Immunosuppression, Use Not Recommended in Liver or Lung Transplant Patients

• Increased susceptibility to infection and the possible development of lymphoma and other malignancies may 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.