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Label Changes for:

Rapamune (sirolimus) oral solution and tablets

September 2009

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009

BOX WARNING (revised)

  • WARNING: Immunosuppression, use is not recommended in liver or lung transplant patients


Liver Transplantation –- Excess Mortality, Graft Loss, and Hepatic Artery Thrombosis (HAT)
  • The safety and efficacy of Rapamune as immunosuppressive therapy have not been established in liver transplant patients; therefore, such use is not recommended. The use of Rapamune has been associated with adverse outcomes in patients following liver transplantation, including excess mortality, graft loss and Hepatic Artery Thrombosis (HAT).
  • In a clinical study in stable liver transplant patients 6-144 months post-liver transplantation and receiving a CNI-based regimen, an increased number of deaths was observed in the group converted to a Rapamune-based regimen compared to the group who was continued on a CNI-based regimen, although the difference was not statistically significant (3.3% versus 1.4%)