Irinol

Irinol

irinotecan

Manufacturer:

Venus Remedies

Distributor:

Unimed
Concise Prescribing Info
Contents
Irinotecan HCl trihydrate
Indications/Uses
Advanced CRC in combination w/ 5-fluorouracil (5-FU) & folinic acid (FA) in patients w/o prior chemotherapy for advanced disease or as single agent in patients who have failed an established 5-FU containing treatment regimen.
Dosage/Direction for Use
Monotherapy Initially 125 mg/m2 every wk for 4 wk followed by 2-wk rest, or 250 mg/m2 IV infusion once every 2 wk or 350 mg/m2 once every 3 wk. Combination w/ 5-FU & FA Initially irinotecan 125 mg/m2, bolus 5-FU 500 mg/m2 & bolus FA 20 mg/m2 for 6-wk cycle or irinotecan 180 mg/m2, bolus 5-FU 400 mg/m2, 5-FU infusion 600 mg/m2 & FA 200 mg/m2 for 6-wk cycle.
Contraindications
Hypersensitivity. Chronic inflammatory bowel disease &/or obstruction; severe bone marrow failure; WHO performance status >2. Concomitant use w/ St. John's wort; live attenuated vaccines. Bilirubin >3 times ULN. Lactation.
Special Precautions
Not to be used in chronic inflammatory bowel disease &/or obstruction. Delayed diarrhoea; grade 3 & 4 neutropenia; nausea, vomiting; acute cholinergic syndrome; asthma; interstitial pulmonary disease, pulmonary infiltrates; infections, dehydration; myocardial ischaemic events; thromboembolic events eg, pulmonary embolism, venous & arterial thromboembolism; hypotension, circulatory failure. Patients w/ previous abdominal &/or pelvic RT, baseline hyperleucocytosis, performance status ≥2, extensive prior irradiation; underlying cardiac disease, other known risk factors for cardiac disease or previous cytotoxic chemotherapy; smoking, HTN, hyperlipidaemia. Monitor CBC wkly during treatment. Perform hepatic function test at baseline & prior to each cycle. Avoid extravasation & monitor for signs of inflammation at infusion site. Women. Not to be taken by patients w/ fructose intolerance. Avoid use w/ live or live attenuated vaccines; strong CYP3A4 inhibitors (eg, ketoconazole) or inducers (eg, rifampicin, carbamazepine, phenobarb, phenytoin, St. John's wort). Concomitant use w/ pneumotoxic drugs, radiation therapy, colony-stimulating factors. May affect ability to drive & use machines. Renal insufficiency. Women of childbearing potential must use effective contraception during & for 1 mth after last dose; men must use effective contraception during & for 3 mth after last dose. Not recommended in dialysis patients. Not to be used during pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Neutropenia, anaemia; decreased appetite; cholinergic syndrome; diarrhoea, vomiting, nausea, abdominal pain, constipation; reversible alopecia; mucosal inflammation, pyrexia, asthenia. Infection; thrombocytopenia, febrile neutropenia; increased blood creatinine & alkaline phosphatase, SGPT, SGOT, bilirubin.
Drug Interactions
Risk of generalised reaction w/ yellow fever vaccine, live attenuated vaccines. Decreased plasma conc w/ St. John's wort. Altered metabolism w/ strong CYP3A4 inhibitors & inducers. Reduced exposure w/ strong CYP3A4 &/or UGT1A1-inducing medicinal products eg, rifampicin, carbamazepine, phenobarb or phenytoin. Decreased digestive absorption of phenytoin. Decreased AUC w/ strong CYP3A4 inhibitors eg, ketoconazole, itraconazole, voriconazole, posaconazole, PIs, clarithromycin, erythromycin, telithromycin. Increased systemic exposure w/ UGT1A1 inhibitors eg, atazanavir, ketoconazole, regorafenib. Increased toxicity w/ other CYP3A4 inhibitors eg, crizotinib, idelalisib. Increased risk of haemorrhage & thrombotic events w/ vit K antagonists. Excessive immunosuppression w/ risk of lymphoproliferation w/ immunodepressant agents eg, ciclosporine, tacrolimus. Prolonged suxamethonium neuromuscular-blocking effects & antagonized neuromuscular blockade of non-depolarizing drugs.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Irinol infusion conc 100 mg/5 mL
Packing/Price
1's
Form
Irinol infusion conc 40 mg/2 mL
Packing/Price
1's
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