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Sirolimus (marketed as Rapamune)


FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations.

Recommendations and Information for Healthcare Professionals:

  • Sirolimus is indicated for the prophylaxis of organ rejection in patients aged 13 years or older receiving kidney transplants.
  • The safety and the efficacy of sirolimus as an immunosuppressant have not been established in liver or lung transplant patients. This information is in the Boxed Warning of the sirolimus label.
  • The current Boxed Warning of sirolimus indicates that the use of sirolimus in combination with tacrolimus was associated with excess mortality and graft loss in a study in de novo liver transplant patients. Many of these patients had evidence of infection at or near the time of death.
  • Therapeutic drug monitoring is recommended for all patients receiving sirolimus.
  • Therapeutic drug monitoring should not be the sole basis for adjusting sirolimus therapy. Careful attention should be paid to clinical signs and symptoms, tissue biopsy findings, and laboratory parameters.
  • Patients unable to take the tablets should be prescribed the sirolimus oral solution and instructed in its use.
  • Patients should be counseled that sirolimus is to be taken by mouth, once a day, consistently and with or without food.
  • Sirolimus tablets should not be crushed, chewed or split.

Source: U.S. Food and Drug Administration