FDA Drug Safety Communication

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FDA Date: 7/13/09

Rapamune (sirolimus) FDA Drug Safety Communication

Information for Healthcare Professionals: Immunosuppressant Drugs: Required Labeling Changes

FDA is requiring the makers of certain immunosuppressant drugs to update their labeling to reflect that immunosuppressed patients are at increased risk for opportunistic infections, such as activation of latent viral infections, including BK virus-associated nephropathy. Class labeling changes are required for the following immunosuppressant drugs:

- sirolimus, marketed as Rapamune

- cyclosporine, marketed as Sandimmune and generics

- cyclosporine modified, marketed as Neoral and generics

- mycophenolate mofetil, marketed as Cellcept and generics

- mycophenolic acid, marketed as Myfortic

This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

View the full FDA Drug Safety Communication on FDA.gov