Once-daily tacrolimus in living donor liver transplant recipients

Sugawara, Yasuhiko; Miyata, Yuhei; Kaneko, Junichi; Tamura, Sumihito; Aoki, Taku; Sakamoto, Yoshihiro; Hasegawa, Kiyoshi; Yamashiki, Noriyo; Kokudo, Norihiro

doi:10.5582/bst.2011.v5.4.156

BST

2011

DOI: 10.5582/bst.2011.v5.4.156

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Once-daily tacrolimus in living donor liver transplant recipients

Yasuhiko Sugawara

Yuhei Miyata

Junichi Kaneko

et al.

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Cited by 3 publications

(1 citation statement)

References 11 publications

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“…[37][38][39][40][41] The effect on long-term adherence of using TAC QD in the immediate postoperative period has not been systematically studied. Several studies examined the effects of TAC QD on metabolic parameters, including glucose metabolism and these were not demonstrably improved compared to patients receiving TAC BID.…”

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confidence: 99%

Prevention of organ rejection in renal and liver transplantation with extended release tacrolimus

Reschen¹,

O’Callaghan²

2014

TRRM

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Tacrolimus is the key immunosuppressant used to prevent allograft rejection in kidney and liver transplant recipients. Despite the efficacy of tacrolimus and adjunctive immunosuppressants, a substantial number of patients experience episodes of acute rejection and late graft loss. Nonadherence is an etiological factor in both acute rejection and graft loss. In 2007, a prolonged release version of tacrolimus became available that allows once daily administration, thus halving the pill burden compared to the standard twice-daily tacrolimus. An increasing number of studies in de novo transplantation and in treatment conversion have evaluated the pharmacokinetic profile, efficacy, and safety of prolonged-release tacrolimus. We have reviewed the literature on the use of prolonged-release tacrolimus and hope that this will be of value in the design of protocols for transplant immunosuppression.

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confidence: 99%

Prevention of organ rejection in renal and liver transplantation with extended release tacrolimus

Reschen¹,

O’Callaghan²

2014

TRRM

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Clinical Pharmacokinetics of Once-Daily Tacrolimus in Solid-Organ Transplant Patients

Staatz

Tett

2015

Clin Pharmacokinet

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Tacrolimus is a pivotal immunosuppressant agent used in solid-organ transplantation. It was originally formulated for oral administration as Prograf(®), a twice-daily immediate-release capsule. In an attempt to improve patient adherence, retain manufacturer market share and/or reduce health care costs, newer once-daily prolonged-release formulations of tacrolimus (Advagraf(®) and Envarsus(®) XR) and various generic versions of Prograf(®) are becoming available. Tacrolimus has a narrow therapeutic index. Small variations in drug exposure due to formulation differences can have a significant impact on patient outcomes. The aim of this review is to critically analyse the published data on the clinical pharmacokinetics of once-daily tacrolimus in solid-organ transplant patients. Forty-three traditional (non-compartmental) and five population pharmacokinetic studies were identified and evaluated. On the basis of the stricter criteria for narrow-therapeutic-index drugs, Prograf(®), Advagraf(®) and Envarsus(®) XR are not bioequivalent [in terms of the area under the concentration-time curve from 0 to 24 h (AUC0-24) or the minimum concentration (C min)]. Patients may require a daily dosage increase if converted from Prograf(®) to Advagraf(®), while a daily dosage reduction appears necessary for conversion from Prograf(®) to Envarsus(®) XR. Prograf(®) itself, or generic immediate-release tacrolimus, can be administered in a once-daily regimen with a lower than double daily dose being reported to give 24-h exposure equivalent to that of a twice-daily regimen. Intense clinical and concentration monitoring is prudent in the first few months after any conversion to once-daily tacrolimus dosing; however, there is no guarantee that therapeutic drug monitoring strategies applicable to one formulation (or twice-daily dosing) will be equally applicable to another. The correlation between the tacrolimus AUC0-24 and C min is variable and not strong for all three formulations, indicating that trough measurements may not always give a good indication of overall drug exposure. Further investigation is required into whether the prolonged-release formulations have reduced within-subject pharmacokinetic variability, which would be a distinct advantage. Whether the effects of factors that influence tacrolimus absorption and pre-systemic metabolism (patient genotype status; gastrointestinal disease and disorders) and drug interactions differ across the formulations needs to be further elucidated. Most pharmacokinetic comparison studies to date have involved relatively stable patients, and many have been sponsored by the pharmaceutical companies manufacturing the new formulations. Larger randomized, controlled trials are needed in different transplant populations to determine whether there are differences in efficacy and toxicity across the formulations and whether formulation conversion is worthwhile in the longer term. While it has been suggested that once-daily administration of tacrolimus may improve patient compliance, further studies a...

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

King-Wing

Chow

Cheng

et al. 2016

Hong Kong Journal of Nephrology

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Once-daily tacrolimus in living donor liver transplant recipients

Cited by 3 publications

References 11 publications

Prevention of organ rejection in renal and liver transplantation with extended release tacrolimus

Prevention of organ rejection in renal and liver transplantation with extended release tacrolimus

Clinical Pharmacokinetics of Once-Daily Tacrolimus in Solid-Organ Transplant Patients

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

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