Rapamune / Sirolimus

Modified on 2009/10/14 21:50 by admin
Rapamune (sirolimus), an immunosuppressant drug, is indicated for the prevention of acute organ rejection in patients receiving kidney transplants. The drug is taken in combination with cyclosporine and corticosteroids. Rapamune, manufactured by Wyeth Pharmaceuticals and approved by the U.S Food and Drug Administration in 1998, 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 Rapamune include an increase in serum cholesterol and triglycerides. New-onset high cholesterol, which requires treatment with lipid-lowering drugs, has developed in a significant proportion of patients taking Rapamune. Patients treated with cyclosporine and Rapamune are 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 distribute 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. On April 24, 2002, Wyeth Pharmaceuticals sent members of the American Society of Transplantation and The American Society of Transplant Surgeons a "Dear Healthcare Provider" letter concerning the safety of Rapamune. The letter informs clinicians of the risk of hepatic artery thrombosis, graft loss, and death associated with the use of Rapamune in de novo liver transplantation.

In February 2003, Wyeth, in cooperation with the FDA, notified healthcare professionals of post-marketing reports of bronchial anastomotic dehiscence, including fatal cases, in lung transplant patients treated with Rapamune in combination with tacrolimus and corticosteroids. Patients reportedly experienced a rupture of the surgical connection between the donated lungs and bronchial tubes. Four patients died. The safety and efficacy of Rapamune as immunosuppressive therapy has not been established in lung transplant patients.

See your doctor if you have experienced an adverse reaction after using Rapamune. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

See Also

  1. Transplantation & Immunosuppressant Drugs: Overview
  2. Liver Problems
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