The “generic” effect of food on tacrolimus pharmacokinetics

Steiner, Robert W.; Feist, A.

doi:10.1111/j.1399-0012.2010.01387.x

Cited by 8 publications

(5 citation statements)

References 3 publications

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“…Also, due to the more rapid relative growth of younger children, their TCL dose has to be adjusted more often and these changes may affect the trough concentrations to a higher extent. Furthermore, pharmacokinetics of TCL is multi‐factorial and closely related to the maturity of the cytochrome P450 and its genetic polymorphisms (5), concomitant use of corticosteroids (19), hematocrit level (5), body weight (5) and food ingestion (20).…”

Section: Discussionmentioning

confidence: 99%

Intra‐patient variability in tacrolimus trough concentrations and renal function decline in pediatric renal transplant recipients

Prytuła

Bouts

Mathôt

et al. 2012

Pediatric Transplantation

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High intra-patient variability in TCL exposure is a risk factor for allograft loss and late acute rejection. We hypothesized that a higher intra-patient variability leads to a faster decline in GFR in pediatric renal transplant patients and that adolescents have a higher intra-patient variability due to poorer adherence. We included 69 children aged 3.5-18 yr who had undergone renal transplantation between April 1996 and May 2009 in two pediatric nephrology centers in the Netherlands. We analyzed TCL trough concentrations over a period of one yr and calculated TCL trough concentrations variability using VC. We investigated the correlation between the TCL trough concentrations variability and the decline in estimated GFR over four yr. The median intra-patient variability in TCL concentrations was 30.1% (range 8.6-77.6) and the mean GFR slope -3.8 mL/min/1.73 m(2) /yr. The VC correlated neither with the GFR slope, nor with the patients' age. However, children with late acute rejection had higher VC (p = 0.045). We were unable to provide evidence that a high variability in TCL exposure leads to a faster decline in renal function, although children with late acute rejection have a higher variability in TCL exposure. Adolescents do not have a higher intra-patient variability in TCL trough concentrations than younger children.

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Section: Discussionmentioning

confidence: 99%

Intra‐patient variability in tacrolimus trough concentrations and renal function decline in pediatric renal transplant recipients

Prytuła

Bouts

Mathôt

et al. 2012

Pediatric Transplantation

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“…Another limitation is that we only analyzed clinically available 12‐hour trough blood drug concentrations to estimate bioequivalence, rather than formal PK studies including C max and AUC. In pediatric populations, PK studies would be especially difficult due to the need for frequent blood draws, and requirement for fasting during testing . However, strong linear correlation has been shown between AUC and 12‐hour trough concentration for Sandoz generic in adults , and for brand tacrolimus in children .…”

Section: Discussionmentioning

confidence: 99%

Transition from brand to generic tacrolimus is associated with a decrease in trough blood concentration in pediatric heart transplant recipients

Duong

Lal

Joshi

et al. 2015

Pediatric Transplantation

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There are limited data available on the bioequivalence of generic and brand-name tacrolimus in pediatric and heart transplant patients. We characterized changes in 12-hour trough concentrations and clinical outcomes after transition from brand to generic tacrolimus in pediatric thoracic organ transplant recipients. Patients with a pharmacy-confirmed date of switch between generic and brand tacrolimus were identified, as well as a matched control group that did not switch for comparison. We identified 18 patients with a confirmed date of switch, and in 12 patients that remained on the same dose, trough concentrations were 14% less than when they were on brand (p = 0.037). The average change was -1.15 ± 1.76 ng/mL (p = 0.045). The control group did not experience a change in trough concentration and was different than the switched group (p = 0.005). There were no differences in dosage changes or kidney or liver function. In the year after switch, 24% of patients who were switched to generic experienced a rejection event vs. 18% in the patients on brand. We suggest a strategy of monitoring around the time of transition, and education of the patient/family to notify the care team when changes from brand to generic or between generics occur.

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“…Depending on the method by which a transplant recipient takes his or her medication, there can be wide variations in levels. The effect of food on calcineurin inhibitor absorption has been reported 15,16 and can account for much of the fluctuation in levels seen in the inpatient setting. The authors advocate a strict empty stomach immunosuppression protocol for all transplant recipients to minimize this fluctuation in levels and to ensure adequate drug exposure.…”

Section: How Should Immunosuppressive Medications Be Monitored While mentioning

confidence: 97%

Inpatient Management of Postrenal Transplant Patients

Mapakshi

Huang

Shah

2013

Hospital Medicine Clinics

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The “generic” effect of food on tacrolimus pharmacokinetics

Cited by 8 publications

References 3 publications

Intra‐patient variability in tacrolimus trough concentrations and renal function decline in pediatric renal transplant recipients

Intra‐patient variability in tacrolimus trough concentrations and renal function decline in pediatric renal transplant recipients

Transition from brand to generic tacrolimus is associated with a decrease in trough blood concentration in pediatric heart transplant recipients

Inpatient Management of Postrenal Transplant Patients

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