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Random pharmacokinetic profiles of EC-MPS in children with autoimmune disease

Guido Filler, Ajay Parkash Sharma, Deborah M Levy

    Pediatric Rheumatology Online Journal
    |January 6, 2010
    PubMed
    Abstract

    Insights

    Enteric-coated Mycophenolate Sodium (EC-MPS) shows variable pharmacokinetics in pediatric autoimmune disease. Monitoring drug concentration at six hours is crucial for assessing exposure to EC-MPS in children.

    Area of Science:

    • Pediatric Rheumatology
    • Pharmacokinetics
    • Drug Formulations

    Background:

    • Mycophenolate mofetil (MMF) is a key treatment for pediatric autoimmune diseases.
    • MMF dosing in children differs from transplant recipients.
    • Enteric-coated Mycophenolate Sodium (EC-MPS), a new formulation, lacks pharmacokinetic data in this population.

    Purpose of the Study:

    • To investigate the pharmacokinetics of EC-MPS in children with autoimmune diseases.
    • To compare EC-MPS pharmacokinetics with MMF.
    • To establish dosing and monitoring guidelines for EC-MPS in pediatric patients.

    Main Methods:

    • A pilot study involving 6 pediatric patients treated with EC-MPS.
    • Collection of 1-2 full 10-point pharmacokinetic profiles per patient over 12 hours.
    • Comparison of results with 22 pediatric patients on MMF therapy.

    Main Results:

    • Median EC-MPS dose was 724 mg/m2.
    • Area-Under-The-(Time-Concentration)-Curves (AUCs) for MPA were comparable between MMF and EC-MPS.
    • EC-MPS exhibited random pharmacokinetic profiles with variable time to maximum concentration; the 6-hour concentration correlated best with AUC.

    Conclusions:

    • EC-MPS demonstrates a distinct pharmacokinetic profile compared to MMF.
    • Complete pharmacokinetic profiling is recommended for patients on EC-MPS to ensure adequate drug exposure.
    • Targeting a 6-hour concentration of 3-4 mg/L may provide an estimate of exposure.

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