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Diagnostic & Therapeutic Corner
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Therapeutic Monitoring of Mycophenolate Mofetil

Hyunyoung Jeong and Bruce Kaplan
CJASN January 2007, 2 (1) 184-191; DOI: https://doi.org/10.2215/CJN.02860806
Hyunyoung Jeong
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Bruce Kaplan
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    Figure 1.

    Pharmacokinetic behavior of mycophenolate mofetil (MMF) after oral administration (see text for details). MMF is converted to mycophenolic acid (MPA) presystemically, and then is subsequently metabolized to its glucuronide (Glu) conjugates, MPAG and AcMPAG, by different isoforms of UDP glucuronidyl transferses (UGT) in the liver. Pathways of enterohepatic circulation of MPA via the glucuronide conjugate metabolites are shown.

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    Table 1.

    Correlation between MMF pharmacokinetics and clinical outcomes in renal transplantationa

    StudyNo. of PatientsFollow-Up TimeCalcineurin InhibitorsTDMMPA ParametersAssay MethodClinical Outcomes
    Borrows et al. (55)1211 yrTacrolimusFixed dosageC0EMIT>1.60 mg/L is associated with low rejection rates; >2.75 mg/L is associated with hematologic toxicity and diarrhea
    Cattaneo et al. (48)469 moCsAFixed dosageAUC0-12 h, C0HPLCAUC >40 mg·h/L or C0 >1.5 mg/L is associated with better renal functions; there was a negative correlation between free MPA levels with hematocrit levels
    Hale et al. (36)1566 moCsADosage adjustment by Bayesian estimationAUC0-12 hHPLCAUC of 15 and 25 mg·h/L showed 50 and 75% maximal achievable efficacy, respectively
    Kiberd et al. (50)943 moCsAFixed dosageAUC0-12 h, C0HPLCAUC of 22 mg·h/L was a threshold for prediction of acute rejection episodes
    Kuypers et al. (20)221 yrTacrolimusFixed dosageC0HPLCC0 of MPA (total or free) and its metabolites did not correlate with clinical efficacy or toxicity
    Mourad et al. (46)51—bTacrolimusFixed dosageAUC0-12 h, C0EMITAUC of 38 mg·h/L was a threshold for toxicity (sensitivity 83%; specificity 60%)
    Oellerich et al. (35)—b6 moCsAFixed dosageAUC0-12 h, C0HPLCAUC of approximately 30 to 60 mg·h/L seems to be a reasonable target for early posttransplantation period
    Pawinski et al. (33)333 moCsA or tacrolimusFixed dosageAUC0-12 h, C0HPLCAUC of 27.5 mg·h/L and C0 of 1.1 mg/L were threshold values for prediction of acute rejection episodes
    Pillans et al. (39)271 moCsAFixed dosageAUC0-12 h, C0HPLCAUC <30 mg·h/L was associated with increased incidence of rejection; no association was found between the incidence of acute rejection and C0
    van Gelder et al. (44)1546 moCsADosage adjustment by Bayesian estimationAUC0-12 h, C0—bIncidence of acute rejection in low, intermediate, and high MPA concentration groups (16, 32, and 60 mg·h/L, respectively) were 28, 15, and 12%, respectively
    Weber et al. (34)546 moCsAFixed dosageAUC0-12 h, C0HPLCAUC of 33.8 mg·h/L differentiates acute rejection (sensitivity 75%; specificity 64%)
    • ↵a AUC, area under the curve; C0, predose concentration; CsA, cyclosporine; EMIT, enzyme-multiplied immunoassay technique; MMF, mycophenolate mofetil; MPA, mycophenolic acids; TDM, therapeutic drug monitoring.

    • ↵b Not reported.

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    Table 2.

    Current recommendation on TDM of MMF in transplantation (45)a

    Initial dosingCsA-based regimen: start MMF at 1.5 g twice daily, and then adjust dosage on the basis of TDM
    Tacrolimus-based regimen: start MMF at 1 g twice daily
    Frequency of monitoring and dose adjustmentDays 3 and 7 and once during days 10 to 14 after transplantation
        Week 3 or 4 (optional)
        Occasions of substantial changes in immunosuppressant regimen
        Occasions that require evaluation of clinical events, such as drug-related toxicity or rejection
    Assay considerationsEither HPLC or EMIT is acceptable for monitoring
    MPA target concentrations using EMIT are higher (as a result of cross-reactivity with AcMPAG)
    Target concentrations (HPLC)MPA AUC
        30 to 60 mg·h/L in the first 30 d after transplantation
    MPA C0
        CsA-based regimen: ≥1.3 mg/L
        tacrolimus-based regimen: ≥1.9 mg/L
    Special populations
        calcineurin inhibitor-sparing regimen
        a higher end of MPA target concentrations range is required
        altered protein binding: free drug MPA concentration can be higherb
        renal impairment
        high bilirubin
    Dosage adjustmentcEmbedded Image
    Embedded Image
    • ↵a Data are summary of reference (45). AcMPAG, MPA-acyl-glucuronide.

    • ↵b Because of extensive protein binding of MPA, free drug MPA concentration can be higher, although the total MPA concentration is within the target range. Therefore, under circumstances of altered protein binding, total MPA levels are difficult to assess.

    • ↵c This recommendation is under assumption of dosage linearity in MPA pharmacokinetics, which may not exist in all cases.

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Clinical Journal of the American Society of Nephrology
Vol. 2, Issue 1
January 2007
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Therapeutic Monitoring of Mycophenolate Mofetil
Hyunyoung Jeong, Bruce Kaplan
CJASN Jan 2007, 2 (1) 184-191; DOI: 10.2215/CJN.02860806

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Therapeutic Monitoring of Mycophenolate Mofetil
Hyunyoung Jeong, Bruce Kaplan
CJASN Jan 2007, 2 (1) 184-191; DOI: 10.2215/CJN.02860806
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