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Printer friendlyNurses are central to the health and well-being of patients with advanced renal cell carcinoma
This Afinitor Nurse's Center is designed to provide relevant information as it relates to the care of patients with advanced renal cell carcinoma who are prescribed Afinitor (everolimus) tablets after failure of treatment with sunitinib or sorafenib. The practice of oncology nursing encompasses the roles of caregiver, educator, and consultant to patients. Managing the health and well-being of patients is an essential part of the care of patients with advanced renal cell carcinoma. Setting expectations about side effects, potential outcomes, and the importance of medication adherence remains critical for both patients and their caregivers.
Novartis Oncology understands that obtaining medications can sometimes be a challenge for your patients. To help streamline the insurance process for you and your patients, Novartis has developed the AfiniTRAC™ reimbursement support program. The program offers solutions and support across the entire reimbursement spectrum. Learn more about AfiniTRAC reimbursement support.
Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
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 is a class effect of rapamycin derivatives, including Afinitor. Fatal outcomes have been observed. If symptoms are moderate or severe, patients should be managed with dose interruption until symptoms improve or discontinuation, respectively. Corticosteroids may be indicated. Afinitor may be reintroduced at 5 mg daily depending on the individual clinical circumstances.
Afinitor has immunosuppressive properties and may predispose patients to infections. Localized and systemic infections (bacterial and invasive fungal infections) have occurred. Some of these infections have been severe or fatal. Complete treatment of pre-existing invasive fungal infections prior to starting treatment. If a diagnosis of invasive systemic fungal infection is made, discontinue Afinitor and treat with appropriate antifungal therapy.
Oral ulcerations have occurred in patients treated with Afinitor. 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.
Elevations of serum creatinine, glucose, lipids, and triglycerides and reductions of hemoglobin, lymphocytes, neutrophils and platelets have been reported in clinical trials. Renal function, hematological parameters, blood glucose, and lipids 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.
Co-administration with strong or moderate inhibitors of CYP3A4 or PgP should be avoided. Increase in the Afinitor dose is recommended when co-administered with a strong CYP3A4 inducer.
Afinitor should not be used in patients with severe hepatic impairment.
The use of live vaccines and close contact with those who have received live vaccines should be avoided during treatment with Afinitor.
Fetal harm can occur if Afinitor is administered to a pregnant woman.
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 ≥3%) were infections (9%), dyspnea (8%), fatigue (5%), stomatitis (4%), dehydration (4%), pneumonitis (4%), abdominal pain (3%), and asthenia (3%). The most common laboratory abnormalities (incidence ≥50%) were anemia (92%), hypercholesterolemia (77%), hypertriglyceridemia (73%), hyperglycemia (57%), lymphopenia (51%), and increased creatinine (50%). The most common grade 3/4 laboratory abnormalities (incidence ≥3%) were lymphopenia (18%), hyperglycemia (16%), anemia (13%), hypophosphatemia (6%), and hypercholesterolemia (4%). Deaths due to acute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were observed on the Afinitor arm.
Full Prescribing Information about Afinitor.
