International Journal of Clinical Pharmacy

, Volume 40, Issue 6, pp 1548–1558 | Cite as

Tolerability of mycophenolate sodium in renal transplant recipients

  • Liliane L. Hiramoto
  • Helio Tedesco-SilvaEmail author
  • Jose O. Medina-Pestana
  • Claudia R. Felipe
Research Article


Background Kidney transplant recipients (KTR) receive fixed daily doses of mycophenolate sodium as part of the immunosuppressive regimen. Dose reductions occur primarily due to adverse events and may be associated with an increased risk of acute rejection and graft loss. Objectives To evaluate the tolerability of mycophenolate in kidney transplant recipients receiving tacrolimus and prednisone. Setting The study was performed at Hospital do Rim, Federal University of São Paulo in Brazil. Method This was a retrospective cohort study including 506 patients. Tolerability of mycophenolate sodium was classified into the following groups: Temporary reduction (TR), definitive reduction (DR), temporary interruption (TI), permanent discontinuation (PD) and without modification (WM). Main outcome measure The cause of mycophenolate dose change and its influence on rejection-free survival during the first 3 years after transplantation. Results The cumulative incidence of dose change was 51.2% (11%TR, 44%DR, 24%TI, and 21%PD). Gastrointestinal (45.3%), infection (31.9%) and hematological (14.9%) systems accounted for most of the dose changes. The adverse events with higher incidence were diarrhea, cytomegalovirus (CMV) infection and leukopenia. Changes in dose of mycophenole were associated with reduced acute rejection-free survival compared with patients WM group (71.4%TR, 58.9%DR, 56.7%TI, 53.7%PD vs. 74.2%WM, p = 0.020). Only patients with PD showed inferior patient (59.3% vs. 94.4%, p = 0.001) and death-censored graft (83.3% vs. 92.5%, p = 0.074) survivals compared to patients WM. Conclusion In this cohort, changes in the dose of mycophenolate were associated with increased risk of acute rejection and permanent discontinuation was associated with inferior patient and graft survival.


Adverse drug reaction Graft survival Immunosuppression Kidney Transplant Mycophenolate sodium Tolerability 



Area under the curve of mycophenolic acid


Biopsy-proven acute rejection




Common terminology criteria for adverse events


Delayed graft function


Deoxyribonucleic acid


Definitive reduction


Inosine monophosphate dehydrogenase


Mycophenolate mofetil


Mycophenolate acid


Mycophenolate sodium


Permanent discontinuation




Rabbit anti-thymocyte globulin


Ribonucleic acid




Temporary interruption


Temporary reduction


Without modification



Liliane Hiramoto received a research grant from “Conselho Nacional de Desenvolvimento Científico e Tecnológico” (CNPq).


This study was supported by grants from CNPq.

Conflicts of interest

The authors declare that they have no conflict of interest.


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Copyright information

© Springer Nature Switzerland AG 2018

Authors and Affiliations

  1. 1.Nephrology Division, Hospital do RimFederal University of São PauloSão PauloBrazil

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