Label Changes for:
Afinitor (everolimus) Tablets
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