Generic Drug Immunosuppression in Thoracic Transplantation: An ISHLT Educational Advisory

Uber, Patricia A.; Ross, Heather J.; Zuckermann, Andreas; Sweet, Stuart C.; Corris, Paul A.; McNeil, Keith; Mehra, Mandeep R.

doi:10.1016/j.healun.2009.05.001

Cited by 46 publications

(33 citation statements)

References 16 publications

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“…Furthermore, bioequivalence between generics and brand products can vary considerably in patients, and there have been anecdotal reports of poor efficacy and safety after a switch to generic products. 15,17,18 Both formulations of tacrolimus assessed in the current study have well established efficacy, safety, and similar PK relationships.…”

Section: Figurementioning

confidence: 79%

“…15 Although generics may offer economic advantages, there are a number of issues to be aware of regarding their use, particularly with narrow therapeutic index agents such as tacrolimus, and when switching from the established, brand product. 16,17 The approval of a generic requires the demonstration of AUC 0 -24 , area under the curve from 0 to 24 hours; C 24 , concentration at 24 hours; CI, confidence interval; C max , maximum blood concentration.…”

Section: Discussionmentioning

confidence: 99%

“…15,17 However, this may not be deemed rigorous because healthy volunteers do not adequately represent the challenges faced in transplant patients. Furthermore, bioequivalence between generics and brand products can vary considerably in patients, and there have been anecdotal reports of poor efficacy and safety after a switch to generic products.…”

Section: Figurementioning

confidence: 99%

See 2 more Smart Citations

Pharmacokinetics in stable heart transplant recipients after conversion from twice-daily to once-daily tacrolimus formulations

Alloway

Vanhaecke

Yonan

et al. 2011

The Journal of Heart and Lung Transplantation

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Section: Figurementioning

confidence: 79%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics in stable heart transplant recipients after conversion from twice-daily to once-daily tacrolimus formulations

Alloway

Vanhaecke

Yonan

et al. 2011

The Journal of Heart and Lung Transplantation

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“…Generics are widely and successfully used across clinical practice; in the Netherlands in 2009, for example, 57% of prescriptions were dispensed as generic products 9. However, NTI immunosuppressive drugs bring their own particular considerations, as small variations in drug concentrations in the blood could result in reduced immunosuppression or increased toxicity, with potentially adverse effects on patient outcomes 2 8 10…”

Section: Introductionmentioning

confidence: 99%

Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation

Johnston¹

2013

Eur J Hosp Pharm

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The calcineurin inhibitors (CNIs), ciclosporin and tacrolimus, are the mainstay of immunosuppression in solid organ transplantation. Generic formulations of these drugs are now available. With increasing pressure on healthcare budgets and the consequent need to match health expectations to available resources, substitution with a generic product appears an attractive option to reduce costs. Approval of generic products differs from innovator drugs, and narrow therapeutic index drugs (NTIs; including CNIs) bring their own particular considerations. With NTIs, small variations in drug exposure could result in reduced immunosuppression or drug toxicity with potentially adverse effects on patient outcomes. NTIs are subject to stricter regulatory approval versus many other generic drugs. However, different generic formulations may still not necessarily be therapeutically equivalent in individuals, raising the possibility of significant differences in exposure between products. Although regional recommendations vary, many guidelines emphasise the need for NTI drug substitution to be initiated by the transplant physician, thus ensuring careful therapeutic monitoring and reduced negative patient impact. The need for therapeutic monitoring during generic substitution has important implications for the overall costs of generic treatment as these costs have to be factored in to the potential savings made from using generic formulations. The reduced acquisition costs of generic products may not necessarily translate into lower overall healthcare costs. This article examines the issue of equivalence and interchangeability of NTI drugs used in organ transplantation, the implications of the approval process for generic drugs on treatment efficacy and safety, and the effective management of substitutions between products.

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“…Generic tacrolimus is now available and patients, pharmacies, and payers have a strong interest in minimizing post-transplant expenses. Transplant programs have expressed concern about the bioequivalence, efficacy, and safety of generic tacrolimus compared to Prograf [2][3][4], and the decision of whether to use generic tacrolimus is presently center-specific. In late 2009, we elected to permit hearttransplant patients to begin their de novo calcineurin inhibitor with generic tacrolimus rather than Prograf, as the frequent monitoring in the early post-transplant period was thought to provide the largest margin of safety.…”

Section: Introductionmentioning

confidence: 99%

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

Dhungel¹,

Colvin-Adams²,

Eckman³

2013

OJOTS

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Calcineurin inhibitors are the cornerstone of solid organ transplant immunosuppression. Tacrolimus has only recently become available in a non-branded formulation, and there is little data on the efficacy and safety of generic tacrolimus, particularly following heart transplant. We 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 Prograf. No significant difference in biopsy-proven acute cellular rejection was noted between the groups and rates of opportunistic infection and death were comparable. Although limited by the single-center, retrospective design, this preliminary data may be useful to clinicians facing the option of initiating generic tacrolimus following heart transplant.

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Generic Drug Immunosuppression in Thoracic Transplantation: An ISHLT Educational Advisory

Cited by 46 publications

References 16 publications

Pharmacokinetics in stable heart transplant recipients after conversion from twice-daily to once-daily tacrolimus formulations

Pharmacokinetics in stable heart transplant recipients after conversion from twice-daily to once-daily tacrolimus formulations

Equivalence and interchangeability of narrow therapeutic index drugs in organ transplantation

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

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