Target Audience Learning Objectives
Program Chair & Faculty: Trish Creel, RN, BSN, OCN®, CCRP Program Outline:
This program was developed by Novartis Oncology. ONSEdge, Inc., has been assigned meeting space to provide an ancillary event funded by Novartis Oncology during the Oncology Nursing Society's (ONS) 34th Annual Congress. The Oncology Nursing Society's assignment of meeting space does not imply product endorsement, nor does the Oncology Nursing Society assume any responsibility for the educational content. RSVP Deadline: Monday, April 20, 2009 – 5:00 pm ET For more information please call 877-588-3343, 412-859-6108, or email ONSEdgeRSVP@ons.org. Note: By providing your e-mail and fax, you are granting permission to ONSEdge and Novartis Oncology to communicate with you via fax and e-mail. ONSEdge and Novartis Oncology will not share e-mail or fax information with any other outside entities. NO continuing nursing education (CNE) contact hours will be awarded. In order to register for this event you must acknowledge (by checking the box) that this program does NOT offer continuing nursing education. 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, infections, asthenia, fatigue, cough, and diarrhea. The most common grade 3/4 adverse reactions (incidence ≥3%) were infections, dyspnea, fatigue, stomatitis, dehydration, pneumonitis, abdominal pain, and asthenia. The most common laboratory abnormalities (incidence ≥50%) were anemia, hypercholesterolemia, hypertriglyceridemia, hyperglycemia, lymphopenia, and increased creatinine. The most common grade 3/4 laboratory abnormalities (incidence ≥3%) were lymphopenia, hyperglycemia, anemia, hypophosphatemia, and hypercholesterolemia. Deaths due to acute respiratory failure (0.7%), infection (0.7%), and acute renal failure (0.4%) were observed on the Afinitor arm. Please see full Prescribing Information at www.AFINITOR.com
East Hanover, NJ 07369 |
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