Label Changes for:
Afinitor (everolimus) Tablets for Oral AdministrationAfinitor Disperz (everolimus tablets for oral suspension)
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)
5 WARNINGS AND PRECAUTIONS
5.5 Impaired Wound Healing
- Everolimus delays wound healing and increases the occurrence of wound-related complications like wound dehiscence, wound infection, incisional hernia, lymphocele, and seroma. These wound-related complications may require surgical intervention. Exercise caution with the use of AFINITOR in the peri-surgical period.
5.11 Embryo-fetal Toxicity
- Based on the mechanism of action, AFINITOR can cause fetal harm. Everolimus caused embryo-fetal toxicities in animals at maternal exposures that were lower than human exposures. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)]. Advise female patients of reproductive potential to avoid becoming pregnant and to use highly effective contraception while using AFINITOR and for up to 8 weeks after ending treatment [see Use in Specific Populations (8.6)].
6 ADVERSE REACTIONS
6.2 Clinical Study Experience in Advanced Pancreatic Neuroendocrine Tumors
- irregular menstruation…percentage increased … occurred in 5 of 46 (11%)
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