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Printer friendlyAfinitor is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
Please see Important Safety Information below
When should your patients start therapy with Afinitor®?1
According to National Comprehensive Cancer Network (NCCN) guidelines, Afinitor is the first and only category 1 treatment option after VEGFR tyrosine kinase inhibitor (TKI) failure. Consider easing your patients' transition after VEGFR-TKI failure. Start them on the only daily oral therapy approved as a second line therapy after sunitinib or sorafenib failure in advanced renal cell carcinoma.
What kind of response could your patients expect with Afinitor?2-4
Clinical trials have shown that people receiving Afinitor as a second-line therapy after sunitinib or sorafenib failure in advanced renal cell carcinoma have experienced a clear therapeutic benefit. While results may vary, on average, people of all MSKCC* risk types treated with Afinitor were more likely to reduce the risk of progression. Learn more about the clinical trial design.
Afinitor can cause lung and breathing problems as well as make the patient more likely to have an infection. Patients should contact their physician immediately if they experience new or worsening cough, shortness of breath, difficulty breathing, or wheezing, have a fever of 100.5 or above, chills, or does not feel well. Dosage of Afinitor may need to be lowered or stopped for awhile. In clinical trials, some patients treated with Afinitor had serious side effects. Learn ways to help manage side effects.
How is Afinitor thought to work?2
Afinitor is a signal transduction inhibitor targeting mTOR (mammalian target of rapamycin). This means that Afinitor works by directly inhibiting mTOR. This has been shown to result in reduced tumor cell growth and proliferation, reduced cell metabolism, and reduced tumor angiogenesis. See how Afinitor works.
How long should your patients be on therapy with Afinitor?
Patients should remain on Afinitor for as long as their doctor recommends continuing treatment. Afinitor should most likely be continued until a doctor determines that the cancer has grown larger or spread, or until the risks of taking Afinitor outweigh the benefits. Find more information on recommended dosing and administration.
What is the recommended dose of Afinitor?
The recommended dose of Afinitor for treatment of advanced renal cell carcinoma is 10 mg, to be taken once daily at the same time every day, either with or without food. Afinitor tablets should be swallowed whole with a glass of water. No premedication is required, and no dose adjustments are necessary for age, gender, body weight, or renal function.
Management of severe and/or intolerable adverse reactions may require temporary dose reduction and/or interruption of Afinitor therapy. If dose reduction is required, the suggested dose is 5 mg daily. Find more information on recommended dosing and administration.
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.
References
- National Comprehensive Cancer Network. Clinical Practice Guidelines in Oncology. Kidney Cancer. V.1.2010. http://www.nccn.org/professionals/physician_gls/PDF/kidney.pdf. Accessed September 30, 2009.
- Afinitor [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2009.
- Data on File. Study No. CRAD001C2240. February 2007. Novartis.
- Escudier B, Ravaud A, Oudard S, et al. Phase III randomized trial of everolimus (RAD 001) vs placebo in metastatic renal cell carcinoma. Ann Oncol. 19 (Supplement 8):2008:viii44-viii46.
