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Higher Mycophenolate Dose Requirements in Children Undergoing Hematopoietic Cell Transplant (HCT)

From the Department of Experimental and Clinical Pharmacology (Dr Jacobson, Mr Huang), College of Pharmacy (Dr Tran), Cancer Center Biostatistics and Blood and Marrow Transplantation (Mr DeFor), and Division of Pediatric Blood and Marrow Transplantation (Dr Tolar, Dr Orchard), University of Minnesota, Minneapolis, and Department of Pharmacy, University of Minnesota Medical Center, Minneapolis, Minnesota (Dr Rydholm).

Little is known about dosing of mycophenolate mofetil in pediatric hematopoietic cell transplant recipients; therefore, dosing strategies using other settings have been extended to this population. The authors studied pharmacokinetics in 19 children (median 17 months) undergoing myeloablative hematopoietic cell transplant and receiving prophylactic mycophenolate and cyclosporine. All subjects except 2 received mycophenolate 15 mg/kg intravenously every 8 hours. The median (range) total mycophenolic acid area under the concentration-time curve (AUC)_0-8 was 12.6 mcg·h/mL (4.9-49.2), and unbound mycophenolic acid AUC_0-8 was 0.274 mcg·h/mL (0.037-1.4). Total and unbound mycophenolic acid trough concentrations were 0.27 (0.03-2.9) and 0.005 (0-0.034) mcg/mL, respectively. Mycophenolic acid trough concentrations were not good surrogates for overall exposure (AUC_0-8), r² 0.55. Mycophenolate dose requirements are higher in pediatric hematopoietic cell transplant recipients relative to pediatric organ transplant recipients. Children undergoing hematopoietic cell transplant should receive a mycophenolate mofetil dose of at least 15 mg/kg intravenously every 8 hours when used in combination with cyclosporine to achieve systemic concentrations near those proposed to be therapeutic in the adult hematopoietic cell transplant population.

Key Words: Mycophenolate mofetil • mycophenolic acid • hematopoietic cell transplantation • pharmacokinetics • pediatrics

Address for correspondence: Pamala Jacobson, PharmD, Department of Experimental and Clinical Pharmacology, Weaver Densford Hall 7-151, 308 Harvard St SE, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455; e-mail: jacob117{at}umn.edu.