 0-12 h )30 mg/L/h and -60 mg/L/h provides optimal prophylaxis (1,5).…”

Section: Introductionmentioning

confidence: 99%

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Performance of the Roche Total Mycophenolic Acid^® assay on the Cobas Integra 400^®, Cobas 6000^® and comparison to LC-MS/MS in liver transplant patients

Decavele

Favoreel

Heyden

et al. 2011

Clinical Chemistry and Laboratory Medicine

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Background: Mycophenolic acid (MPA) is an immunosuppressant for which therapeutic drug monitoring (TDM) is performed for optimal prophylaxis and avoidance of toxicity in transplant patients. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is ideally suited for TDM of MPA. There have been several method comparisons of the Roche Total MPA assay, but none have been performed with respect to liver transplant patients. Conclusions:The Roche Total Mycophenolic Acid-assay is suitable for measuring total MPA in plasma from liver transplant patients and is a good alternative for LC-MS/MS.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Performance of the Roche Total Mycophenolic Acid^® assay on the Cobas Integra 400^®, Cobas 6000^® and comparison to LC-MS/MS in liver transplant patients

Decavele

Favoreel

Heyden

et al. 2011

Clinical Chemistry and Laboratory Medicine

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“…Its efficacy in autoimmune diseases and other glomerular diseases is increasingly appreciated (98,99). Therapeutic drug monitoring has not revealed a clear relationship between mycophenolate exposure and prevention of rejection in recipients of kidney transplants or clinical efficacy parameters in rheumatologic diseases (100). Two formulations are available, mycophenolate mofetil and enteric-coated mycophenolate sodium, with generic formulations available for both.…”

Section: Antimetabolites: Inhibition Of Dna Synthesismentioning

confidence: 99%

Immunosuppressive Medications

Wiseman¹

2016

Clinical Journal of the American Society of Nephrology

202

165

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Immunosuppressive agents are commonly used in the nephrologist's practice in the treatment of autoimmune and immune-mediated diseases and transplantation, and they are investigational in the treatment of AKI and ESRD. Drug development has been rapid over the past decades as mechanisms of the immune response have been better defined both by serendipity (the discovery of agents with immunosuppressive activity that led to greater understanding of the immune response) and through mechanistic study (the study of immune deficiencies and autoimmune diseases and the critical pathways or mutations that contribute to disease). Toxicities of early immunosuppressive agents, such as corticosteroids, azathioprine, and cyclophosphamide, stimulated intense investigation for agents with more specificity and less harmful effects. Because the mechanisms of the immune response were better delineated over the past 30 years, this specialty is now bestowed with a multitude of therapeutic options that have reduced rejection rates and improved graft survival in kidney transplantation, provided alternatives to cytotoxic therapy in immune-mediated diseases, and opened new opportunities for intervention in diseases both common (AKI) and rare (atypical hemolytic syndrome). Rather than summarizing clinical indications and clinical trials for all currently available immunosuppressive medications, the purpose of this review is to place these agents into mechanistic context together with a brief discussion of unique features of development and use that are of interest to the nephrologist.

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“…The individual variations in MPA levels may be connected to the renal and liver function, body mass and genetic polymorphisms in the enzymes and other proteins responsible for drug metabolism and transport (16,17). Since 2008, TDM of MPA is not suggested as a routine test after renal transplantation (8,18,19). The considerable individual variance in blood level observed in this study underlines the fact that MPA level depends on several factors.…”

Section: Discussionmentioning

confidence: 84%

Monitoring of mycophenolic acid and kidney function during combined immunosuppressive therapy

Oláh¹,

Asztalos²,

Ivády³

et al. 2011

Clinical Chemistry and Laboratory Medicine

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Background: Mycophenolic acid (MPA), a selective inhibitor of lymphocyte proliferation, has lately been used to improve renal function and prolong graft survival in renal transplanted patients. Still, there is no consensus considering the recommended dosing and the therapeutic range of MPA. Methods: To estimate the safe therapeutic range of MPA, its plasma level and indicators of kidney function were measured in 216 patients (138 male, 78 female, age 46"12 years) 67"46 months after transplantation. Besides MPA, patients received cyclosporine (Group A, ns122) or tacrolimus (Group B, ns77). Seventeen patients (Group C) were treated with MPA in combination with everolimus or sirolimus. Plasma MPA was measured by enzyme inhibition assay. Results: In the whole study group MPA level increased with the dose of MPA (ps0.013). MPA level was below the therapeutic range in 40% (Group A) and 45% (Group B) of patients, respectively. MPA was 1.9"1.56 mg/L in Group A, 2.4"1.69 mg/L in Group B. In Group A MPA level increased and cyclosporine decreased with the progress of renal disease. Conclusions: Increasing MPA/cyclosporine ratio at more severe stages of chronic kidney disease was tolerable for the patients and rejection could be avoided. Tubular damage detected by urinary N-acetyl-b-D-glucosaminidase did not correlate with the MPA level.

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Consensus Report on Therapeutic Drug Monitoring of Mycophenolic Acid in Solid Organ Transplantation

Cited by 280 publications

References 119 publications

Performance of the Roche Total Mycophenolic Acid^® assay on the Cobas Integra 400^®, Cobas 6000^® and comparison to LC-MS/MS in liver transplant patients

Performance of the Roche Total Mycophenolic Acid^® assay on the Cobas Integra 400^®, Cobas 6000^® and comparison to LC-MS/MS in liver transplant patients

Immunosuppressive Medications

Monitoring of mycophenolic acid and kidney function during combined immunosuppressive therapy

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Consensus Report on Therapeutic Drug Monitoring of Mycophenolic Acid in Solid Organ Transplantation

Cited by 280 publications

References 119 publications

Performance of the Roche Total Mycophenolic Acid® assay on the Cobas Integra 400®, Cobas 6000® and comparison to LC-MS/MS in liver transplant patients

Performance of the Roche Total Mycophenolic Acid® assay on the Cobas Integra 400®, Cobas 6000® and comparison to LC-MS/MS in liver transplant patients

Immunosuppressive Medications

Monitoring of mycophenolic acid and kidney function during combined immunosuppressive therapy

Contact Info

Product

Resources

About

Performance of the Roche Total Mycophenolic Acid^® assay on the Cobas Integra 400^®, Cobas 6000^® and comparison to LC-MS/MS in liver transplant patients

Performance of the Roche Total Mycophenolic Acid^® assay on the Cobas Integra 400^®, Cobas 6000^® and comparison to LC-MS/MS in liver transplant patients