There have been reports of noninfectious pneumonitis (including some with pulmonary hypertension as a secondary event), infections, and renal failure (including acute renal failure) in patients...
AFINITOR provides once-daily dosing
The recommended starting dose of AFINITOR® (everolimus) Tablets in advanced HR+, HER2-negative breast cancer is 10 mg once daily, regardless of age, gender, or renal function.1
Storage and handling1
Dosage modifications for P-gp and CYP3A4 inhibitors1
|Recommended dosage modifications for concurrent use of AFINITOR with a P-gp and moderate CYP3A4 inhibitor|
Dosage modifications for P-gp and CYP3A4 inducers1
|Recommended dosage modifications for concurrent use of AFINITOR with P-gp and strong CYP3A4 inducers|
AFINITOR offers the flexibility of 4 dosing strengths:
10-mg, 7.5-mg, 5-mg, and 2.5-mg tablets
|Degree of Impairment||Dose Adjustment|
|Mild (Child-Pugh class A)||
|Moderate (Child-Pugh class B)||
|Severe (Child-Pugh class C)||
HER2, human epidermal growth factor receptor 2; HR+, hormone receptor-positive; PgP, P-glycoprotein.
Reference: 1. Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018. 2. Exemestane [prescribing information]. New York, NY: Pfizer Inc.; 2016.
AFINITOR is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
Important Safety Information
AFINITOR is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives.
Severe Hypersensitivity Reactions
Angioedema With Concomitant Use of Angiotensin-Converting Enzyme (ACE) Inhibitors
Impaired Wound Healing
Risk of Infection or Reduced Immune Response With Vaccinations
Please see full Prescribing Information.