Increased risk of delayed diarrhea in patients who had previous abdominal/pelvic radiotherapy, w/ baseline hyperleucocytosis, performance status ≥2 & women. Patients who received previous pelvic/abdominal irradiation than in those who had not received such irradiation; baseline serum total bilirubin levels of ≥1 mg/dL. Monitor CBC wkly. Patients who experienced severe haematological events. Increased risk of infections & haematological toxicity in patients w/ severe diarrhoea. Nausea & vomiting. Acute cholinergic syndrome. Caution in patients w/ asthma. Risk factors associated w/ the development of interstitial pulmonary disease including use of pneumotoxic drugs, radiation therapy & colony stimulating factors. Avoid extravasation & monitored for signs of inflammation at infusion site. Patients w/ extensive prior irradiation (eg, >25% of bone marrow irradiated & w/in 6 wk prior to start treatment w/ irinotecan). Underlying cardiac disease, risk factors for cardiac disease, previous cytotoxic chemotherapy. Thromboembolic events (pulmonary embolism, venous thrombosis & arterial thromboembolism) in patients w/ multiple risk factors in addition to the underlying neoplasm. Avoid administration of live vaccines. Hereditary fructose intolerance. Avoid concomitant w/ a strong CYP3A4 inhibitor (eg, ketoconazole) or inducer (eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort). May affect ability to drive & use machines. Use effective contraceptive measures during & for at least 3 mth after cessation of therapy. Liver impairment; bilirubin >3 x ULN. Not recommended in renal impairment. Do not use in pregnancy. Do not use in childn. Elderly.
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