Campto

Irinotecan HCl trihydrate

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.

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 obstruction; nausea & vomiting; dizziness; preexisting lung disease; gastric cancer. Patients w/ reduced UGT1A1 activity; poor performance status. Extravasation; extensive prior irradiation. Monitor liver function before initiation & mthly or as clinically indicated. 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. Elderly ≥65 yr.

Late &/or early diarrhea, nausea, vomiting, abdominal cramping/pain, anorexia, stomatitis; leukopenia, anemia, neutropenia; asthenia, fever; decreased wt, dehydration; alopecia; thromboembolic events.

Increased systemic exposure w/ CYP3A4 &/or UGT1A1 inhibitors. Increased exposure to SN-38 w/ ketoconazole, atazanavir sulfate. Reduced exposure to SN-38 w/ CYP3A-inducing anticonvulsant drugs (eg, carbamazepine, phenobarb or phenytoin), St. John's wort. Prolonged neuromuscular blocking effects of suxamethonium. Antagonized neuromuscular blockade of non-depolarizing drugs. Exacerbated adverse effects w/ antineoplastic agents. Enhanced lymphocytopenia w/ dexamethasone. Worsened diarrhea incidence or severity w/ laxatives. Induced dehydration secondary to vomiting &/or diarrhea w/ diuretics.

Cytotoxic Chemotherapy

L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.

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