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Information for Healthcare Professionals: Immunosuppressant Drugs: Required Labeling Changes

[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)]

 

FDA ALERT [07/14/2009]:  

The U.S. Food and Drug Administration (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.  These immunosuppressant drugs are used to protect against the rejection of certain organ transplants.

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

The FDA conducted analyses of its Adverse Event Reporting System (AERS) to characterize the association between BK virus-associated nephropathy and the use of these immunosuppressant drugs. The occurrence of BK virus-associated nephropathy is primarily observed in renal transplant patients.  

BK virus-associated nephropathy can progress to renal allograft loss. Monitoring for this serious risk and early intervention by the health care provider is critical. Adjustments in immunosuppression therapy should be considered for patients who develop BK virus-associated nephropathy. 

The association of BK virus-associated nephropathy has previously been reported for another immunosuppressant drug, tacrolimus (marketed as Prograf).  Information about the increased risk for opportunistic infections, including activation of latent viral infections, is included in the prescribing information for Prograf. Currently the prescribing information for the other immunosuppressant drugs does not adequately warn about this possible serious adverse event. Based on this new safety information, FDA is requiring, under the authorities granted under the Food and Drug Administration Amendments Act (FDAAA) of 2007, that manufacturers of these immunosuppressants update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy

This information reflects FDA’s current analysis of data available to FDA concerning these products. FDA intends to update this document when additional information or analyses become available.

FDA is continuing to review the safety of immunosuppressant drug products used in renal transplantation.  The FDA urges both healthcare professionals and patients to report side effects from the use of immunosuppressant drug products to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this sheet.

 

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