Immunosuppression
• Immunosuppression may result in increased susceptibility to infection and possible development of lymphoma or other malignancies.
• Only clinicians experienced in immunosuppressive therapy and management of renal transplant patients should prescribe sirolimus.
• Patients should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources; the clinician responsible for maintenance therapy should have complete information for patient follow-up.

Use Not Recommended in Liver or Lung Transplant Patients
• Safety and efficacy of sirolimus as immunosuppressive therapy not established in liver or lung transplant patients; such use is not recommended. (See Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis in Liver Transplant Patients under Cautions and see Bronchial Anastomotic Dehiscence in Lung Transplant Patients under Cautions.)

REMS:

FDA approved a REMS for sirolimus to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).