Everolimus (everolimus)
Novartis (brands: Afinitor, Zortress); generics available · mTOR Inhibitor
What is Everolimus? Everolimus (brand: Afinitor) is an mTOR inhibitor by Novartis with multiple FDA-approved oncology indications including advanced renal cell carcinoma, HR+/HER2- advanced breast cancer (with exemestane), pancreatic neuroendocrine tumors, and progressive neuroendocrine tumors of GI or lung origin.
About Everolimus
| Brand Name | Everolimus |
| Generic / INN | everolimus |
| Drug Class | mTOR Inhibitor |
| Manufacturer | Novartis (brands: Afinitor, Zortress); generics available |
| Administration | Oral tablet |
| FDA Approval | 2009 |
FDA-Approved Uses for Everolimus
Indications are based on FDA approval. Your healthcare provider determines appropriate use based on your specific diagnosis, stage, biomarker status, and overall clinical picture.
- Advanced renal cell carcinoma (RCC) — after failure of sunitinib or sorafenib
- HR+/HER2-negative advanced breast cancer — with exemestane after failure of non-steroidal aromatase inhibitors
- Progressive well-differentiated, non-functional neuroendocrine tumors (NETs) — pancreatic (pNET), GI, or lung
- Renal angiomyolipoma with tuberous sclerosis complex (TSC)
- Subependymal giant cell astrocytoma (SEGA) with TSC
How Does Everolimus Work?
Everolimus inhibits the mTOR (mechanistic target of rapamycin) complex 1 (mTORC1), a key kinase that regulates cell growth, proliferation, and angiogenesis. In cancer cells, mTORC1 is often hyperactivated (via PI3K/AKT pathway mutations). Everolimus blocks this signaling, reducing tumor cell proliferation and VEGF-driven angiogenesis.
Dosage & Administration
Oncology: 10 mg orally once daily, taken consistently with or without food. Dose reductions to 5 mg or temporary interruption for toxicity (most commonly stomatitis, infections, metabolic effects). Avoid strong CYP3A4 and P-gp inhibitors/inducers.
Dosing is individualized by the prescribing clinician. Never adjust your dose without consulting your healthcare provider. This information is educational only and does not replace the official prescribing information.
Warnings, Precautions & Side Effects
General Warning
Non-infectious pneumonitis — can be severe; monitor with CT. Stomatitis — very common; use alcohol-free mouthwash prophylactically. Infections — immunosuppressive effect. Metabolic effects (hyperglycemia, hyperlipidemia, hypercholesterolemia). Nephrotoxicity. Wound healing impairment. Embryo-fetal toxicity.
- Non-infectious pneumonitis
- Severe infections (PCP, aspergillosis)
- Metabolic disorders (diabetes, hyperlipidemia)
- Renal failure
- Embryo-fetal toxicity
Common Side Effects
- Stomatitis/mouth sores (very common)
- Infections
- Fatigue
- Diarrhea
- Edema
- Hyperglycemia
- Hypercholesterolemia
- Rash
- Pneumonitis
This is not a complete list. Always report new or worsening symptoms to your healthcare provider promptly.
Storage & Handling
Store at 25°C (77°F). Protect from light and moisture. Keep in original packaging.
BiologicHealthPlus provides temperature-monitored cold-chain specialty delivery for medications requiring refrigeration. Never use a medication if its storage conditions have been compromised.
Insurance Coverage, Prior Authorization & Patient Assistance
🛡️ Commercial Insurance
Everolimus is covered by most major commercial insurance plans when medically necessary and prior authorized. Coverage tier and cost-sharing vary by plan.
✅ Prior Authorization
Prior authorization is required by virtually all insurance plans for Everolimus. BiologicHealthPlus handles the complete prior authorization process at no cost to patients or providers.
🏥 Medicare Coverage
Medicare Part D covers this oral specialty medication. Medicaid coverage varies by state.
🆓 Patient Assistance
Manufacturer patient assistance programs may be available for eligible uninsured or underinsured patients. Contact BiologicHealthPlus for a confidential eligibility review.
Prior Authorization Patient Assistance Insurance & Savings Medication Costs
Frequently Asked Questions — Everolimus
Everolimus is an mTOR inhibitor approved for advanced renal cell carcinoma, HR+/HER2- breast cancer (with exemestane), pancreatic and GI/lung neuroendocrine tumors, and TSC-related tumors.
Stomatitis (mouth sores) is the most common side effect of everolimus. Using an alcohol-free corticosteroid mouthwash (e.g., dexamethasone oral rinse) from the start of treatment significantly reduces severity and duration.
Yes. Generic everolimus 10 mg tablets are available from multiple manufacturers. The original brand is Afinitor (Novartis).
Everolimus is covered by most commercial insurance and Medicare Part D with prior authorization for approved indications.
Related Medications & Conditions
Related Medications
Verzenio (abemaciclib) · Exemestane · Sutent (sunitinib) · Lutathera (for NETs)
Related Conditions
Renal cell carcinoma (RCC) · HR+/HER2- breast cancer · Pancreatic neuroendocrine tumors (pNET) · Tuberous sclerosis complex (TSC)