AFINITOR®(everolimus) tablets

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Advanced Pancreatic Neuroendocrine Tumors

AFINITOR is indicated for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease. The safety and effectiveness of AFINITOR in the treatment of patients with carcinoid tumors have not been established.

Important Safety Information

There have been reports of non-infectious pneumonitis, infections and kidney failure (including acute renal failure) in patients taking AFINITOR, some with fatal outcomes. Oral ulceration is the most frequently occurring adverse event and occurs in approximately 70% of AFINITOR-treated patients, which were mostly Grade 1 or 2. Grade 3 or 4 stomatitis was reported in 6% of patients with neuroendocrine tumors. Elevations of serum creatinine, proteinuria, glucose, lipids, and triglycerides and reductions of hemoglobin, lymphocytes, neutrophils, and platelets have also been reported.

Please see additional Important Safety Information.

Full Prescribing Information

Get the full Prescribing Information for Afinitor in the treatment of advanced pancreatic neuroendocrine tumors (PNET).

How Afinitor Works

View the mechanism of action for Afinitor.

Important Safety Information

AFINITOR is contraindicated in patients with hypersensitivity to everolimus, to other rapamycin derivatives, or to any of the excipients.

Non-infectious Pneumonitis: Non-infectious pneumonitis was reported in 11-14% of patients treated with Afinitor. The incidence of Common Terminology Criteria (CTC) grade 3 and 4 non-infectious pneumonitis was 1.6%-4.0% and 0.1%, respectively. Fatal outcomes have been observed. If symptoms are moderate, patients should be managed with dose interruption until symptoms improve. If symptoms are severe, AFINITOR therapy should be discontinued. Under both circumstances, corticosteroids may be indicated and AFINITOR may be reintroduced at 5 mg daily, or approximately 50% lower than the dose previously administered, depending on the individual clinical circumstances. The development of pneumonitis has been reported even at a reduced dose.

Infections: AFINITOR has immunosuppressive properties and may predispose patients to localized or systemic bacterial, fungal, viral, or protozoal infections (including those with opportunistic pathogens). Viral infections may include reactivation of hepatitis B infection. Some of these infections have been severe (e.g., leading to respiratory or hepatic failure) or fatal. Physicians and patients should be aware of the increased risk of infection with Afinitor. Treatment of pre-existing invasive fungal infections should be completed prior to starting treatment. Be vigilant for signs and symptoms of infection and institute appropriate treatment promptly; interruption or discontinuation of AFINITOR should be considered. Discontinue AFINITOR if invasive systemic fungal infection is diagnosed and institute appropriate treatment.

Oral Ulceration: Oral ulcerations (i.e., mouth ulcers, stomatitis, and oral mucositis) are the most frequently occurring adverse event and occur in approximately 70% of advanced PNET patients, 44% of advanced RCC patients, and 86% of SEGA patients, which were mostly Grade 1 or 2. Grade 3 or 4 stomatitis was reported in 6% of patients with neuroendocrine tumors. In such cases, topical treatments are recommended, but alcohol- or peroxide-containing mouthwashes should be avoided. Antifungal agents should not be used unless fungal infection has been diagnosed.

Renal Failure: Cases of renal failure (including acute renal failure), some with a fatal outcome, have been observed in patients treated with AFINITOR.

Laboratory Tests and Monitoring: Elevations of serum creatinine, proteinuria, glucose, lipids, and triglycerides, and reductions of hemoglobin, lymphocytes, neutrophils, and platelets have been reported. Renal function, blood glucose, lipids, and hematologic parameters should be evaluated prior to treatment and periodically thereafter. When possible, optimal glucose and lipid control should be achieved before starting a patient on AFINITOR.

Drug-drug Interactions: Avoid co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole). Use caution and reduce the AFINITOR dose to 2.5 mg daily if co-administration with a moderate CYP3A4 and/or PgP inhibitor is required (e.g., amprenavir, fosamprenavir, aprepitant, erythromycin, fluconazole, verapamil, diltiazem). Avoid co-administration with strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital); however, if co-administration is required in advanced PNET or RCC patients, increase the AFINITOR dose from 10 mg daily up to 20 mg daily, using 5 mg increments. In SEGA patients, double the AFINITOR dose.

Hepatic Impairment: AFINITOR should not be used in patients with severe hepatic impairment. Exposure of everolimus was increased in patients with moderate hepatic impairment. In advanced PNET and RCC patients, the AFINITOR dose should be reduced to 5 mg daily for patients with moderate hepatic impairment. In SEGA patients, adjustment to the starting dose may not be needed; however, subsequent dosing should be individualized based on therapeutic drug monitoring.

Vaccinations: The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with AFINITOR. The timing of routine vaccinations in pediatric patients with SEGA should be considered prior to the start of AFINITOR therapy.

Use in Pregnancy: Fetal harm can occur if AFINITOR is administered to a pregnant woman. Women of childbearing potential should be advised to use an effective method of contraception while using AFINITOR and for up to 8 weeks after ending treatment.

Advanced PNET:

Adverse Reactions: The most common adverse reactions (incidence ≥ 30%) were stomatitis (70%), rash (59%), diarrhea (50%), fatigue (45%), edema (39%), abdominal pain (36%), nausea (32%), fever (31%), headache (30%), decreased appetite (30%). The most common grade 3/4 adverse reactions (incidence ≥ 5%) were stomatitis (7%) and diarrhea (5.5%). Deaths primarily due to adverse events during double-blind treatment phase occurred in 7 patients taking AFINITOR.

Laboratory Abnormalities: The most common laboratory abnormalities (incidence ≥ 50%, all grades) were: decreased hemoglobin (86%) and bicarbonate (56%); increased fasting glucose (75%), alkaline phosphatase (74%), cholesterol (66%) and aspartate transaminase, AST (56%). The most common grade 3/4 laboratory abnormalities (incidence ≥ 5%) were: decreased hemoglobin (15%), lymphocytes (16%) and phosphate (10%); increased glucose (17%) and alkaline phosphatase (8%).

Advanced RCC:

Adverse Reactions: The most common adverse reactions (incidence ≥30%) were stomatitis (44%), infections (37%), asthenia (33%), fatigue (31%), cough (30%), and diarrhea (30%). The most common grade 3/4 adverse reactions (incidence ≥5%) were infections (10%), dyspnea (7%), stomatitis (5%) and fatigue (5%). Deaths due to acute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were observed on the AFINITOR arm.

Laboratory Abnormalities: The most common laboratory abnormalities (incidence ≥ 50%, all grades) were: decreased hemoglobin (92%) and lymphocytes (51%); increased cholesterol (77%), triglycerides (73%), glucose (57%) and creatinine (50%). The most common grade 3/4 laboratory abnormalities (incidence ≥ 5%) were: decreased hemoglobin (13%), lymphocytes (18%), and phosphate (6%); and increased glucose (16%).

SEGA:

Adverse Reactions: The most common adverse reactions (incidence ≥30%, all grades) were stomatitis (86%), upper respiratory tract infection (82%), sinusitis (39%), otitis media (36%), and pyrexia (32%). The most common grade 3 adverse reactions (incidence ≥3%) were convulsion (7%), sinusitis (4%), pneumonia (4%), viral bronchitis (4%), tooth infection (4%), stomatitis (4%), aspiration (4%), cyclic neutropenia (4%), sleep apnea syndrome (4%), vomiting (4%), dizziness (4%), white blood cell count decreased (4%), and neutrophil count decreased (4%). A grade 4 convulsion (4%) was reported.

Laboratory Abnormalities: The most common laboratory abnormalities (incidence ≥50%, all grades) were elevations in aspartate transaminase (AST) concentrations (89%), total cholesterol (68%), and reductions in white blood cell counts (54%). Grade 3 laboratory abnormalities were elevated AST concentrations (4%) and low absolute neutrophil count (4%).

Please see full Prescribing Information for AFINITOR.

Indications

Advanced Neuroendocrine Tumors of Pancreatic Origin (PNET)

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Advanced Renal Cell Carcinoma (RCC)

AFINITOR is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.

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Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis (SEGA – TS)

AFINITOR is indicated for the treatment of patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS) who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of AFINITOR is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been demonstrated.

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AFN-1025612