AFINITOR- everolimus tablet
AFINITOR DISPERZ- everolimus tablet, for suspension
Novartis Pharmaceuticals Corporation
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use AFINITOR safely and effectively. See full prescribing information for AFINITOR.
AFINITOR® (everolimus) tablets for oral administration
AFINITOR® DISPERZ (everolimus tablets for oral suspension)
Initial U.S. Approval: 2009
RECENT MAJOR CHANGES
Dosage and Administration (2.2, 2.3, 2.5, 2.6, 2.7) 2/2014
Warnings and Precautions, Non-infectious Pneumonitis (5.1) 7/2014
Warnings and Precautions, Infections (5.2) 7/2014
Warnings and Precautions, Angioedema (5.3) 1/2015
Warnings and Precautions, Oral Ulceration (5.4) 2/2014
Warnings and Precautions, Impaired Wound Healing (5.6) 2/2014
Warnings and Precautions, Lab Tests and Monitoring (5.8) 2/2014
Warnings and Precautions, Embryo-fetal Toxicity (5.12) 2/2014
INDICATIONS AND USAGE
AFINITOR is a kinase inhibitor 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. (1.1)
•adults with progressive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. (1.2)
•adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. (1.3)
•adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. The effectiveness of AFINITOR in the treatment of renal angiomyolipoma is based on an analysis of durable objective responses in patients treated for a median of 8.3 months. Further follow-up of patients is required to determine long-term outcomes. (1.4)
AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of:
•pediatric and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. The effectiveness is based on demonstration of durable objective response, as evidenced by reduction in SEGA tumor volume. Improvement in disease-related symptoms and overall survival in patients with SEGA and TSC has not been demonstrated. (1.5)
DOSAGE AND ADMINISTRATION
Advanced HR+ BC, advanced PNET, advanced RCC, or renal angiomyolipoma with TSC:
•10 mg once daily with or without food. (2.1)
•For patients with hepatic impairment, reduce the AFINITOR dose. (2.2)
•If moderate inhibitors of CYP3A4 /P-glycoprotein (PgP) are required, reduce the AFINITOR dose to 2.5 mg once daily; if tolerated, consider increasing to 5 mg once daily. (2.2)
•If strong inducers of CYP3A4 are required, consider doubling the daily dose of AFINITOR using incre
