Immunosuppression With Generic Tacrolimus and Mycophenolate Mofetil in Renal Transplant Recipients: Preliminary Report in Chile

A single-centre comparison of the clinical outcomes at 6 months of renal transplant recipients administered Adoport®or Prograf®preparations of tacrolimus

“…Three studies have evaluated the clinical outcomes of patients receiving generic tacrolimus preparations (including PanGraf ® and Tacro-Bell ® ) and have reported that these medications are safe and effective [4–6]. However, the reliability of these conclusions is undermined by the non-comparative nature of these studies.…”

Generic Immunosuppression: Deciphering the Message Our Patients are Receiving

“…8 In a study conducted to examine use of generic tacrolimus and mycophenolate mofetil as primary immunosuppression in renal transplant recipients, no biopsyproven acute rejection episodes, graft loss, or recipient deaths were observed. 9 These studies did not directly compare the generic formulations to the branded product.…”

“…5 There are limited efficacy data available to confirm therapeutic equivalency; studies have primarily examined short-term outcomes in patients with de novo kidney transplants receiving generic tacrolimus and mycophenolate mofetil. [6][7][8][9] Generic medications offer the advantage of decreased cost to the patient, health care system, and society, given therapeutic equivalency. There is debate as to whether the current indicators of generic safety and efficacy are adequate to determine therapeutic equivalency of immunosuppressive agents.…”

Next level of immunosuppression: Drug/immune monitoring

“…Moreover, bioequivalent studies are performed only in a limited number of healthy volunteers whose pharmacokinetics may be markedly different from those expected in LT recipients. For CNI therapy, some studies have shown equivalence or a lack of inferiority,18, 19 whereas others have reported more significant concerns and the need for dose adjustments and close monitoring 20, 21. Some studies comparing generic and brand name formulations of mycophenolate mofetil have shown reasonable bioequivalence 18, 22.…”