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U.S. Department of Health and Human Services


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Afinitor (everolimus) Tablets

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


July 2014

Summary View


Non-infectious Pneumonitis
  • … Opportunistic infections such as pneumocystis jiroveci pneumonia (PJP) should be considered in the differential diagnosis. For patients who require use of corticosteroids for treatment of non-infectious pneumonitis, prophylaxis for PJP may be considered...
  • ...Localized and systemic infections, including… or pneumocystis jiroveci pneumonia (PJP)…
  • Pneumocystis jiroveci pneumonia, some with a fatal outcome, has been reported in patients who received everolimus. This may be associated with concomitant use of corticosteroids or other immunosuppressive agents. Prophylaxis for PJP should be considered when concomitant use of corticosteroids or other immunosuppressive agents are required.


Postmarketing Experience
  • The following adverse reactions … cholecystitis, cholelithiasis, arterial thrombotic events and reflex sympathetic dystrophy


February 2014

Summary View


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)].


6.2 Clinical Study Experience in Advanced Pancreatic Neuroendocrine Tumors
  • irregular menstruation…percentage increased … occurred in 5 of 46 (11%)



May 2011

Summary View


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