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New 200 mg Vial for Eloxatin(R) (Oxaliplatin Injection) Offers Greater Convenience and Efficiency of Preparation
Date:8/27/2007

known whether

Eloxatin(R) or its derivatives are excreted in human milk

-- Eloxatin(R) has been associated with pulmonary fibrosis (<1% of study

patients), which may be fatal. The combined incidence of cough and

dyspnea was 7.4% (<1% grade 3, no grade 4) in the Eloxatin(R) plus 5-

FU/LV arm compared to 4.5% (no grade 3, 0.1% grade 4) in the 5-FU/LV

alone arm in the adjuvant colon cancer study. In this study, one

patient died from eosinophilic pneumonia in the Eloxatin(R) combination

arm. The combined incidence of cough, dyspnea, and hypoxia was 43% (7%

grade 3 and 4) in the Eloxatin(R) plus 5-FU/LV arm compared to 32% (5%

grade 3 and 4) in the irinotecan plus 5-FU/LV arm in patients with

previously untreated colorectal cancer. In case of unexplained

respiratory symptoms, Eloxatin(R) should be discontinued until

pulmonary investigation excludes interstitial lung disease or pulmonary

fibrosis

-- Eloxatin(R) is associated with two types of primarily peripheral

sensory neuropathy: an acute, reversible type of early onset and a

persistent type (>14 days). In patients with advanced colorectal cancer

paresthesias occurred in 77% (all grades) and 18% (grade 3/4) of

previously untreated patients. In previously treated patients, acute

neuropathy occurred in 56% (all grades) and 2% (grade 3/4) of patients;

persistent neuropathy occurred in 48% (all grades) and 6% (grade 3/4)

of patients. In patients with stage II and III colon cancer,

paresthesia was seen in 92% (all grades) and 13% (grade 3/4) of

patients; 21% (all grades), 0.5% (grade 3/4) had residual paresthesia

at 18-month follow-up

-- Hepatotoxicity, as evidenced in the adjuvant study by increase in

transaminases and alkaline phosphatase was observed more commonly in

the Eloxatin(R)
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SOURCE sanofi-aventis
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