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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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