New formulations of tacrolimus and prevention of acute and chronic rejections in adult kidney-transplant recipients

Expert Opin Drug Saf. 2017 Jul;16(7):845-855. doi: 10.1080/14740338.2017.1328051. Epub 2017 May 31.

Abstract

​Introduction: As tolerance is not yet achievable, the kidney-transplanted-patients have to take on a daily-basis immunosuppressive drugs in order to avoid acute rejection-AR-. The cornerstone of immunosuppression relies on tacrolimus-therapy which is potentially nephrotoxic. Areas Covered: We identified from the studies published in the recent years those who were reporting on AR in de novo kidney-transplant recipients under tacrolimus-based therapy, as well as those who reported on the attempt to minimize tacrolimus-therapy.

Results: There are many formulations of tacrolimus: immediate-release (Prograf®), slow-release (Advagraf®), or extended-release (Envarsus®). All demonstrate a very good efficacy in preventing AR episodes. Studies in which tacrolimus was minimized or even weaned-off have shown that it was unsafe, i.e. in resulting in AR episode and/or de novo donor-specific alloantibodies. Recent data show that Tacrobell®, a generic of tacrolimus, was as efficient as Prograf® in the short- and long-term. Expert-opinion: Tacrolimus-based immunosuppression is very effective in preventing rejection in kidney-transplant recipients. It might be associated with nephrotoxicity, that can be reduced by avoiding tacrolimus trough levels too high in the long-term. Conversely, tacrolimus ultraminimization should not be attempted.

Keywords: Tacrolimus; acute rejection; donor-specific alloantibody; graft function; minimization.

Publication types

  • Review

MeSH terms

  • Acute Disease
  • Adult
  • Animals
  • Chronic Disease
  • Delayed-Action Preparations
  • Graft Rejection / prevention & control*
  • Humans
  • Immunosuppressive Agents / administration & dosage*
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / pharmacokinetics
  • Kidney Diseases / chemically induced
  • Kidney Diseases / prevention & control
  • Kidney Transplantation / methods
  • Tacrolimus / administration & dosage*
  • Tacrolimus / adverse effects
  • Tacrolimus / pharmacokinetics
  • Transplant Recipients

Substances

  • Delayed-Action Preparations
  • Immunosuppressive Agents
  • Tacrolimus