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Highly Variable Mycophenolate Mofetil Bioavailability Following Nonmyeloablative Hematopoietic Cell Transplantation

From the Department of Experimental and Clinical Pharmacology (Dr Jacobson, Dr Green, Ms Ebeling); the Department of Pharmacy (Dr Rogosheske); the Division of Hematology, Oncology, Transplantation (Dr Brunstein, Mr DeFor, Dr McGlave, Dr Weisdorf,); and the Division of Biostatistics (Mr DeFor), University of Minnesota, Minneapolis.

This study determined the oral bioavailability of mycophenolic acid, the active metabolite of mycophenolate mofetil, in patients undergoing nonmyeloablative hematopoietic cell transplantation. Eighteen adults receiving a preparative regimen containing fludarabine, cyclophosphamide, and total body irradiation were studied. Immune suppression consisted of cyclosporine and mycophenolate 1 g twice daily. Pharmacokinetic variability was high after intravenous and oral dosing. Intravenous dosing resulted in a median area under the curve (AUC) of 28.3 µg•h/mL (range, 9.96-70.4) and an oral AUC of 16.7 µg•h/mL (range, 9.38-35.3). C_max after intravenous and oral dosing was 12.18 and 5.29 µg/mL, respectively. The median oral bioavailability was 72.3% (20.5%-172%), with 8-fold variability. Five patients (28%) had an oral bioavailability 50%. At time of oral pharmacokinetics, 15 patients (83%) had an AUC_0-12 <30 µg•h/mL. The initial oral dose should be at least 25% greater than the intravenous dose with follow-up assessment of plasma concentrations.

Key Words: Bioavailability • mycophenolate mofetil • mycophenolic acid • hematopoietic cell transplantation • pharmacokinetics

Address for reprints: Pamala Jacobson, PharmD, Department of Experimental and Clinical Pharmacology, Weaver Densford Hall 7-189, 308 Harvard Street SE, College of Pharmacy, University of Minnesota, Minneapolis, MN 55455.

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				P. Jacobson, J. Huang, N. Rydholm, M. Tran, T. DeFor, J. Tolar, and P. J. Orchard Higher Mycophenolate Dose Requirements in Children Undergoing Hematopoietic Cell Transplant (HCT) J. Clin. Pharmacol., April 1, 2008; 48(4): 485 - 494. [Abstract] [Full Text] [PDF]

				D. Weisdorf GVHD The Nuts and Bolts Hematology, January 1, 2007; 2007(1): 62 - 67. [Abstract] [Full Text] [PDF]