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US Food and Drug Administration

FDA approves rapamune to prevent organ rejection

FDA Talk Paper (Sep) T99:42 1999


Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857

FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

T99-42                                           Print Media:         301-827
September 15, 1999                               Broadcast Media:     301-827
                                                 Consumer Inquiries:  888-


FDA today approved Rapamune (sirolimus), a new immunosuppressant drug, to prevent acute organ rejection in patients receiving kidney transplants. This new drug is to be taken along with cyclosporine and corticosteroids.

Rapamune acts by a mechanism that is not redundant with other immunosuppressants used to prevent graft rejection in kidney transplantation. It has few overlapping toxicities with existing therapy, and represents an important addition to the limited number of available immunosuppressants in kidney transplantation.

The safety and efficacy of Rapamune is supported by two clinical studies. One study was conducted in the United States at 38 sites in which 719 patients were enrolled. The other study involved 576 patients at 34 sites in Australia, Canada, Europe, and the United States.

Adverse events associated with the use of Rapamune included an increase in serum cholesterol and triglycerides. New-onset high cholesterol, which required treatment with lipid-lowering drugs, developed in a significant proportion of patients taking Rapamune.

Patients treated with cyclosporine and Rapamune were also noted to have higher serum creatinine levels. Renal function should be monitored and appropriate adjustment of the immunosuppression regimen should be considered in patients with elevated serum creatinine levels.

Increased susceptibility to infection and the possible development of lymphoma may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should use Rapamune.

A daily dose of 2 mg is recommended for use in renal transplant patients after an initial dose of 6 mg. Rapamune should be taken consistently with or without food. The drug is administered as a liquid mixed with water or orange juice. Grapefruit juice should not be consumed with Rapamune or used for dilution.

Rapamune is manufactured by Wyeth Ayerst Laboratories of Philadelphia, Penna.