Pill Identifier App

Label Changes for:

Rapamune (sirolimus) oral solution and tablets

October 2009

Changes have been made to the WARNINGS and ADVERSE REACTIONS sections of the safety label.

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

WARNINGS AND PRECAUTIONS

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 Rapamune. 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/Infections
  • BK virus associated nephropathy has been observed in patients receiving immunosuppressants, including Rapamune. This infection is associated with serious outcomes, including deteriorating renal function and renal graft loss.
Hide
(web1)