Label Changes for:
Rapamune (sirolimus) oral solution and tablets
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
WARNINGS AND PRECAUTIONS
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%)