Hetero Labs


Medicell Pharma
Concise Prescribing Info
Irinotecan HCl
Advanced colorectal cancer in combination w/ 5-fluorouracil & folinic acid in patients w/o prior chemotherapy; monotherapy in patients who failed an established 5-fluorouracil containing treatment regimen.
Dosage/Direction for Use
Adult Monotherapy 350 mg/m2 IV infusion for 30-90 min every 3 wk. Combination therapy 180 mg/m2 IV infusion for 30-90 min once every 2 wk, followed by 5-fluorouracil & folinic acid infusion. Hepatic impairment Monotherapy Blood bilirubin level up to 1.5 times upper limit of normal (ULN): 350 mg/m2; 1.5-3 times ULN: 200 mg/m2.
Hypersensitivity. Chronic inflammatory bowel disease &/or obstruction. Severe bone marrow failure. WHO performance status >2. Bilirubin >3 times ULN. Pregnancy & lactation.
Special Precautions
Not to be used as IV bolus. Not to be initiated in patients w/ bowel obstruction. Patients w/ risk factors, w/ WHO performance status = 2; w/ need of immediate & prolonged antidiarrhoeal treatment combined w/ high fluid intake at onset of delayed diarrhoea. Administer prophylactic treatment w/ antiemetics prior to therapy. Homoyzygous (UGT1A1*6/*6 or UGT1A1*28/*28) or heterozygous (UGT1A1*6/*28) in allele UGT1A1*6, UGT1A1*28 of UGT. Increased risk of diarrhoea ie, previous abdominal/pelvic radiotherapy, w/ baseline hyperleucocytosis, performance status ≥2, concomitant neutropenia. Severe diarrhoea & haematological events. History of DM or evidence of glucose intolerance prior to therapy. Induced dehydration secondary to vomiting &/or diarrhea. Patients w/ asthma, experiencing acute & severe cholinergic syndrome. Risk factors associated w/ development of interstitial pulmonary disease eg, use of pneumotoxic drugs, radiation therapy & colony stimulating factors. Risk factors for cardiac disorders eg, underlying cardiac disease, previous cytotoxic chemotherapy, smoking, HTN, hyperlipidaemia. Perform liver function tests at baseline & before each cycle. Wkly monitoring of complete blood count. Patients w/ hyperbilirubinemia & prothrombin time >50%. Avoid extravasation & monitor infusion site for inflammation. May affect ability to drive & use machines. Concomitant use w/ strong CYP3A4 inhibitor (eg, ketoconazole) or inducer (eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John’s wort). Avoid vaccination w/ live vaccines. Diminished response to killed or inactivated vaccines. Hereditary fructose intolerance. Not to be used in patients w/ bilirubin >3 times ULN. Hepatic impairment. Not recommended in renal impairment. Take contraceptive measures during & at least 3 mth after therapy cessation. Avoid pregnancy in women of childbearing potential. Not to be used during lactation. Elderly.
Adverse Reactions
Delayed & severe diarrhoea; severe nausea & vomiting; dehydration; constipation; neutropenia, anaemia, thrombocytopenia; severe transient acute cholinergic syndrome, asthenia; alopecia; muscular contraction/cramps, paresthesia; increased serum transaminases, alkaline phosphatase, bilirubin & creatinine.
Drug Interactions
Increased systemic exposure w/ CYP3A4 &/or UGT1A1 inhibitors. Reduced clearance w/ ketoconazole. Increased systemic exposure w/ atazanavir sulfate. Reduced exposure w/ CYP3A-inducing anticonvulsant drugs eg, carbamazepine, phenobarb or phenytoin. Reduced exposure w/ St. John's wort. Prolonged neuromuscular blocking effects of suxamethonium. Antagonized neuromuscular blockade of non-depolarising drugs. Exacerbated ARs eg, myelosuppression & diarrhea by other antineoplastic agents w/ similar AR profile. Enhanced likelihood of lymphocytopenia w/ dexamethasone administered as antiemetic prophylaxis. Worsened incidence or severity of diarrhea w/ laxatives. Induced dehydration secondary to vomiting &/or diarrhea w/ diuretics.
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Irinox conc for soln for infusion 100 mg/5 mL
Irinox conc for soln for infusion 40 mg/2 mL
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