- Completion of sirolimus/blinded therapy in solid organ clinical trials (with or
without CsA) with satisfactory compliance and an adequate safety profile.
- Women of childbearing potential who have a negative pregnancy test before enrollment
into this study and who agree to practice either a hormonal or barrier method of
birth control throughout the treatment period and for 3 months following
discontinuation of sirolimus may be enrolled into the study.
- Signed and dated informed consent
- Unstable disease states, which in the opinion of the investigator would present a
risk to the patient.
- Known hypersensitivity to macrolide antibiotics