Generic Medicine Info
Chronic inflammatory bowel disease and/or bowel obstruction, severe bone marrow failure, WHO performance status >2. Conventional formulation: Bilirubin >3 times the ULN. Liposomal formulation: Bilirubin >2 mg/dL, or AST/ALT >2.5 times the ULN or >5 times the ULN if liver metastasis is present. Pregnancy and lactation. Concomitant use with live attenuated vaccines (e.g. yellow fever vaccine) and St. John's wort.
Special Precautions
Patients with abnormal or deficient bilirubin glucuronidation (e.g. Gilbert syndrome), hyperbilirubinaemia, previously received pelvic/abdominal irradiation, history of Whipple procedure, asthma, underlying cardiac disease, other risk factors for cardiac disease (e.g. hypertension, hyperlipidaemia, smoking); underweight patients (BMI <18.5 kg/m2). Avoid extravasation. Renal and hepatic impairment. UGT1A1 poor metabolisers and those who are homozygous for UGT1A1*28 alleles. Patient Counselling This drug may cause potential dizziness or visual disturbances, if affected, do not drive or operate machinery. Monitoring Parameters Monitor CBC with differential, platelet count, and Hb with each dose; LFTs at baseline and before each cycle; bilirubin and electrolytes especially during severe diarrhoea; bowel movements and hydration status; genotyping of UGT1A1. Assess for signs and symptoms of neutropenia, delayed diarrhoea, sepsis, cholinergic reactions, pulmonary toxicity, hypersensitivity or infusion site reactions (e.g. inflammation, extravasation).
Adverse Reactions
Significant: Bone marrow suppression (e.g. lymphopenia, leucopenia, anaemia, thrombocytopenia), gastrointestinal toxicity (e.g. nausea, vomiting), acute cholinergic syndrome, myocardial ischaemic events, renal toxicity (e.g. increased serum creatinine or BUN, acute renal failure), severe hypersensitivity reactions (including anaphylaxis). Gastrointestinal disorders: Abdominal pain, constipation, dysgeusia, stomatitis, colitis, pancreatitis, hiccups. General disorders and administration site conditions: Pyrexia, asthenia, fatigue, mucosal inflammation, peripheral oedema, infusion related reaction. Hepatobiliary disorders: Hypoalbuminaemia. Infections and infestations: Infection, gastroenteritis, oral candidiasis. Investigations: Weight decreased, increased blood bilirubin, elevated ALT/AST and blood alkaline phosphatase, increased INR. Metabolism and nutrition disorders: Decreased appetite, hypokalaemia, dehydration, hypomagnesaemia, hypoglycaemia, hyponatraemia, hypophosphataemia. Nervous system disorders: Dizziness. Psychiatric disorders: Insomnia. Respiratory, thoracic and mediastinal disorders: Dyspnoea, dysphonia, pneumonia. Skin and subcutaneous tissue disorders: Alopecia (reversible). Vascular disorders: Hypotension, haemorrhoids.
Potentially Fatal: Severe neutropenic fever or sepsis, severe neutropenia, severe myelosuppression, severe late-onset diarrhoea, severe interstitial lung disease, thromboembolic events (e.g. pulmonary embolism, venous thrombosis, arterial thromboembolism).
Drug Interactions
Reduced exposure with strong CYP3A4 and/or UGT1A1 inducers (e.g. rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin). Increased toxic effect and plasma levels with bevacizumab. Increased systemic exposure and risk of toxicity with strong CYP3A4 inhibitors (e.g. ketoconazole, voriconazole, protease inhibitors, clarithromycin, erythromycin, crizotinib, idelalisib), and UGT1A1 inhibitors (e.g. atazanavir, gemfibrozil, regorafenib). Increased risk of excessive immunosuppression and lymphoproliferation with immunodepressant agents (e.g. ciclosporin, tacrolimus). May prolong neuromuscular blocking effects of suxamethonium.
CIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CE02 - irinotecan
Disclaimer: This information is independently developed by CIMS based on irinotecan from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by
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