Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail
-

Sandimmune (cyclosporine) injection, oral solution, and soft gelatin capsules

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

 

Summary View

 

WARNINGS

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 Sandimmune. 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
  • BK virus associated nephropathy has been observed in patients receiving immunosuppressants, including Sandimmune. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.
-
-