s: Avoid concomitant use. (2.2, 2.5, 5.9, 7.1)
•Moderate CYP3A4/PgP inhibitors: If combination is required, use caution and reduce dose of AFINITOR. (2.2, 2.3, 2.5, 5.9, 7.1)
•Strong CYP3A4/PgP inducers: Avoid concomitant use. If combination cannot be avoided, increase dose of AFINITOR. (2.2, 2.3, 2.5, 5.9, 7.2)
USE IN SPECIFIC POPULATIONS
•Nursing mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. (8.3)
•Hepatic impairment: For advanced HR+ BC, advanced PNET, advanced RCC, or renal angiomyolipoma with TSC patients with hepatic impairment, reduce AFINITOR dose. For SEGA patients with severe hepatic impairment, reduce the starting dose of AFINITOR Tablets or AFINITOR DISPERZ. (2.2, 2.3, 2.5, 5.10, 8.8)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 1/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer (Advanced HR+ BC)
1.2 Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET)
1.3 Advanced Renal Cell Carcinoma (RCC)
1.4 Renal Angiomyolipoma with Tuberous Sclerosis Complex (TSC)
1.5 Subependymal Giant Cell Astrocytoma (SEGA) with Tuberous Sclerosis Complex (TSC)
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose in Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced PNET, Advanced RCC, and Renal Angiomyolipoma with TSC
2.2 Dose Modifications in Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer, Advanced PNET, Advanced RCC, and Renal Angiomyolipoma with TSC
2.3 Recommended Dose in SEGA with TSC
2.4 Therapeutic Drug Monitoring in SEGA with TSC
2.5 Dose Modifications in SEGA with TSC
2.6 Administration of AFINITOR Tablets in SEGA with TSC
2.7 Administration and Preparation of AFINITOR DISPERZ in SEGA with TSC
3 DOSAGE FORMS AND STRENGTHS
3.1 AFINITOR (everolimus) Tablets
3.2 AFINITOR DISPERZ (everolimus tablets for oral suspension)
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Non-infectious Pneumonitis
5.2 Infections
5.3 Angioedema with Concomitant Use of Angiotensin-Converting Enzyme (ACE) Inhibitors
5.4 Oral Ulceration
5.5 Renal Failure
5.6 Impaired Wound Healing
5.7 Geriatric Patients
5.8 Laboratory Tests and Monitoring
5.9 Drug-drug Interactions
5.10 Hepatic Impairment
5.11 Vaccinations
5.12 Embryo-fetal Toxicity
6 ADVERSE REACTIONS
6.1 Cl |
