In combination w/ 5-fluorouracil (5-FU) & folinic acid for advanced CRC in patients w/o prior chemotherapy for advanced disease or as single agent in patients who have failed an established 5-FU containing treatment regimen.
Monotherapy 100-125 mg/m2 over 30-90 min IV infusion once wkly or 200-250 mg/m2 over 30-90 min IV infusion once every 2 wk, or 300-350 mg/m2 over 30-90 min IV infusion once every 3 wk. Combination therapy Starting dose: Irinotecan 125 mg/m2, bolus 5-FU 500 mg/m2 & folinic acid 20 mg/m2 for 6 wk or irinotecan 180 mg/m2, bolus 5-FU 400 mg/m2, 5-FU infusion 600 mg/m2 & folinic acid 200 mg/m2 for 6 wk.
Hypersensitivity. Discontinue use temporarily if neutropenic fever or ANC <1,000/mm3 occurs. Not to be used in patients w/ severe bone marrow failure. Cholinergic symptoms; hematology toxicities; late diarrhea; chronic inflammatory bowel disease &/or bowel obstruction; nausea & vomiting; preexisting lung disease; gastric cancer. Symptomatic evidence of orthostatic hypotension in patients w/ dehydration. Patients w/ reduced UGT1A1 activity; poor performance status. Extravasation; extensive prior irradiation. Unsuitable in hereditary fructose intolerance. Avoid use w/ live or live-attenuated vaccines. Concomitant use w/ pneumotoxic drugs, radiation therapy & colony-stimulating factors. May affect ability to drive & use machines. Not recommended for dialysis patients. Hepatic insufficiency. Renal dysfunction. Women of childbearing potential should use effective contraception during & for 6 mth after last dose. Male patients should use effective contraception during & for 3 mth after last dose. Not to be used during pregnancy & lactation. Ped patients. Elderly ≥65 yr.
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