Safety of Conversion From Twice-Daily Tacrolimus (Prograf) to Once-Daily Prolonged-Release Tacrolimus (Advagraf) in Stable Liver Transplant Recipients

Comuzzi, C.; Lorenzin, Dario; Rossetto, Anna; Faraci, Maura; Nicolini, Daniele; Garelli, P.; Bresàdola, Vittorio; Toniutto, Pierluigi; Soardo, Giorgio; Baroni, G. Svegliati; Adani, Gian Luigi; Risaliti, Andrea; Baccarani, Umberto

doi:10.1016/j.transproceed.2010.03.106

Cited by 23 publications

(22 citation statements)

References 7 publications

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“…Although the serum levels of AST and ALT were elevated, they were still within the normal limits and returned to the initial basal levels without increasing the doses of tacrolimus later on. It was already known that the trough concentration of the once-daily formulation was lower than that of the twice-daily formulation based on 1 mg to 1 mg conversion [14, 19]. In the de novo study, a higher dose of once-daily than twice-daily formulation was suggested to keep the same trough concentration of tacrolimus [20].…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, the once-daily tacrolimus formulation may provide a more convenient regimen than the twice-daily formulation and improve adherence. In preliminary studies with a small group of solid organ transplant recipients, tacrolimus administration could be safely converted from the twice-daily to the once-daily formulation [14–17]. In this study, we evaluated the safety of graft function and looked for additional benefits of converting tacrolimus administration from the twice-daily to the once-daily formulation in a large scale of liver transplant recipients.…”

Section: Introductionmentioning

confidence: 99%

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Effects of Converting Tacrolimus Formulation from Twice-Daily to Once-Daily in Liver Transplantation Recipients

Thorat

Chou

Lee

et al. 2014

BioMed Research International

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Typically, tacrolimus is administrated twice daily. Prolonged-release tacrolimus is the once-daily formulation and may be more convenient for patients. Experience with the administration of the once-daily formulation is still limited. This study enrolled 210 liver transplant recipients who had stable liver function and converted tacrolimus from a twice-daily to once-daily formulation on a 1 mg to 1 mg basis. Among 210 patients, seven patients (3.3%) were withdrawn from the once-daily formulation due to allergy and fatigue. For the other patients, the trough concentration after converting to the once-daily formulation was lower than that of the twice-daily formulation. Liver enzymes were mildly elevated in 3 months after formulation conversion and serum creatinine and uric acid were mildly decreased. Seven patients (3.4%) had clinical suspicion of acute rejection after the formulation conversion and three of them were caused by nonadherence. 155 patients (76.4%) experienced a more convenient life with an increase of social activity. Forty-seven patients (23.2%) experienced the convenience of once-daily formulation during overseas trips. In conclusion, tacrolimus can be safely converted from the twice-daily to the once-daily formulation for most stable liver recipients. Acute rejection may occur in a minority of patients during formulation conversion and should be carefully monitored.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Effects of Converting Tacrolimus Formulation from Twice-Daily to Once-Daily in Liver Transplantation Recipients

Thorat

Chou

Lee

et al. 2014

BioMed Research International

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“…39,69,[80][81][82][83][84][85][86][87][88][89][90][91][92][93][94] The majority of the studies were observational crossover studies examining pharmacokinetic profiles and efficacy in patients before and after conversion. We did not identify randomized or blinded controlled trials.…”

Section: Conversion To Tac Qd In Stable Adult Liver Transplant Recipimentioning

confidence: 99%

“…69,[80][81][82][83][84][85][86] However, this finding was not universal across all studies and, even in studies showing an initial mean decrease in trough levels, a subset of patients had higher levels after conversion. 69,87 A detailed open-label multicenter prospective study investigated the pharmacokinetic effect of crossover using a four-period crossover design in which patients received TAC BID and TAC QD in alternating 14 day blocks. 88 Importantly, as with studies in de novo liver transplants, the AUC and trough levels were highly correlated, which supports routing clinical drug level monitoring using trough levels.…”

Section: Conversion To Tac Qd In Stable Adult Liver Transplant Recipimentioning

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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“…Tac QD possibly contributes to reduce physical and mental stress for patients who need to take several different medications. In de novo kidney, liver, and heart transplantation, phase II studies have demonstrated that patients can be converted from Tac BID to Tac QD on a one-to-one total daily-dose basis [3], and the efficacy and safety of Tac QD were maintained in long-term graft survival [4]. Randomized phase III studies have reported that Tac QD was well tolerated with similar efficacy and safety profiles to Tac BID in kidney and liver transplantation [5,6].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics for once-daily modified release formulation of tacrolimus hydrate in unrelated hematopoietic stem cell transplantation

et al. 2014

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A once-daily modified release formulation of oral tacrolimus (Tac QD) has been developed in response to the problem of nonadherence. However, there have been no data available about the efficacy of Tac QD conversion from intravenous Tac (Tac i.v.) in allogeneic hematopoietic stem cell transplantation (allo-SCT). We analyzed the pharmacokinetics (PK) of Tac QD in allo-SCT recipients. A total of 10 patients with hematological malignancies who received allo-SCT from unrelated donors were enrolled. Patients received Tac i.v. at 0.03 mg/kg a day before transplantation. Administration of Tac i.v. was converted to Tac QD at a 1:4 ratio when the patients had recovered from regimen-related gastrointestinal toxicity and could tolerate oral medication. After conversion, six out of 10 patients (60 %) showed a sustained decrease in Tac exposure and required dose adjustment. The conversion from Tac i.v. to Tac QD should be performed under close medical supervision. Area under the curve (AUC) and the trough of Tac QD showed a correlation, and the trough should be maintained above 7.5 ng/ml to provide an adequate AUC. Although four patients received bone marrow from an HLA DRB1 1 antigen-mismatched unrelated donor, no patients developed grade III-IV acute graft-versus-host disease (GVHD). The modification of Tac QD to maintain a whole-blood trough concentration above 7.5 ng/ml may be as effective as Tac BID.

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Safety of Conversion From Twice-Daily Tacrolimus (Prograf) to Once-Daily Prolonged-Release Tacrolimus (Advagraf) in Stable Liver Transplant Recipients

Cited by 23 publications

References 7 publications

Effects of Converting Tacrolimus Formulation from Twice-Daily to Once-Daily in Liver Transplantation Recipients

Effects of Converting Tacrolimus Formulation from Twice-Daily to Once-Daily in Liver Transplantation Recipients

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

Pharmacokinetics for once-daily modified release formulation of tacrolimus hydrate in unrelated hematopoietic stem cell transplantation

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