When RAPAMUNE® is taken with cyclosporine or tacrolimus, you may develop a blood clotting problem resulting in unexplained bleeding or bruising.

Common side effects associated with RAPAMUNE® include high blood pressure, pain (including stomach and joint pain), diarrhea, headache, fever, urinary tract infection, low red blood cell count (anemia), nausea, and low platelet count (cells that help blood to clot). If you experience any side effects, contact your doctor.

RAPAMUNE® Indications and Usage

RAPAMUNE® (sirolimus) is indicated for the prevention of organ rejection in kidney transplant patients aged 13 years or older. Blood levels of sirolimus should be checked in all patients taking RAPAMUNE®.

In patients at low to moderate risk of acute rejection, it is recommended that RAPAMUNE® be used initially in combination with cyclosporine and corticosteroids; cyclosporine should be withdrawn approximately 3 months after transplantation. Cyclosporine withdrawal has not been studied in patients who have had severe acute rejection prior to cyclosporine withdrawal, those who require dialysis or have a high serum creatinine, Black patients, patients receiving a repeat kidney transplant, patients receiving other transplanted organs besides the kidney transplant, or patients with antibodies that may be directed against the kidney transplant.

In patients at high risk of acute rejection (defined as Black patients and/or patients receiving a repeat kidney transplant who lost a previous kidney transplant from rejection and/or patients with high levels of antibodies that may be directed against the kidney transplant), it is recommended that RAPAMUNE® be used in combination with cyclosporine and corticosteroids for the first year following transplantation. The safety and efficacy of this combination in high-risk patients have not been studied beyond one year; therefore, after the first year, adjustments to the immunosuppressive regimen may be considered by your doctor.

In pediatric patients, the safety and efficacy of RAPAMUNE® have not been established in kidney transplant patients less than 13 years old, or in patients less than 18 years old who are considered at high risk of acute rejection.

The safety and efficacy of RAPAMUNE® without cyclosporine in newly transplanted kidney patients have not been established.

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