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NDT Advance Access originally published online on July 19, 2007
Nephrology Dialysis Transplantation 2007 22(12):3638-3645; doi:10.1093/ndt/gfm468
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© The Author [2007]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org


Is a standard fixed dose of mycophenolate mofetil ideal for all patients?

Wai-Ping Yau1, Anantharaman Vathsala2, Huei-Xin Lou3 and Eli Chan1

1Department of Pharmacy, Faculty of Science, National University of Singapore, 18 Science Drive 4, Singapore 117543, 2Department of Renal Medicine and 3Department of Pharmacy, Singapore General Hospital, Outram Road, Singapore 169608, Singapore

Correspondence to: Associate Prof. Eli Chan, Department of Pharmacy, Faculty of Science, National University of Singapore, 18 Science Drive 4, Singapore 117543, Republic of Singapore. Email: phaelic{at}nus.edu.sg



  Abstract

Background. A standard fixed dose of 2 g/day of mycophenolate mofetil (MMF), irrespective of total body weight (TBW), is recommended when used in combination with cyclosporine and corticosteroids in renal transplantation.

Methods. To determine the optimal MMF dose in a population with wide variation in TBW, steady-state pharmacokinetics of mycophenolic acid (MPA) was performed in 53 Asian (Chinese, Malay, Indian, Eurasian) renal transplant recipients (RTX) receiving MMF [250–1000 mg twice daily (BD)] for at least 3 months. Blood samples were collected at 0, 0.5, 1, 1.5, 2 and 6 h after the MMF dose and total MPA quantified using HPLC.

Results. Drug exposure, as evaluated by AUCss, 0–12, demonstrated a significant positive correlation with TBW-adjusted MMF dose (outliers omitted: r2 = 0.49, P < 0.0005). An AUCss, 0–12 of 45 mg h/l could be attained with an MMF dose of 12 mg/kg BD.

Conclusion. This study proposes that MMF should be dosed based on TBW rather than a fixed dose regimen in RTX.

Keywords: asian; cyclosporine; mycophenolic acid; pharmacokinetics; renal transplant; weight-adjusted dosing

Received for publication: 16. 5.07
Accepted in revised form: 19. 6.07


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