Short-Term Outcomes in Heart Transplant Recipients Treated with Generic Tacrolimus Compared to Prograf

Dhungel, Vinayak; Colvin-Adams, Monica; Eckman, Peter

doi:10.4236/ojots.2013.32004

Cited by 4 publications

(3 citation statements)

References 5 publications

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“…Dhungel et al published outcomes of 21 de novo heart transplant recipients. Although outcomes such as rejection and death rates were similar between brand and generic groups, no direct comparisons of troughs were made (12). In Spence et al's retrospective study of 217 patients, 12 patients were stable adult heart recipients.…”

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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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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“…The use of generic tacrolimus in heart transplant patients has only been studied twice before: in 21 de novo patients by Dhungel et al. and in 12 stable patients by Spence et al. .…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients

Söderlund

Rådegran

2015

Clinical Transplantation

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“…Dhungel et al. have performed a retrospective analysis of 21 consecutive patients who were treated with generic tacrolimus following heart transplant and compared rate of biopsy‐proven acute cellular rejection to historical controls who were treated with innovator drug. No significant difference in biopsy‐proven acute cellular rejection was noted between the groups, and rates of opportunistic infection and death were comparable.…”

Section: Clinical Evidence For Conversionmentioning

confidence: 99%

Generic tacrolimus in solid organ transplantation

Taube¹,

Jones

Wennberg

et al. 2014

Clinical Transplantation

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The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation (SOT). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which are similar in quality, safety, and efficacy to their approved innovator drugs. There are data available for three generic brands, tacrolimus (Intas), tacrolimus (PharOS), and tacrolimus (Sandoz). Bioequivalence has been demonstrated for generic tacrolimus (Sandoz) within a narrow therapeutic range to its innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other SOT patients, including lung and heart recipients.

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Short-Term Outcomes in Heart Transplant Recipients Treated with Generic Tacrolimus Compared to Prograf

Cited by 4 publications

References 5 publications

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

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

Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients

Generic tacrolimus in solid organ transplantation

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