Comparison of generic tacrolimus and Prograf drug levels in a pediatric kidney transplant program: Brief communication

Authors

  • Husam A. Abdulnour,

    1. Division of Pediatric Nephrology, Shands Children’s Hospital and University of Florida College of Medicine, Gainesville, FL, USA
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  • Carlos E. Araya,

    1. Division of Pediatric Nephrology, Shands Children’s Hospital and University of Florida College of Medicine, Gainesville, FL, USA
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  • Vikas R. Dharnidharka

    1. Division of Pediatric Nephrology, Shands Children’s Hospital and University of Florida College of Medicine, Gainesville, FL, USA
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Vikas Dharnidharka, MD, MPH, Division of Pediatric Nephrology, Shands Children’s Hospital and University of Florida College of Medicine, PO Box 100296, Room HD-214, 1600 SW Archer Road, Gainesville, FL 32610-0296, USA
Tel.: 352 273 9180
Fax: 352 392 7107
E-mail: vikasmd@peds.ufl.edu

Abstract

Abdulnour HA, Araya CE, Dharnidharka VR. Comparison of generic tacrolimus and Prograf drug levels in a pediatric kidney transplant program: Brief communication.
Pediatr Transplantation 2010: 14:1007–1011. © 2010 John Wiley & Sons A/S.

Abstract:  A generic version of tacrolimus was approved for use in the USA in August 2009. These narrow therapeutic index generics are tested for bioequivalence only in adults. No data are available on generic tacrolimus levels in children with allografts. Four patients with stable renal allografts in our pediatric program were inadvertently switched to generic tacrolimus. We retrospectively analyzed pre- and post-switch trough tacrolimus and serum creatinine levels. Twelve-h trough tacrolimus levels (mean ± s.e.) were (i) patient 1 (12-yr-old girl): 7.0 ± 0.69 and 9.7 ± 3.5 (p = NS); (ii) patient 2 (eight-yr-old boy): 4.7 ± 0.68 and 3.4 ± 0.84 (p = 0.04); (iii) patient 3 (22-yr-old woman): 6.8 ± 0.17 and 6.6 ± 0.4 (p = NS); (iv) patient 4 (20-yr-old woman): 5.4 ± 0.25 and 4.9 ± 1.4 (p = NS). Creatinine levels were similar pre- and post-switch (eGFR > 75 mL/min/1.73 m2) in the first three. Patient 4 experienced a biopsy proven acute rejection immediately after switching. Mean creatinine rose from 1.15 ± 0.05 to 2.168 ± 0.07 after switch (p < 0.001). Given our mixed picture with the early data, we suggest careful monitoring of pediatric patients who get switched to generic tacrolimus.

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