Generic tacrolimus in solid organ transplantation

@article{Taube2014GenericTI,
  title={Generic tacrolimus in solid organ transplantation},
  author={David H. Taube and G. V. Jones and James O’Beirne and Lars Wennberg and Andrew Connor and Allan Rasmussen and Lars Backman},
  journal={Clinical Transplantation},
  year={2014},
  volume={28}
}
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… 
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Generic Tacrolimus (Tacrobell®) Shows Comparable Outcomes to Brand-Name Tacrolimus in the Long-Term Period After Adult Deceased Donor Liver Transplantation
TLDR
It is shown that generic tacrolimus is an alternative comparable to brand-name tacolimus in adult DDLT patients, and increased recipient age, continuous renal replacement therapy in the pre-transplant phase, and acute rejection were predisposing factors for patient death.
Transition from brand to generic tacrolimus is associated with a decrease in trough blood concentration in pediatric heart transplant recipients
TLDR
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 are suggested.
Kinetics of generic tacrolimus in heart transplantation: A cautionary note.
  • Z. Il'giovine, J. B. Williams, +5 authors R. Starling
  • Medicine
    The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation
  • 2021
Pharmacokinetics and Clinical Outcomes of Generic Tacrolimus (Hexal) Versus Branded Tacrolimus in De Novo Kidney Transplant Patients: A Multicenter, Randomized Trial
TLDR
Tacrolimus pharmacokinetics is similar with TacHexal and Prograf early after kidney transplantation, with at least equivalent graft function under TacH Hexal.
Nationwide conversion to generic tacrolimus in pediatric kidney transplant recipients
TLDR
Pediatric renal transplant recipients can be converted from Tacrolimus Prograf® to Sandoz® with negligible change in trough concentration, dose adjustments, or immediate allograft function.
Generic immunosuppression: Should we be worried?
TLDR
A meta-analysis concluded that there was a lack of bioequivalence for Neoral (cyclosporine), Prograf (tacrolimus), and Cellcept (mycophenolate mofetil) in adult kidney transplant patients, but no difference in acute rejection, as highlighted in this issue of Pediatric Transplantation.
Differences in Peripheral Blood Lymphocytes between Brand-Name and Generic Tacrolimus Used in Stable Liver Transplant Recipients
TLDR
The finding showed that brand-name tacrolimus could have more potential immunosuppressive activity than generic tacolimus regarding the contribution of CD4+Foxp3+ T cells to graft tolerance in liver transplant recipients.
EASL Clinical Practice Guidelines: Liver transplantation.
The adoption of generic immunosuppressant medications in kidney, liver, and heart transplantation among recipients in Colorado or nationally with Medicare part D
  • Qian Liu, Abigail R. Smith, +13 authors J. Zee
  • Medicine
    American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
  • 2018
TLDR
Overall, generic substitution for tacrolimus and mycophenolate mofetil for organ transplant recipients increased rapidly following first availability, and utilization of generic immunosuppressants exceeded that of brand‐name products within a year of market entry.
Common issues in the management of patients in the waiting list and after liver transplantation.
  • P. Burra, L. Belli, +4 authors P. Toniutto
  • Medicine
    Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
  • 2017
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References

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TLDR
Results suggest that transplant patients currently taking the reference tacrolimus formulation may be safely switched to the Sandoz‐generic product provided trough concentrations are closely monitored following the substitution.
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TLDR
Caution in the use of generic immunosuppressive drugs in solid organ transplantation is warranted because published evidence supporting therapeutic equivalence of generic formulations in SOTR is lacking and the potential for uncontrolled product switching is a major concern.
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TLDR
Although more research is needed to confirm clinical and therapeutic equivalence and pharmacoeconomic benefit, generic immuno‐suppressants can be safely substituted for innovator products as long as patients consistently receive the same product, patients and clinicians are aware of when substitutions occur, and enhanced therapeutic drug monitoring is provided during the transition.
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TLDR
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TLDR
Stable kidney transplant patients treated with Prograf® can be converted to Tacrolimus Sandoz® if trough concentrations of tacolimus and plasma creatinine levels are closely monitored and the conversion brought savings, despite costs for extra monitoring.
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TLDR
The relationship between C0 and the AUC in patients receiving Adoport during the acute phase after renal transplantation was evaluated to evaluate the relationship between the exposure to the drug and the surrogate marker may vary between formulations.
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TLDR
C cumulative data show that dose requirements and trough levels are similar between brand and generic tacrolimus and that generic substitution allows for savings, however, postconversion monitoring is prudent as patients may require dose titration.
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TLDR
Critics have started to question current reliance on trough measurement during therapeutic drug monitoring, with instances of toxicity and rejection occurring when trough concentrations are within ‘acceptable’ ranges, and controversy exists as to whether this will provide any great benefit, given the added complexity in monitoring.
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TLDR
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TLDR
In 2001, the American Society of Transplantation invited experts to review the data and issues associated with the approval and use of generic immunosuppressants.
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