Afinitor 10 mg/1
everolimus · TABLET · Novartis Pharmaceuticals Corporation
Afinitor is a tablet containing everolimus at 10 mg/1, taken oral. Manufactured by Novartis Pharmaceuticals Corporation.
Key Facts
- Brand Name
- Afinitor
- Generic Name
- everolimus
- NDC Code (Product)
0078-0567- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 10 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA022334
- Drug Class
- Kinase Inhibitor [EPC]; mTOR Inhibitor Immunosuppressant [EPC]
- Marketing Start
- 03/31/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE AFINITOR is a kinase inhibitor 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. ( 1.1 ) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: 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. ( 1.4 ) AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) AFINITOR DISPERZ is a kinase inhibitor indica…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total daily dose. ( 2.1 ) Breast Cancer : 10 mg orally once daily. ( 2.2 ) NET : 10 mg orally once daily. ( 2.3 ) RCC : 10 mg orally once daily. ( 2.4 ) TSC-Associated Renal Angiomyolipoma : 10 mg orally once daily. ( 2.5 ) TSC-Associated SEGA : 4.5 mg/m 2 orally once daily; adjust dose to attain trough concentrations of 5-15 ng/mL. ( 2.6 , 2.8 ) TSC-Associated Partial-Onset Seizures : 5 mg/m 2 orally once daily; adjust dose to attain trough concentrations of 5-15 ng/mL. ( 2.7 , 2.8 ) 2.1 Important Dosage Information AFINITOR and AFINITOR DISPERZ are two different dosage forms. Select the recommended dosage form based on the indication [see Indications and Usage (1)] . Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total dose. 2.2 Recommended Dosage for Hormone Receptor-Positive, HER2-Negative Breast Cancer The recommended dosage of AFINITOR is 10 mg orally once daily until disease progression or unacceptable toxicity. 2.3 Recommended Dosage for Neuroendocrine Tumors (NET) The recommended dosage of AFINITOR is 10 mg orally once daily until disease progression or unacceptable toxicit…
Contraindications
4 CONTRAINDICATIONS AFINITOR/AFINITOR DISPERZ is contraindicated in patients with clinically significant hypersensitivity to everolimus or to other rapamycin derivatives [see Warnings and Precautions (5.3)] . Clinically significant hypersensitivity to everolimus or to other rapamycin derivatives. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Strong CYP3A inhibitor and P-gp inhibitor : Avoid coadministration. ( 2.11 , 7.1 ) Moderate CYP3A inhibitor and P-gp inhibitor : Reduce the dosage as recommended. ( 2.11 , 7.1 ) Cannabidiol oral solution : Reduce the dosage as recommended. ( 2.11 , 7.1 ) Strong CYP3A inducer and P-gp inducer : Increase the dosage as recommended. ( 2.11 , 7.1 ) 7.1 Effect of Other Drugs on AFINITOR/AFINITOR DISPERZ Strong or Moderate CYP3A Inhibitor and P-gp Inhibitor Avoid the coadministration of a strong CYP3A inhibitor and P-gp inhibitor [see Dosage and Administration (2.11), Clinical Pharmacology (12.3)] . Reduce the dosage for AFINITOR/AFINITOR DISPERZ with a moderate CYP3A inhibitor and Pg-p inhibitor as recommended [see Dosage and Administration (2.11), Clinical Pharmacology (12.3)] . Cannabidiol Oral Solution Reduce the dosage of AFINITOR/AFINITOR DISPERZ when coadministered with cannabidiol oral solution [see Dosage and Administration (2.11)] . Coadministration with cannabidiol oral solution increases everolimus exposure [see Clinical Pharmacology (12.3)] , which may increase the risk of everolimus adverse reactions. The effects of other cannabidiol products on everolimu…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Non-Infectious Pneumonitis [see Warnings and Precautions (5.1)] Infections [see Warnings and Precautions (5.2)] Severe Hypersensitivity Reactions [see Warnings and Precautions (5.3)] Angioedema with Concomitant Use of ACE inhibitors [see Warnings and Precautions (5.4)] Stomatitis [see Warnings and Precautions (5.5)] Renal Failure [see Warnings and Precautions (5.6)] Impaired Wound Healing [see Warnings and Precautions (5.7)] Metabolic Disorders [see Warnings and Precautions (5.9)] Myelosuppression [see Warnings and Precautions (5.10)] Radiation Sensitization and Radiation Recall [see Warnings and Precautions (5.12)] Breast cancer, NET, RCC : Most common adverse reactions (incidence ≥ 30%) include stomatitis, infections, rash, fatigue, diarrhea, edema, abdominal pain, nausea, fever, asthenia, cough, headache, and decreased appetite. ( 6.1 ) TSC-Associated Renal Angiomyolipoma : Most common adverse reaction (incidence ≥ 30%) is stomatitis. ( 6.1 ) TSC-Associated SEGA : Most common adverse reactions (incidence ≥ 30%) are stomatitis and respiratory tract infection. ( 6.1 ) TSC-Associate…
Frequently Asked Questions
What is Afinitor used for?
Afinitor contains everolimus. It is a tablet taken oral. Consult your doctor for specific uses.
Is Afinitor a controlled substance?
Afinitor is not classified as a controlled substance by the DEA.
What is the generic name for Afinitor?
The generic name for Afinitor is everolimus. There are 11 other brand versions of everolimus.
What is the NDC code for Afinitor 10 mg/1?
The NDC (National Drug Code) for Afinitor 10 mg/1 is 0078-0567, listed by Novartis Pharmaceuticals Corporation.