1. AGENCY: GSW CREATIVE TEAM: Kelly Seymour, Katie Beller, Ben Denton, Gino Valii, Dave Sonderman CLIENT: Astellas Pharma 2. AGENCY: Euro RSCG Life Chelsea CREATIVE TEAM: Amadeu Dimas, Caroline Feraldo, Malcolm Hall CLIENT: Roche / 'MS. ' H V / i —"1a/ a! adjuvant treatm ent of Dukes1C (stage III) colon cancer* * XELODA’ (capecitabine) is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with ftuoropyrimidine therapy alone is preferred. XELODA was non-inferior to 5-fluorouracil and leucovorin (5-FU/lV) for disease-free survival (DFS). Although neither XELODA nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-FU/LV. Physicians should consider these results when prescribing single-agent XELODA in the adjuvant treatment of Dukes' C colon cancer. XELODA is contraindicated in patients with sovore renal impairment. Patients with mild or moderate renal impairment at baseline should be carefully monitored for adverse events. XELODA can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. It an adverse event of grade 2.3, or 4 occurs (eg. diarrhea), administration of XELODA should be immediately interrupted until the adverse event resolves or decreases in intensity to grade 1. Following a grade 2 reoccurrence of the adverse event or occurrence ot any other grade 3 or 4 adverse event, subsequent doses of XELODA should be decreased. Please consult XELODA Prescribing Information (DOSAGE ANO ADMINISTRATION) for recommended dose modifications for management of adverse events. Women of childbearing potential should be advised to avoid becoming pregnant white receiving treatment with XELODA. Men should use birth control while taking XELODA. Women should not nurse 'when receiving XELODA therapy. Adverse reactions: in XELODA monotherapy for colon cancer in the adjuvant setting, the most common adverse events (>10%) In patients receiving either XELODA or 5-FU/LV (%;%) -were hand-foot syndrome (60:9). diarrhea (47,65). nausea (34:47). stomatitis (22;60), fatigue (!6;15). vomiting (15:21). abdominal pain (14:16). asthenia (10;10). lethargy (10.9), anorexia (9:11), constipation (9;11), and alopecia (6;22). Grade 3/4 adverse events (>5%) in patients receiving either XELODA or 5-FU/lV were hand-foot syndrome (17;<1). diarrhea (12;14), stomatitis (2:14). and neutropenia (<1;5> Please see summary of XELODA prescribing information on adjacent pages, including boxed WARNING. WARNING: For patients receiving XELODA and warfarin concomitantly, frequent monitoring of INR or prothrombin time (PT) is recommended. A clinically important drug interaction between XELODA and warfarin has been demonstrated. Altered coagulation parameters and/or bleeding and death have been reported. CJmicaHy significant increases in PT and INR have been observed within days to months after starting XELODA. and infrequently within one month of stopping XELODA. These events occurred in patients with and without liver metastases. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy. Contraindications and Warnings: XELODA is contraindicated in patients who have a known hypersensitivity to capecitabine or to any ot its components or to 5-ftuorouracil. XELODA is contraindicated in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Rochet Pharm aceuticals 197
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