Title

Once-daily tacrolimus extended release formulation: Experience at 2 years postconversion from a prograf-based regimen in stable liver transplant recipients

Document Type

Journal Article

Publication Date

6-1-2007

Journal

Transplantation

Volume

83

Issue

12

DOI

10.1097/01.tp.0000265445.09987.f1

Keywords

Extended release; Liver transplant; Tacrolimus; Two-year postconversion; XL

Abstract

Compliance with complex immunosuppressant drug therapies in transplant recipients might be improved with regimens that require less frequent dosing. A once-daily extended release (XL) formulation of tacrolimus has been developed that allows a 1:1 conversion from the twice-a-day tacrolimus (TAC) formulation and has a good exposure to trough concentration correlation. In an open-label, multicenter study, stable liver transplant recipients (n=69) were converted from twice-a-day TAC to XL once-daily in the morning, and were maintained for at least 2 years postconversion using the same therapeutic monitoring and patient care techniques employed with TAC. Two years after conversion, the incidence of biopsy-confirmed acute rejection was 5.8% (4 of 69); patient and graft survival was 98.6% (68 of 69). The safety profile of XL was consistent with that previously reported for TAC. Liver transplant recipients can be converted from twice-a-day TAC to once-daily XL and maintained for at least 2 years postconversion with neither unique efficacy nor safety concerns. © 2007 Lippincott Williams & Wilkins, Inc.

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