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Sirolimus

Immunosuppression, Use Not Recommended in Liver or Lung Transplant Patients

  • Increased susceptibility to infection and the possible development of lymphoma and other malignancies┬ámay result from immunosuppression.
  • The safety and efficacy of sirolimus as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended.

Qualified Physician/Equipped Facility

  • Only physicians experienced in immunosuppressive therapy and management of renal transplant patients should use sirolimus.
  • Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
  • The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient .

Liver Transplantation- Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis (HAT)

  • 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.
  • In this and another study in de novo liver transplant patients, the use of sirolimus in combination with cyclosporine or tacrolimus was associated with an increase in HAT; most cases of HAT occurred within 30 days post-transplantation and most led to graft loss or death.

Lung Transplantation- Bronchial Anastomotic Dehiscence

  • Cases of bronchial anastomotic dehiscence, most fatal, have been reported in de novo lung transplant patients when sirolimus has been used as part of an immunosuppressive regimen.
  • The safety and efficacy of sirolimus as immunosuppressive therapy have not been established in liver or lung transplant patients, and therefore, such use is not recommended.

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Sirolimus

Additional Information

Updated January 2018