Label Changes for:

Afinitor (everolimus) Tablets

May 2011

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2011

 

WARNINGS AND PRECAUTIONS

Renal Failure Events
  • Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with Afinitor
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