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
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T99-42 Print Media: 301-827
September 15, 1999 Broadcast Media: 301-827
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FDA APPROVES RAPAMUNE TO PREVENT ORGAN
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
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
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
Rapamune is manufactured by Wyeth Ayerst Laboratories of