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U.S. Department of Health and Human Services

Safety

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Neoral (cyclosporine) Modified soft gelatin capsules and oral solution

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2009

 

Summary View

 

WARNINGS

Kidney, Liver and Heart Transplant/Latent Viral Infections
  • Immunosuppressed patients are at increased risk for opportunistic infections, including activation of latent viral infections. These include BK virus-associated nephropathy which has been observed in patients receiving immunosuppressants, including Neoral. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss. Patient monitoring may help detect patients at risk for BK virus-associated nephropathy. Reduction in immunosuppression should be considered for patients who develop evidence of BK virus-associated nephropathy.

ADVERSE REACTIONS

Postmarketing Experience/Kidney, Liver and Heart Transplantation
  • BK virus associated nephropathy has been observed in patients receiving immunosuppressants, including Neoral. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.