Labeling change for immunosuppressants used in kidney transplant rejection prophylaxis

The FDA is requiring manufacturers of some immunosuppressants used in the prevention of kidney transplant rejection to update their labeling to reflect an increased risk of infections. This action is based on the FDA’s review of reported adverse events. The labeling change must reflect the reported increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus-associated nephropathy. Such infections may lead to serious outcomes, including kidney graft loss.

Labeling changes are required for the following immunosuppressants: Rapamune (sirolimus, from Wyeth), Sandimmune (cyclosporine, from Novartis), Neoral (cyclosporine [modified], from Novartis), Cellcept (mycophenolate mofetil, from Roche), and Myfortic (mycophenolic acid, from Novartis). The labeling for Prograf (tacrolimus, from Astellas) already includes the increased risk for opportunistic infections.

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