Rapamune Indications/Uses

Prophylaxis of Organ Rejection in Renal Transplantation: Rapamune is indicated for the prophylaxis of organ rejection in patients receiving a renal transplant.
In patients at low to moderate immunological risk, it is recommended that Rapamune be used initially in a regimen with cyclosporine and corticosteroids.
Cyclosporine should be withdrawn 2 to 4 months after transplantation, and the Rapamune dose should be increased to reach recommended blood concentrations (see Dosage & Administration). Cyclosporine withdrawal has not been studied in patients with Banff 93 grade III acute rejection or vascular rejection prior to cyclosporine withdrawal, those who are dialysis-dependent, or with serum creatinine >4.5 mg/dL, Black patients, renal re-transplants, multi-organ transplants, or patients with high-panel reactive antibodies (see Pharmacology: Pharmacodynamics under Actions).
In patients at high immunologic risk (defined as Black transplant recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high-panel reactive antibodies (PRA; peak PRA level >80%), it is recommended that Rapamune be used in a combination of tacrolimus and corticosteroids or cyclosporine and corticosteroids for the first year following transplantation (see Dosage & Administration and Pharmacology: Pharmacodynamics under Actions). The safety and efficacy of these combinations in high-risk renal transplant patients have not been studied beyond one year. Therefore, after the first year following transplantation, any adjustments to the immunosuppressive regimen should be considered on the basis of the clinical status of the patient.