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Bioavailability and costs of once‐daily and twice‐daily tacrolimus formulations in de novo kidney transplantation
Author(s) -
Glander Petra,
Waiser Johannes,
Kasbohm Silke,
Friedersdorff Frank,
Peters Robert,
Rudolph Birgit,
Wu Kaiyin,
Budde Klemens,
Liefeldt Lutz
Publication year - 2018
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.13311
Subject(s) - tacrolimus , medicine , bioavailability , immunosuppression , transplantation , pharmacokinetics , kidney transplantation , urology , trough concentration , trough level , kidney transplant , pharmacology
The use of once‐daily tacrolimus in de novo kidney transplantation is increasingly common. Therefore, we were interested in bioavailability aspects of novel once‐daily tacrolimus ( LCPT , Envarsus) and once‐daily tacrolimus extended‐release formulation ( ER ‐Tac, Advagraf) compared with twice‐daily immediate‐release tacrolimus ( IR ‐Tac, Prograf). Furthermore, we calculated the costs. Kidney allograft recipients on tacrolimus‐based immunosuppression within 2 clinical trials were included in a single‐center analysis. The tacrolimus formulations were compared with respect to daily doses, doses per body weight, trough levels, and concentration‐dose (C/D) ratio over 12 months. Intrapatient variability in trough levels and C/D ratios after 3 months was calculated. For the calculation of tacrolimus costs, German list prices were used. Eighty patients (21 with LCPT , 23 with IR ‐Tac, and 36 with ER ‐Tac) were analyzed. Pharmacokinetic comparisons revealed significantly higher bioavailability of LCPT at all visits. The variability of trough levels and C/D ratios in general was high and highest in LCPT patients. Different dose requirements translated into different costs. Median treatment costs during the first year were 7.825€ ( IQR 6.195‐8.892€) for LCPT , 9.813€ ( IQR 7.630‐16.832€) for IR ‐Tac, and 9.838€ ( IQR 7.503‐ 13.541€) for ER ‐Tac (Kruskal‐Wallis test, P = .003). The 3 tacrolimus formulations exhibit different dose requirements, exposure, and costs in favor of LCPT .