Pharmacokinetic study of once-daily formulation of tacrolimus (Advagraf) in stable Chinese kidney transplant recipients

• Published in: Hong Kong journal of nephrology 2016-10, Vol.19, p.1-6
• Main Authors: Ma, Terry King-Wing, Chow, Kai Ming, Cheng, Phyllis Mei-Shan, Kwan, Bonnie Ching-Ha, Leung, Chi Bon, Li, Philip Kam-Tao, Szeto, Cheuk Chun
• Format: Article
• Language: English
• Subjects: pharmacokinetic; renal transplant; tacrolimus
• ISSN: 1561-5413; 1876-4371
• DOI: 10.1016/j.hkjn.2016.03.002

The objective of this study is to determine whether tacrolimus trough level is appropriate for therapeutic drug monitoring (TDM) of Advagraf in stable Chinese kidney transplant recipients (KTRs). In this single-center pharmacokinetic study, stable adult Chinese KTRs on Advagraf were recruited and their blood tacrolimus levels measured at 12 time points within 24 hours. Trough level was defined as predose drug level (C0). The pharmacokinetic parameters were calculated using standardized noncompartmental methods. Drug exposure, defined as 24-hour area under the curve (AUC0–24), was calculated using the linear trapezoidal method. Whole blood tacrolimus level measurement was performed by high-performance liquid chromatography/tandem mass spectrophotometry. Fourteen patients (8 males; mean age, 47.1 ± 9.2 years; mean duration of transplant, 8.3 ± 3.6 years) completed the study. The mean C0 was 4.4 ± 1.9 ng/mL, and the mean AUC0–24 was 143.8 ± 57.0 ng h/mL. The mean maximum concentration (Cmax) was 10.2 ± 3.9 ng/mL, and the median time to Cmax was 2.0 hours (interquartile range, 1.0–3.0 hours). There was a strong correlation between C0 and AUC0–24 (r = 0.90, p