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Afinitor/Afinitor Disperz
Generic Name: Everolimus
Drug Category: Kinase Inhibitor
Litigation Alert Level: Low
This drug has been approved for use by males and females over the age of 1 year old for a maximum duration of 7 years.
| Approved Uses |
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Indicated for: Hormone Receptor-Positive, HER2-Negative Breast Cancer: • AFINITOR is 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. Neuroendocrine Tumors (NET): • AFINITOR is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. • AFINITOR is indicated for the treatment of adult patients with progressive, well-differentiated, non-functional NET of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. Renal Cell Carcinoma (RCC): • AFINITOR is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma: • AFINITOR is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery. Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA): • AFINITOR and AFINITOR DISPERZ are indicated for adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected. Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures: • AFINITOR DISPERZ is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. The safety and effectiveness of AFINITOR Tablets and AFINITOR DISPERZ have not been established in pediatric patients with renal angiomyolipoma with TSC in the absence of SEGA. AFINITOR and AFINITOR DISPERZ are two different dosage forms. Select the recommended dosage form based on the indication. Do not combine AFINITOR and AFINITOR DISPERZ to achieve the total dose. 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. The effectiveness of AFINITOR in the treatment of tuberous sclerosis complex (TSC) with subependymal giant cell astrocytoma (SEGA) 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. During AFINITOR treatment, avoid the use of live vaccines and avoid close contact with individuals who have received live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines). For pediatric patients with SEGA that do not require immediate treatment, complete the recommended childhood series of live virus vaccinations according to American Council on Immunization Practices (ACIP) guidelines prior to the start of therapy. An accelerated vaccination schedule may be appropriate. The safety and effectiveness of AFINITOR in patients with locally advanced or metastatic functional carcinoid tumors have not been demonstrated. Monitor everolimus whole blood trough levels routinely in all patients. When possible, use the same assay and laboratory for therapeutic drug monitoring throughout treatment. Hyperglycemia, hypercholesterolemia, and hypertriglyceridemia have been reported in patients taking AFINITOR/AFINITOR DISPERZ. Anemia, lymphopenia, neutropenia, and thrombocytopenia have been reported in patients taking AFINITOR/AFINITOR DISPERZ. Patients taking concomitant ACE inhibitor therapy may be at increased risk for angioedema. Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with AFINITOR. Stomatitis, including mouth ulcers and oral mucositis most often occurs within the first 8 weeks of treatment. Radiation sensitization and recall, in some cases severe, involving cutaneous and visceral organs (including radiation esophagitis and pneumonitis) have been reported in patients treated with radiation prior to, during, or subsequent to AFINITOR/AFINITOR DISPERZ treatment. Consider a diagnosis of non-infectious pneumonitis in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, pleural effusion, cough, or dyspnea, and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. Everolimus delays wound healing and increases the occurrence of wound-related complications like wound dehiscence, wound infection, incisional hernia, lymphocele, and seroma. These wound-related complications may require surgical intervention. Exercise caution with the use of AFINITOR in the peri-surgical period. AFINITOR has immunosuppressive properties and may predispose patients to fungal, viral, or protozoal infections, including infections with opportunistic pathogens. Localized and systemic infections, including pneumonia, mycobacterial infections, other bacterial infections, invasive fungal infections, such as aspergillosis, candidiasis, or pneumocystis jiroveci pneumonia (PJP) and viral infections including reactivation of hepatitis B virus have occurred in patients taking AFINITOR. Some of these infections have been severe (e.g., leading to sepsis, respiratory or hepatic failure) or fatal. Patients taking concomitant ACE inhibitors with AFINITOR/AFINITOR DISPERZ may be at increased risk for angioedema (e.g., swelling of the airways or tongue, with or without respiratory impairment). Permanently discontinue AFINITOR/AFINITOR DISPERZ for Grade 4:
Grapefruit, grapefruit juice, and other foods that are known to inhibit cytochrome P450 and PgP activity may increase everolimus exposures and should be avoided during treatment. Avoid the use of concomitant strong CYP3A4/PgP inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital). St. John’s Wort (Hypericum perforatum) may decrease everolimus exposure unpredictably and should be avoided. Avoid the use of concomitant strong CYP3A4/PgP inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) in patients receiving AFINITOR Tablets or AFINITOR DISPERZ. Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with AFINITOR and for 8 weeks after final dose. |
| Off-label Uses |
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• The use in patients under the age of 1 year. GoToSource • Locally advanced or metastatic functional carcinoid tumors. GoToSource • Rheumatoid arthritis. GoToSource • Immunosuppression after solid organ transplantation. GoToSource • Metastatic renal cell carcinoma after failure of bevacizumab. GoToSource • Lymphoma and gastric cancer. GoToSource |
| Adverse Events |
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Stomatitis (inflammation inside of mouth), mouth ulcerations, pyrexia (fever) and pneumonia. GoToSource Upper respiratory infections, sinusitis, otitis media (inflammation of the middle ear) and convulsions. GoToSource Acne-like skin lesions and secondary amenorrhea (absence of menstruation). GoToSource Gastroenteritis (inflammation of stomach and intestines). GoToSource Opportunistic infections (pneumocystis and jiroveci pneumonia). GoToSource Cholecystitis (inflammation of gallbladder). GoToSource Asthenia (lack of energy and strength) and thrombocytopenia (low blood platelet count ). GoToSource Cholelithiasis (gallstones). GoToSource Impaired wound healing. GoToSource Gonadal dysfunction, ovarian toxicity, kidney injury and lymphedema (localized swelling). GoToSource Fetal harm. GoToSource Angioedema (swelling in deep layers of skin). GoToSource Lung toxicity. GoToSource Hyperlipidemia (elevated lipids or fats in the blood). GoToSource Anemia (low red blood count). GoToSource leukopenia (low white blood cell count ) and lymphopenia (reduce number of lymphocytes, a type of white blood cell). GoToSource Hyperuricemia (high level of uric acid in blood), neutropenia ( low level of neutrophils, a type of white blood cell), hypercholesterolaemia (high blood cholesterol), hypophosphatemia (low blood phosphate level), hyperglycemia (high blood sugar) and proteinuria (excess protein in urine). GoToSource Hepatic steatosis (accumulation of fat in the liver), pleural (fluid around the lung ) or pericardial effusions (fluid around the heart), elevated transaminases (indicating inflammation or damage to liver cells), electrolyte disorders, edema (swelling) and hypertension (high blood sugar). GoToSource Interstitial pneumonia (lung disorder causing scarring of the lungs). GoToSource Heart failure. GoToSource |
| Litigation |
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No major injury lawsuits reported. |
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