inical Study Experience in Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
6.2 Clinical Study Experience in Advanced Pancreatic Neuroendocrine Tumors 6.3 Clinical Study Experience in Advanced Renal Cell Carcinoma
6.4 Clinical Study Experience in Renal Angiomyolipoma with Tuberous Sclerosis Complex
6.5 Clinical Study Experience in Subependymal Giant Cell Astrocytoma with Tuberous Sclerosis Complex
6.6 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Agents That May Increase Everolimus Blood Concentrations
7.2 Agents That May Decrease Everolimus Blood Concentrations
7.3 Drugs That May Have Their Plasma Concentrations Altered by Everolimus
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Females and Males of Reproductive Potential
8.7 Renal Impairment
8.8 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.6 QT/QTc Prolongation Potential
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
14.2 Advanced Neuroendocrine Tumors
14.3 Advanced Renal Cell Carcinoma
14.4 Renal Angiomyolipoma with Tuberous Sclerosis Complex
14.5 Subependymal Giant Cell Astrocytoma with Tuberous Sclerosis Complex
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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Sections or subsections omitted from the full prescribing information are not listed.
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC)
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.
1.2 Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET)
AFINITOR® is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, local |
