Drug Action
Irinotecan inhibits topoisomerase I, an enzyme involved in DNA replication.
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Drug reference
Irinotecan inhibits topoisomerase I, an enzyme involved in DNA replication.
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Metastatic colorectal cancer in combination with fluorouracil and folinic acid or as monotherapy when treatment containing fluorouracil has failed | Treatment of epidermal growth factor receptor-expressing metastatic colorectal cancer after failure of chemotherapy that has included irinotecan (in combination with cetuximab) | First-line treatment of metastatic carcinoma of the colon or rectum (in combination with fluorouracil, folinic acid and bevacizumab) | First-line treatment of metastatic colorectal carcinoma (in combination with capecitabine with or without bevacizumab) ▶BY INTRAVENOUS INFUSION ▶Adult: (consult product literature or local protocols) Metastatic adenocarcinoma of the pancreas in patients who have progressed following gemcitabine based therapy (in combination with fluorouracil and leucovorin) (specialist use only) ▶BY INTRAVENOUS INFUSION USING LIPID FORMULATION ▶Adult: (consult product literature or local protocols)
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Bowel obstruction. chronic inflammatory bowel disease
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Raised plasma-bilirubin concentration. risk factors for cardiac disease. risk factors for pulmonary toxicity. underweight patients—increased risk of adverse events
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Irinotecan is available as both conventional and liposomal formulations. These different formulations vary in their licensed indications, pharmacokinetics, dosage and administration, and are not interchangeable.
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NICE decisions ▶Pegylated liposomal irinotecan for treating pancreatic cancer after gemcitabine (April 2017) NICE TA440 Pegylated liposomal irinotecan, in combination with fluorouracil and leucovorin, is not recommended for treating metastatic adenocarcinoma of the pancreas in adults whose disease has progressed after gemcitabine- based therapy. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their clinician consider it appropriate to stop. www.nice.org.uk/guidance/TA440 Scottish Medicines Consortium (SMC) decisions The Scottish Medicines Consortium has advised (March 2017) that liposomal irinotecan (Onivyde ®) is not recommended for use within NHS Scotland for the treatment of metastatic adenocarcinoma of the pancreas, in combination with fluorouracil and leucovorin (folinic acid), in patients who have progressed following gemcitabine based therapy as there was insufficient evidence submitted.
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MHRA/CHM ADVICE: ONIVYDE ® (IRINOTECAN, LIPOSOMAL FORMULATIONS): REPORTS OF SERIOUS AND FATAL THROMBOEMBOLIC EVENTS (MARCH 2019) Onivyde ® has been associated with reports of serious thromboembolic events, such as pulmonary embolism, venous thrombosis, and arterial thromboembolism. Healthcare professionals are advised to obtain a thorough medical history to identify patients with multiple risk factors. Patients should be advised to seek medical advice immediately if signs or symptoms of thromboembolism occur, such as sudden pain and swelling in a leg or an arm, sudden onset of coughing, chest pain or difficulty breathing.
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→Appendix 1: irinotecan
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▶Common or very common Alopecia. anaemia (dose- Immune system and malignant disease limiting). appetite decreased. asthenia. cholinergic syndrome. constipation. decreased leucocytes. diarrhoea (delayed diarrhoea requires prompt treatment). dizziness. dysphonia. dyspnoea. electrolyte imbalance. embolism and thrombosis. febrile neutropenia (dose-limiting). fever . fluid imbalance. gastrointestinal discomfort. gastrointestinal disorders. hypoalbuminaemia. hypoglycaemia. hypotension. increased risk of infection. infusion related reaction. insomnia. mucositis. nausea. neutropenia (dose-limiting). oedema. renal impairment. sepsis. stomatitis. taste altered. thrombocytopenia (dose- limiting). vomiting. weight decreased ▶Uncommon Hypersensitivity. hypoxia. nail discolouration . skin reactions ▶Frequency not known Antibiotic associated colitis. circulatory collapse. gastrointestinal haemorrhage. hiccups. hypertension. interstitial lung disease. muscle cramps. paraesthesia. speech disorder. ulcerative colitis
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For conventional formulations, manufacturer advises effective contraception during treatment and for up to 1 month after treatment in women of child-bearing potential, and up to 3 months after treatment in men. For liposomal formulations, manufacturer advises effective contraception during treatment and for up to 1 month after treatment in women of child-bearing potential, and up to 4 months after treatment in men.
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Manufacturer advises avoid unless essential—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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For conventional formulations, manufacturer advises avoid. For liposomal formulations, manufacturer advises avoid until one month after the last dose—no information available.
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For conventional formulations, manufacturer advises caution if bilirubin concentration 1.5–3 times the upper limit of normal (risk of decreased clearance)—monitor liver function at baseline and before each cycle; avoid if bilirubin concentration greater than 3 times the upper limit of normal (no information available for combination therapy). For liposomal formulations, manufacturer advises caution; avoid if bilirubin greater than 2 mg/dL, or if transaminases are greater than 2.5 times the upper limit of normal, or greater than 5 times the upper limit of normal if liver metastasis present (limited information available). Dose adjustments For conventional formulations, manufacturer advises dose reduction—consult product literature.
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For conventional formulations, manufacturer advises avoid—no information available. For liposomal formulations, manufacturer advises avoid in severe impairment—no information available.
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Manufacturer advises monitor for respiratory symptoms in patients with risk factors for interstitial lung disease before and during treatment; monitor complete blood count weekly during treatment.
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion ELECTROLYTES: May contain Sodium ▶Irinotecan hydrochloride (Non-proprietary) Irinotecan hydrochloride trihydrate 20 mg per 1 ml Irinotecan 500mg/25ml concentrate for solution for infusion vials | 1 vial P £172.50–£767.36 (Hospital only) Irinotecan 40mg/2ml concentrate for solution for infusion vials | 1 vial P £15.00–£53.00 (Hospital only) | 1 vial P £49.03– £54.84 Irinotecan 300mg/15ml concentrate for solution for infusion vials | 1 vial P £110.00–£390.00 (Hospital only) | 1 vial P £370.50– £403.34 Irinotecan 100mg/5ml concentrate for solution for infusion vials | 1 vial P £48.00–£130.00 (Hospital only) | 1 vial P £120.25– £134.46 ▶Campto (Pfizer Ltd) Irinotecan hydrochloride trihydrate 20 mg per 1 ml Campto 100mg/5ml concentrate for solution for infusion vials | 1 vial P £130.00 (Hospital only) Campto 40mg/2ml concentrate for solution for infusion vials | 1 vial P £53.00 (Hospital only) Campto 300mg/15ml concentrate for solution for infusion vials | 1 vial P £390.00 (Hospital only) ▶Onivyde (Servier Laboratories Ltd) Irinotecan (as Irinotecan sucrosofate salt pegylated liposomal) 4.3 mg per 1 ml Onivyde pegylated liposomal 43mg/10ml concentrate for solution for infusion vials | 1 vial P £615.35 (Hospital only)
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Driving and skilled tasks Manufacturer advises patients and carers should be counselled on the effects on driving and performance of skilled tasks—increased risk of dizziness and visual disturbances within 24 hours of administration.
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(consult product literature or local protocols)
First-line fragment. Read the complete Indications and Dose section above.
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(consult product literature or local protocols)
First-line fragment. Read the complete Indications and Dose section above.
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