Up to 70% of cases of breast cancer have mutations in the PI3K/Akt/mTOR pathway; hyperactivation of this pathway can contribute to endocrine resistance1-5


*Median PFS was 7.8 months with AFINITOR plus exemestane [95% CI, 6.9-8.5] vs 3.2 months [95% CI, 2.8-4.1] with placebo plus exemestane (HR=0.45 [95% CI, 0.38-0.54]; P<0.0001).1

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AFINITOR® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.

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Important Safety Information

  • AFINITOR is contraindicated in patients with hypersensitivity to everolimus, other rapamycin derivatives, or any excipients
  • 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
  • In the randomized advanced hormone receptor-positive, HER2-negative breast cancer study, the incidences of deaths due to any cause within 28 days of the last AFINITOR dose and adverse reactions leading to permanent treatment discontinuation were greater in patients ≥65 years of age compared with patients <65 years of age
  • 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 Information for AFINITOR.


Important Safety Information

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

Noninfectious Pneumonitis:


Oral Ulceration:

Renal Failure:

Impaired Wound Healing:

Geriatric Patients:

Laboratory Tests and Monitoring:

Drug-Drug Interactions:

Hepatic Impairment:


Embryo-Fetal Toxicity:

Adverse Reactions:

Laboratory Abnormalities:

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

Please see full Prescribing Information for AFINITOR.

References: 1. Johnston SRD. Enhancing the efficacy of hormonal agents with selected targeted agents. Clin Breast Cancer. 2009;9(suppl 1):S28-S36. 2. Di Cosimo S, Baselga J. Management of breast cancer with targeted agents: importance of heterogeneity. Nat Rev Clin Oncol. 2010;7(3):139-147. 3. Shou J, Massarweh S, Osborne CK, et al. Mechanisms of tamoxifen resistance: increased estrogen receptor-HER2/neu cross-talk in ER/HER2-positive breast cancer. J Natl Cancer Inst. 2004;96(12):926-935. 4. De Laurentiis M, Arpino G, Massarelli G, et al. A meta-analysis on the interaction between HER-2 expression and response to endocrine treatment in advanced breast cancer. Clin Cancer Res. 2005;11(13):4741-4748. 5. Miller TW, Rexer BN, Garrett JT, Arteaga CL. Mutations in the phosphatidylinositol 3-kinase pathway: role in tumor progression and therapeutic implications in breast cancer. Breast Cancer Res. 2011;13(6):224. 6. AFINITOR [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2014.