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Data to be Presented at ASCO 2007 Highlights sanofi-aventis,Commitment to Cancer Care and Research

as evidenced in the adjuvant study by increase in transaminases and alkaline phosphatase was observed more commonly in the Eloxatin(R) combination arm. The incidence of increased bilirubin was similar on both arms. Changes noted on liver biopsies include: peliosis, nodular regenerative hyperplasia or sinusoidal alterations, perisinusoidal fibrosis and veno-occlusive lesions. Hepatic vascular disorders should be considered and, if appropriate, investigated in case of abnormal liver function test results or portal hypertension not explained by liver metastases -- Monitoring of white blood cell count with differential, hemoglobin, platelet count and blood chemistries (including ALT, AST, bilirubin and creatinine) is recommended before each Eloxatin(R) cycle -- The safety and effectiveness of Eloxatin(R) plus 5-FU/LV in patients with renal impairment have not been evaluated. Since the primary route of platinum elimination is renal, this combination should be used with caution in patients with preexisting renal impairment. Clearance of these products may be decreased by coadministration of potentially nephrotoxic compounds, although this has not been specifically studied -- The incidence of diarrhea, dehydration, hypokalemia, leukopenia, fatigue and syncope were higher in patients greater than or equal to 65 years old -- Extravasation may result in local pain and inflammation that may be severe and lead to complications, including necrosis. Injection site reaction, including redness, swelling and pain, has been reported -- There have been reports of prolonged prothrombin time and INR occasionally associated with hemorrhage in patients receiving Eloxatin(R) plus 5-FU/LV while on anticoagulants. Patients receiving Eloxatin(R) plus 5-FU/LV and requiring oral anticoagulant
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