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Higher mycophenolate dose requirements in children undergoing hematopoietic cell transplant (HCT)

Pamala Jacobson1, Jaiyin Huang, Nancy Rydholm

  • 1Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455, USA. jacob117@umn.edu

Journal of Clinical Pharmacology
|February 26, 2008
PubMed

Insights

Pediatric hematopoietic cell transplant recipients require higher mycophenolate mofetil doses than previously thought. A minimum dose of 15 mg/kg intravenously every 8 hours is recommended with cyclosporine for optimal exposure.

Area of Science:

  • Pharmacology
  • Hematology
  • Transplantation

Background:

  • Dosing of mycophenolate mofetil (MMF) in pediatric hematopoietic cell transplant (HCT) recipients is not well-established.
  • Existing dosing strategies are often extrapolated from other patient populations.
  • This study addresses the need for specific pharmacokinetic data in pediatric HCT.

Purpose of the Study:

  • To evaluate the pharmacokinetics of MMF in pediatric HCT recipients.
  • To determine appropriate MMF dosing to achieve therapeutic concentrations in this population.
  • To compare MMF exposure in pediatric HCT recipients with other pediatric transplant populations.

Main Methods:

  • Pharmacokinetic analysis of MMF in 19 pediatric HCT recipients (median age 17 months) receiving MMF and cyclosporine.
  • Administration of MMF at 15 mg/kg intravenously every 8 hours to most subjects.
  • Measurement of total and unbound mycophenolic acid area under the concentration-time curve (AUC) and trough concentrations.

Main Results:

  • Median total MPA AUC(0-8) was 12.6 mcg.h/mL and unbound MPA AUC(0-8) was 0.274 mcg.h/mL.
  • Trough concentrations were poor surrogates for overall drug exposure (AUC).
  • MMF dose requirements appear higher in pediatric HCT compared to pediatric organ transplant recipients.

Conclusions:

  • Pediatric HCT recipients require a minimum MMF dose of 15 mg/kg IV every 8 hours when co-administered with cyclosporine.
  • This dose aims to achieve systemic concentrations comparable to those considered therapeutic in adult HCT patients.
  • Optimized MMF dosing is crucial for successful outcomes in pediatric HCT.

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