Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2003 Sep;56(3):327-30.
doi: 10.1046/j.0306-5251.2003.01882.x.

Tacrolimus dose requirement in renal transplant recipients is significantly higher when used in combination with corticosteroids

Dennis A Hesselink  1 , Hien Ngyuen, Marike Wabbijn, Peter J H Smak Gregoor, Ewout W Steyerberg, Iza C van Riemsdijk, Willem Weimar, Teun van Gelder
Affiliations
Clinical Trial

Tacrolimus dose requirement in renal transplant recipients is significantly higher when used in combination with corticosteroids

Dennis A Hesselink et al. Br J Clin Pharmacol. 2003 Sep.

Abstract

Aims: To evaluate the effect of corticosteroids on tacrolimus pharmacokinetics.

Methods: In a randomized trial, kidney transplant recipients were treated with tacrolimus and mycophenolate mofetil with either daclizumab (n = 31) or 3 months of prednisone (n = 34). Tacrolimus dose-adjusted predose concentrations (C0) at month 1-6 were compared between both groups and within the corticosteroid group before and after prednisone withdrawal.

Results: At month 1 the tacrolimus dose-adjusted C0 in the corticosteroid group was 83 +/- 8 vs 119 +/- 17 ng ml-1 mg-1 kg-1 in the daclizumab group. The tacrolimus dose-adjusted C0 within the corticosteroid group at month 1 and 2 was 42% and 29% lower compared with month 4 (P < 0.001).

Conclusions: A higher tacrolimus dose is required to reach target concentrations when used in combination with corticosteroids.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Mean tacrolimus dose-adjusted predose concentrations (C0) (ng ml−1 mg−1 kg−1) (± SEM) in all patients (a). At months 1–3 the tacrolimus dose-adjusted C0 is higher for patients treated with daclizumab (n = 31 (▴)) compared with patients treated with corticosteroids (n = 34 (□)), but the overall difference between the two groups was not significantly different (LME P = 0.06). Within the corticosteroid group, the tacrolimus dose-adjusted C0 is significantly lower before prednisone withdrawal (months 1 and 2) compared with after prednisone withdrawal (months 4–6). When patients using calcium-channel blockers were excluded (b), a lower tacrolimus dose-adjusted C0 was observed in patients treated with corticosteroids (n = 25 (□)) compared to patients treated with daclizumab (n = 22 (▴)).
See this image and copyright information in PMC

References

    1. Winkler M, Christians U. A risk-benefit assessment of tacrolimus in transplantation. Drug Saf. 1995;12:348–357. - PubMed
    1. Oellerich M, Armstrong VW, Schutz E, Shaw LM. Therapeutic drug monitoring of cyclosporine and tacrolimus. Update on Lake Louise Consensus Conference on cyclosporin and tacrolimus. Clin Biochem. 1998;31:309–316. - PubMed
    1. Krahenbuhl S, Menafoglio A, Giostra E, Gallino A. Serious interaction between mibefradil and tacrolimus. Transplantation. 1998;66:1113–1115. - PubMed
    1. Chenhsu RY, Loong CC, Chou MH, Lin MF, Yang WC. Renal allograft dysfunction associated with rifampin–tacrolimus interaction. Ann Pharmacother. 2000;34:27–31. - PubMed
    1. Moreno M, Latorre A, Manzanares C, et al. Clinical management of tacrolimus drug interactions in renal transplant patients. Transplant Proc. 1999;31:2252–2253. - PubMed

MeSH terms