Clinical Pharmacokinetics of Tacrolimus in Iranian Liver Transplant Recipients

Authors

  • Ali Jafarian Associate Professor of Surgery, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
  • Hossein Khalili Professor of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Mohsen Nasiri-Toosi Associate Professor of Gastroenterology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.
  • Shirinsadat Badri Assistant Professor of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences, Isfahan, Iran.
  • Sima Sadrai Associate Professor of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
  • Simin Dashti-Khavidaki 1- Associate Professor of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran. 2- Nephrology Research Center, Tehran University of Medical Sciences, Tehran, Iran.
  • Zahra Nasiri-Toosi Pharmacist, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
Abstract:

Tacrolimus, a cornerstone of immunosuppressive therapy in solid organ transplantation, has a narrow therapeutic range with considerable inter-individual and intra-individual pharmacokinetic variability. To date, there is no information on the pharmacokinetics of tacrolimus in Iranian liver transplant recipients. This study was designed to determine pharmacokinetic properties of orally administered tacrolimus in Iranian adult liver transplant recipients. Tacrolimus doses and steady state whole blood trough concentrations as well as patient demographic and clinical data were obtained retrospectively using the 30 included patients’ medical records. Pharmacokinetic parameters were estimated by using a nonlinear mixed effect model program (Monolix version 3.1). Absorption rate constant was fixed at two hours-1. Drug apparent clearance (CL/F), apparent volume of distribution (Vd/F), and elimination half life (t½β) were calculated. The administered dose of tacrolimus to the patients ranged from 0.02 to 0.14 mg/Kg/day. Tacrolimus blood trough concentrations varied widely within the range of 1.8 to 30 ng/mL. The mean values of CL/F, Vd/F, and t½β were found to be 9.3 ± 0.96 L/h, 101 ± 29 L, and 7.5 hours, respectively. The pharmacokinetics of tacrolimus was highly variable among our patients. CL/F, Vd/F, and t½β of tacrolimus in this study were comparable to reported values from Italian heart transplant patients but somewhat different from reported ones from other solid organ transplant populations.

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Journal title

volume 13  issue 1

pages  279- 282

publication date 2014-01-01

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