Therapeutic Drug Monitoring in De Novo Kidney Transplant Receiving the Modified-Release Once-Daily Tacrolimus

Jelassi, M.; Lefeuvre, Sandrine; Karras, A.; Moulonguet, L; Billaud, Éliane

doi:10.1016/j.transproceed.2011.01.043

Cited by 20 publications

(13 citation statements)

References 9 publications

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“…Despite the finding that once-daily tacrolimus provided more stable drug blood concentrations than twice-daily tacrolimus,13 it was found to be necessary to use higher doses of once-daily tacrolimus to reach targeted trough levels after conversion from twice-daily tacrolimus, which concurs with previous reports 14,15,16,17. As shown in the results, administered doses of once-daily tacrolimus were higher than those of twice-daily tacrolimus after conversion, and the mean blood trough levels of once-daily tacrolimus were lower than those of twice-daily tacrolimus, especially at post-transplant 4 and 6 months.…”

Section: Discussionsupporting

confidence: 77%

Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation

Huh

Lee

et al. 2014

Yonsei Med J

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PurposeThe purpose of this study was to compare once-daily tacrolimus with twice-daily tacrolimus in terms of safety, efficacy, and patient satisfaction.Materials and MethodsThis prospective, randomized, open-label, multicenter study was conducted at three institutes. Patients in the investigational group were converted from tacrolimus twice daily to the same dose of extended-release tacrolimus once daily at 1 month post-transplantation, while patients in the control group were maintained on tacrolimus twice daily. The efficacies, safeties, and patient satisfaction for the two drugs at 6 months post-transplantation were compared.ResultsSixty patients were enrolled and randomized to the investigational group (28 of 29 patients completed the study) or the control group (26 of 31 patients completed the study). At 6 months post-transplantation, composite efficacy failure rates including the incidences of biopsy-confirmed acute rejection in the investigational and control groups were 0% and 10.7%, respectively; patient survival was 100% in each group. No difference in estimated glomerular filtration rate values were observed at 6 months post-transplantation (p=0.97). The safety and satisfaction profile (immunosuppressant therapy barrier scale) of once-daily tacrolimus was comparable with that of twice-daily tacrolimus (p=0.35).ConclusionConversion from twice-daily tacrolimus to once-daily tacrolimus one month after transplantation is safe and effective.

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Section: Discussionsupporting

confidence: 77%

Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation

Huh

Lee

et al. 2014

Yonsei Med J

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“…Recently, the necessity of using higher doses of Tac QD to achieve a therapeutic level compared with the Tac BID dose in a kidney transplant has been reported [7][8][9][10], despite initial reports showing the bioequivalence of Tac QD with Tac BID. These reports suggest that lower Tac exposure is observed after conversion from Tac BID to Tac QD because of decreased bioavailability.…”

Section: Discussionmentioning

confidence: 99%

“…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]. However, several investigators have recently reported a sustained decrease in Tac exposure after conversion from Tac BID to Tac QD, and it is necessary to use a higher dose of Tac QD than Tac BID to achieve similar trough levels [7][8][9][10]. Therefore, the switch from Tac BID to Tac QD should be performed under close medical supervision.…”

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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“…15 One study found that, for patients taking relatively high doses of tacrolimus, the AUC was in a therapeutic range despite subtherapeutic trough levels, indicating that occasional AUC assessment may be useful in routine clinical practice with TAC QD. 20 Older patients (.60 years old) have been found to require lower doses of TAC QD than younger patients to achieve therapeutic trough levels. 21 The efficacy and safety data from 14 additional observational studies are consistent with the randomized controlled trial data (Table 1).…”

mentioning

confidence: 99%

“…21 The efficacy and safety data from 14 additional observational studies are consistent with the randomized controlled trial data (Table 1). [19][20][21][22][23][24][25][26][27][28][29][30][31][32] Although the effect of TAC QD versus TAC BID on adherence in de novo transplantation has not been systematically tested, an industry-sponsored modeling analysis that extrapolated the effect on adherence, as well as outcomes from a literature review of other studies of twiceversus once-daily medication, suggested that, after 5 years, graft survival would be 6.1% higher in the TAC QD group, which would result in a cost saving of US $9,411 per patient over the 5 years. 33 TAC QD is a useful treatment option that may reduce pill burden in patients adapting to life after transplantation, but an advantage in terms of efficacy or safety has not been demonstrated.…”

mentioning

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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Therapeutic Drug Monitoring in De Novo Kidney Transplant Receiving the Modified-Release Once-Daily Tacrolimus

Cited by 20 publications

References 9 publications

Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation

Safety and Efficacy of Conversion from Twice-Daily Tacrolimus to Once-Daily Tacrolimus One Month after Transplantation: Randomized Controlled Trial in Adult Renal Transplantation

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

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

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