(1999; 30 pages)
Sirolimus - approved for prevention of organ rejection: USA
United States of America. The Food and Drug Administration has approved sirolimus (Rapamune: Wyeth Ayerst), a new immunosuppressant drug, to prevent acute organ rejection in patients receiving kidney transplants, to be taken in conjunction with ciclosporin and corticosteroids.
Sirolimus 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.
Adverse events associated with the use of sirolimus 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 sirolimus.
Patients treated with ciclosporin and sirolimus 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 sirolimus.
A daily dose of 2 mg is recommended for use in renal transplant patients after an initial dose of 6 mg. Sirolimus should be taken consistently either with or without food. The drug is administered as a liquid mixed with water or orange juice. Grapefruit juice should not be consumed with sirolimus or used for dilution.
Reference: FDA Talk Paper T99-42 dated 15 September 1999.