After failure of first-line VEGFR-TKIs sunitinib or sorafenib in aRCC, look to

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AFINITOR® (everolimus) Tablets is indicated for the treatment of adults with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

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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, some with fatal outcomes
  • Oral ulceration is the most frequently occurring adverse event and occurred in 44% to 78% 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
  • Exercise caution with the use of AFINITOR in the perisurgical period, as everolimus delays wound healing and increases the occurrence of wound-related complications
  • 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

Please see additional Important Safety Information.

Please see full Prescribing Informationfor AFINITOR.

Abbreviations: aRCC, advanced renal cell carcinoma; PFS, progression-free survival; VEGFR-TKI, vascular endothelial growth factor receptor-tyrosine kinase inhibitor.

 

Important Safety Information

AFINITOR is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.

Noninfectious Pneumonitis:

Infections:

Oral Ulceration:

Renal Failure:

Impaired Wound Healing:

Laboratory Tests and Monitoring:

Drug-Drug Interactions:

Hepatic Impairment:

Vaccinations:

Embryo-Fetal Toxicity:

Adverse Reactions:

Laboratory Abnormalities:

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for AFINITOR.

References: 1. AFINITOR [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2014. 2. Motzer RJ, Escudier B, Oudard S, et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma. Cancer, 2010;116:4256-4265. 3. Yuan R, Kay A, Berg W, Lebwohl D, Targeting tumorigenesis: development and use of mTOR inhibitors in cancer therapy. J Hematol Oncol. 2009;2:45.