- Cardiac transplant recipients age 18 years or older receiving cyclosporine or
tacrolimus since the time of transplant.
- 12 months after cardiac transplantation but less than 96 months post-transplantation.
- Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after
kidney transplant recipients).
- Prior or current use of sirolimus or everolimus unless administration was part of a
"CNI holiday" lasting no more than 10 days.
- History of acute rejection within the last 3 months, malignancy within the last 5
years (except for adequately treated basal cell or squamous cell carcinoma of the
skin), and human immunodeficiency virus (HIV) patients.