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It was hypothesized that patients experiencing at least one tacrolimus formulation switch may require more frequent therapeutic drug monitoring, subsequent dose adjustments, and a potential for untoward clinical outcomes than patients who remain on a single formulation.
Eligible patients were adult kidney transplant recipients with stable renal function at month 3 post-transplant and no evidence of acute rejection, receiving an oral, tacrolimus-based regimen. Patients were categorized into two groups (fixed or variable formulation) using the US National Drug Code (NDC) on the basis of tacrolimus formulation usage over the 12-month period.
A total of 305 patients were enrolled from four US transplant centers; 44 (14.4%) received multiple formulations and 261 (85.6%) received a single formulation. Mean number of tacrolimus dose adjustments and mean cumulative milligram dose change were not statistically different between the two groups. Mean trough-to-dose ratio, frequency of trough level measurements, and mean number of excursions above 120% or below 80% of the patient’s mean trough concentration were significantly higher in the variable compared to the fixed formulation group.
A variable tacrolimus formulation regimen was associated with a higher frequency of trough level measurements and a greater number of excursions in trough levels compared with continuing on a fixed formulation regimen of tacrolimus in this retrospective chart review study.
Astellas Pharma Global Development, Inc.
Plain language summary available for this article.
Peters DH, Fitton A, Plosker GL, Faulds D. Tacrolimus. A review of its pharmacology, and therapeutic potential in hepatic and renal transplantation. Drugs. 1933;46(4):746–94. CrossRef
Rodrigo E, San D, Ruiz J, et al. High intra-patient variability in tacrolimus trough blood levels increases the risk of death-censored graft loss after kidney transplantation (abstract). Am J Transplant. 2015;15(Suppl 3). https://atcmeetingabstracts.com/abstract/high-intra-patient-variability-in-tacrolimus-trough-blood-levels-increases-the-risk-of-death-censored-graft-loss-after-kidney-transplantation/.
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- The Association of Tacrolimus Formulation Switching with Trough Concentration Variability: A Retrospective Cohort Study of Tacrolimus Use Post-Kidney Transplantation Based on National Drug Code (NDC) Numbers
Jason J. Schwartz
Ashley P. Butler
David P. Facklam
James R. Spalding
Maria E. Vassilakis
Gary D. Thal
William D. Irish
- Springer Healthcare
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