DBL Irinotecan

DBL Irinotecan





Zuellig Pharma


Concise Prescribing Info
Irinotecan HCl
Advanced colorectal cancer in combination w/ 5-fluorouracil & folinic acid in patients w/o prior chemotherapy for advanced disease. Monotherapy in patients who have failed an established 5-fluorouracil-containing treatment regimen.
Dosage/Direction for Use
Monotherapy for previously treated adult 350 mg/m2 IV infusion over 30-90 min every 3 wk. Combination therapy for previously untreated adult 180 mg/m2 IV infusion over 30-90 min once every 2 wk, followed by infusion w/ folinic acid & 5-fluorouracil. Patient w/ bilirubin up to 1.5 times upper limit of normal (ULN) 350 mg/m2, bilirubin 1.5-3 times ULN 200 mg/m2.
Hypersensitivity. Women of childbearing potential. Pregnancy & lactation.
Special Precautions
Not to be used in patients w/ severe bone marrow failure; neutrophil count <1.5 x 109/L. Severe myelosuppression. Early & late diarrhoea, colitis/ileus, chronic inflammatory bowel disease &/or bowel obstruction. Patients w/ poor performance status, previous pelvic/abdominal irradiation; asthma or CV diseases, mechanical intestinal or urinary obstruction; preexisting lung disease; nausea & vomiting; evidence of infection; dehydration symptoms; bloody or black stools; alopecia. Monitor WBC w/ differential, Hb & platelet count; liver function before therapy initiation. Avoid extravasation & monitor infusion site for signs of inflammation. Concomitant use w/ pneumotoxic drugs, radiation therapy & colony stimulating factors. Avoid laxative use. Hereditary fructose intolerance. Not recommended on dialysis patients. Renal & hepatic impairment. Avoid use during pregnancy. Not to be used lactation. Childn. Elderly >65 yr.
Adverse Reactions
Diarrhoea, nausea, vomiting, abdominal cramping/pain, anorexia, constipation, flatulence, stomatitis, dyspepsia; leucopenia, anaemia, neutropenia, thrombocytopenia; asthenia, fever, pain, headache, back pain, chills, minor infection, oedema, abdominal enlargement; wt reduction, dehydration, increased alkaline phosphatase, SGOT & bilirubin; exfoliative dermatitis, hand & foot syndrome, cutaneous signs, alopecia, sweating, rash; dyspnoea, increased coughing, rhinitis, pneumonia; dizziness, somnolence, confusion; vasodilation, hypotension, thrombophlebitis, pulmonary embolus, MI.
Drug Interactions
Prolonged suxamethonium neuromuscular blocking effects & antagonized neuromuscular blockade of non-depolarizing drugs. Exacerbated adverse effects w/ antineoplastics. Reduced exposure to SN-38 w/ anticonvulsants eg, carbamazepine, phenobarb, phenytoin; St. John's wort. Reduced clearance by ketoconazole. Increased systemic exposure to SN-38 w/ atazanavir sulfate. Enhanced lymphocytopenia w/ dexamethasone. Increased incidence of akathisia w/ prochlorperazine. 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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