Abstract:
:Once-daily tacrolimus (denoted here simply as OD) is a recently developed extended release drug formulation. The purpose of the present study was to pharmacokinetically evaluate tacrolimus exposure and determine the feasibility of its de novo use in liver transplant recipients in the perioperative period. This was an open-label, single center study. Eligible patients were 18 to 65 years of age in the perioperative period after a liver transplant. Patients were initially treated with intravenous tacrolimus and then converted to the 10× milligram-for-milligram daily dose of OD administered once daily. Twenty-four hour pharmacokinetic profiles were obtained on day 7 after the conversion. Laboratory and safety parameters were also evaluated. A total of 9 patients received OD, were successfully converted, and provided pharmacokinetic profiles. Intravenous tacrolimus and OD resulted in similar areas under the curve for 24 h (AUC0-24) of tacrolimus. OD was well tolerated with a safety profile comparable to that of intravenous tacrolimus. The AUC0-24 correlated with the minimum concentration of OD (R = 0.49). Renal and liver functions remained stable. None of the patients experienced acute rejection during the observation period. OD and intravenous tacrolimus provide equivalent drug exposure, allowing conversion of selected liver transplant recipients from intravenous tacrolimus to OD in the peri-operative period.
journal_name
Biosci Trendsjournal_title
Bioscience trendsauthors
Sugawara Y,Miyata Y,Kaneko J,Tamura S,Aoki T,Sakamoto Y,Hasegawa K,Yamashiki N,Kokudo Ndoi
10.5582/bst.2011.v5.4.156subject
Has Abstractpub_date
2011-08-01 00:00:00pages
156-8issue
4eissn
1881-7815issn
1881-7823pii
446journal_volume
5pub_type
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