DBL Irinotecan

DBL Irinotecan





Zuellig Pharma
Concise Prescribing Info
Irinotecan HCl
Advanced CRC in combination w/ 5-fluorouracil (5-FU) & folinic acid in patients w/o prior chemotherapy for advanced disease. Monotherapy in patients who have failed an established 5-FU-containing treatment regimen.
Dosage/Direction for Use
Monotherapy 125 mg/m2 IV infusion over 30-90 min every wk or 250 mg/m2 IV infusion over 30-90 min every 2 wk, or 350 mg/m2 IV infusion over 30-90 min every 3 wk. Combination w/ 5-FU & leucovorin Irinotecan 125 mg/m2, bolus 5-FU 500 mg/m2 & bolus leucovorin 20 mg/m2 for 6-wk cycle or irinotecan 180 mg/m2, bolus 5-FU 400 mg/m2, 5-FU infusion 600 mg/m2 & leucovorin 200 mg/m2 for 6-wk cycle.
Special Precautions
Hypersensitivity reactions. Discontinue if neutropenic fever occur or ANC <1,000/mm3. Not to be used in patients w/ severe bone marrow failure. Cholinergic symptoms; previous pelvic/abdominal irradiation; early & late diarrhoea, colitis/ileus; chronic inflammatory bowel disease &/or bowel obstruction; nausea, vomiting; dizziness; preexisting lung disease; gastric cancer. Patients w/ poor performance status, reduced UGT1A1 activity. Avoid extravasation & monitor infusion site for signs of inflammation. Monitor hepatic function prior to therapy. Avoid use w/ live or live attenuated vaccine. Concomitant use w/ pneumotoxic drugs, radiation therapy & colony stimulating factors. Unsuitable in hereditary fructose intolerance. May affect ability to drive & use machines. Not recommended on dialysis patients. Renal & hepatic impairment. 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. Avoid use during pregnancy. Not recommended during lactation. Childn. Elderly >65 yr.
Adverse Reactions
Late/early diarrhea, nausea, vomiting, abdominal cramping/pain, anorexia, stomatitis; leukopenia, anemia, neutropenia; asthenia, fever; decreased wt, dehydration; alopecia; thromboembolic events eg, angina pectoris, arterial thrombosis, cerebral infarct, CVA, deep thrombophlebitis, lower extremity embolus, heart arrest, MI, myocardial ischemia, peripheral vascular disorder, pulmonary embolus, sudden death, thrombophlebitis, thrombosis, vascular disorder. Infection; constipation, mucositis; thrombocytopenia; pain; hypovolemia; bilirubinemia; dyspnea; increased creatinine.
Drug Interactions
Increased systemic exposure to SN-38 w/ CYP3A4 &/or UGT1A1 inhibitors, ketoconazole, atazanavir sulfate. Reduced exposure to SN-38 w/ CYP3A-inducing anticonvulsants eg, carbamazepine, phenobarb, phenytoin; St. John's wort. Prolonged suxamethonium neuromuscular blocking effects & antagonized neuromuscular blockade of non-depolarizing drugs. Exacerbated adverse effects w/ other antineoplastics. Enhanced lymphocytopenia w/ dexamethasone. Worsened diarrhoea incidence or severity w/ laxatives. Potential risk of dehydration secondary to vomiting &/or diarrhoea w/ diuretics.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
DBL Irinotecan inj conc 20 mg/mL
(single-use) 2 mL x 1's; (single-use) 5 mL x 1's
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