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Important Safety Information
- There have been reports of noninfectious pneumonitis, infections, and renal failure (including acute renal failure) in patients taking AFINITOR® (everolimus) Tablets, some with fatal outcomes
- Oral ulceration is the most frequently occurring adverse event and occurred in 44% to 86% of AFINITOR-treated patients across the clinical trial experience. Most of these events were grade 1/2. Grade 3/4 stomatitis was reported in 4% to 9% of patients
- Elevations of serum creatinine, proteinuria, glucose, lipids, and triglycerides, and reductions of hemoglobin, lymphocytes, neutrophils, and platelets, have also been reported; monitoring of laboratory tests is recommended
- The use of live vaccines and close contact with those who have received live vaccines should be avoided
- AFINITOR can cause fetal harm when administered to a pregnant woman
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mTOR inhibition directly reduces tumor cell growth, proliferation, and metabolism, in addition to tumor angiogenesis*1-3
References: 1. Wullschleger S, Loewith R, Hall MN. TOR signaling in growth and metabolism. Cell. 2006;124:471-484. 2. Dancey JE. Inhibitors of the mammalian target of rapamycin. Expert Opin Investig Drugs. 2005;14:313-328. 3. Hartford CM, Ratain MJ. Rapamycin: something old, something new, sometimes borrowed and now renewed. Clin Pharmacol Ther. 2007;82:381-388.

