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Quantification of the Immunosuppressant Tacrolimus on Dried Blood Spots Using LC-MS/MS
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Generic immunosuppressants.

Mara Medeiros1,2, Julia Lumini3, Noah Stern4

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|July 23, 2017
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Summary
This summary is machine-generated.

Generic immunosuppressants in organ transplantation pose risks due to inconsistent bioequivalence. Brand prescribing for cyclosporine and tacrolimus is recommended to prevent adverse events and ensure patient safety.

Keywords:
AntimetabolitesCalcineurin inhibitorsMMFSirolimusTacrolimusmTOR inhibitors

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Area of Science:

  • Pharmacology
  • Transplantation Medicine
  • Drug Bioequivalence

Background:

  • Immunosuppressive drugs are critical for solid organ transplantation.
  • Generic versions offer cost savings but raise safety concerns.
  • Adverse events have been reported following transitions to generic immunosuppressants, particularly in pediatric recipients.

Purpose of the Study:

  • To review regulatory criteria for demonstrating bioequivalence of generic immunosuppressants.
  • To assess major immunosuppressive drugs against these recommendations.
  • To identify strategies for minimizing risks associated with generic immunosuppressant use.

Main Methods:

  • Review of regulatory guidelines for drug bioequivalence.
  • Analysis of available bioequivalence data for key immunosuppressive medications.
  • Examination of reported adverse events linked to innovator-to-generic drug switching.

Main Results:

  • Regulatory criteria for bioequivalence are inconsistent across different bodies.
  • Approved generic immunosuppressants exhibit variable degrees of equivalence to innovator drugs.
  • Cyclosporine and tacrolimus show evidence of adverse events upon switching to generics due to dissolution differences.

Conclusions:

  • Brand prescribing of cyclosporine and tacrolimus is advised to mitigate risks.
  • While Mycophenolate Mofetil (MMF) generally shows better bioequivalence, caution is still warranted.
  • Consideration of 'innovator only' policies may be necessary until more stringent bioequivalence standards are established.