The safety of calcineurin inhibitors for kidney-transplant patients

Expert Opin Drug Saf. 2015 Oct;14(10):1531-46. doi: 10.1517/14740338.2015.1083974. Epub 2015 Sep 2.

Abstract

Introduction: Cyclosporine-A and tacrolimus are the cornerstones in modern immunosuppression after organ transplantation. They are potent inhibitors of calcineurin, that is, so-called calcineurin-inhibitors (CNIs). However, because these drugs have narrow therapeutic windows, they are associated with many side-effects, with some being dose related.

Areas covered: The most frequent side-effect of CNIs is nephrotoxicity, which in the long term can contribute, to allograft deterioration. Other frequent side-effects include metabolic disorders (new onset of diabetes, dyslipidemia), neurotoxicity, or promoting of de novo cancers.

Expert opinion: In kidney transplantation, many strategies have been developed to minimize nephrotoxicity while maintaining efficacy of immunosuppression: for example, the minimization of CNI in addition to either full-dose mycophenolic acid or low doses of m-TOR inhibitors, mainly everolimus (EVR). Attempts made to eliminate CNIs by replacing them with m-TOR inhibitors have been unsuccessful because of occurrence of de novo donor-specific alloantibodies in a substantial number of patients, associated with antibody-mediated rejection. Conversely, CNI-avoidance by replacing them by Belatacept is feasible with very good renal function in the long term despite a significant increase in acute cellular rejections within the first-year posttransplantation. Other side-effects of CNIs, such as neurologic disorders, diabetes, dyslipidemia, viral infections, and cancer, seem to be less frequent in low-dose or CNI-free immunosuppressive regimens. Thus, although CNIs remain the major immunosuppressive treatment, their dosage should be minimized by using them with either full-dose MPA or reduced-dose EVR.

Keywords: calcineurin inhibitors; cyclosporine; diabetes; nephrotoxicity; neurotoxicity; safety; tacrolimus.

Publication types

  • Review

MeSH terms

  • Calcineurin Inhibitors / administration & dosage
  • Calcineurin Inhibitors / adverse effects*
  • Cyclosporine / administration & dosage
  • Cyclosporine / adverse effects
  • Cyclosporine / pharmacology
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Everolimus / administration & dosage
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / adverse effects*
  • Immunosuppressive Agents / pharmacology
  • Kidney Diseases / chemically induced
  • Kidney Diseases / prevention & control
  • Kidney Diseases / surgery
  • Kidney Transplantation / methods*
  • Mycophenolic Acid / administration & dosage
  • Tacrolimus / administration & dosage
  • Tacrolimus / adverse effects
  • Tacrolimus / pharmacology

Substances

  • Calcineurin Inhibitors
  • Immunosuppressive Agents
  • Cyclosporine
  • Everolimus
  • Mycophenolic Acid
  • Tacrolimus