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

Sander Florman, Rita Alloway, Munci Kalayoglu, Jeffrey Punch, Thomas Bak, Joseph Melancon, Goran Klintmalm, Stephan Busque, Michael Charlton, John Lake, Shobha Dhadda, Kathleen Wisemandle, Mary Wirth, William Fitzsimmons, John Holman, M. Roy First

Research output: Contribution to journalArticle

42 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)1639-1642
Number of pages4
JournalTransplantation
Volume83
Issue number12
DOIs
StatePublished - Jun 1 2007

Keywords

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

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