Iritero

Iritero

irinotecan

Manufacturer:

Hetero Labs

Distributor:

Camber
Concise Prescribing Info
Contents
Irinotecan HCl
Indications/Uses
Advanced colorectal cancer in combination w/ 5-fluorouracil (5FU) & folinic acid (FA) in patients w/o prior chemotherapy for advanced disease. Single agent in patients who have failed an established 5FU containing treatment regimen. Epidermal growth factor receptor-expressing, KRAS wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy in combination w/ cetuximab. First-line treatment of patients w/ metastatic carcinoma of the colon or rectum in combination w/ 5FU, FA & bevacizumab. First-line treatment of patients w/ metastatic colorectal carcinoma in combination w/ capecitabine w/ or w/o bevacizumab.
Dosage/Direction for Use
IV infusion Monotherapy for previously treated patient 350 mg/m2 over 30-90 min every 3 wk. In combination therapy w/ 5FU & FA for previously untreated patient 180 mg/m2 once every 2 wk over 30-90 min, followed by infusion w/ FA & 5FU. Patients w/ bilirubin up to 1.5 x ULN 350 mg/m2; 1.5-3 x ULN 200 mg/m2. In combination w/ capecitabine ≥65 yr 800 mg/m2 bid.
Contraindications
History of severe hypersensitivity reactions. Chronic inflammatory bowel disease &/or bowel obstruction. Severe bone marrow failure. Bilirubin >3 x ULN. Lactation.
Special Precautions
Risk of delayed diarrhea. Wkly monitoring of complete blood cell count is recommended. Perform liver function test. Nausea & vomiting. Acute cholinergic symptoms. Resp disorders. Avoid extravasation & monitor infusion site for signs of inflammation. Chronic inflammatory bowel disease &/or bowel obstruction. Myocardial ischaemic events. Avoid vaccination w/ live vaccines. Renal impairment. May impair ability to drive or operate machinery. Pregnancy & lactation. Elderly.
Adverse Reactions
In combination w/ capecitabine: Thrombosis/embolism. Hypersensitivity reaction, cardiac ischemia/infarction; febrile neutropenia. In combination w/ capecitabine & bevacizumab: Neutropenia, thrombosis/embolism, HTN & cardiac ischemia/infarction. Severe diarrhea. Dehydration. Neutropenia; fever w/ severe neutropenia; anemia, thrombocytopenia; alopecia; muscular contraction or cramps & paresthesia. Monotherapy: Nausea & vomiting; constipation; severe transient acute cholinergic syndrome; asthenia; transient & mild to moderate increases in serum levels of either transaminases, alkaline phosphatase or bilirubin.
Drug Interactions
May prolong neuromuscular blocking effects of suxamethonium & may antagonise neuromuscular blockade of non-depolarising drugs. Reduced exposure w/ carbamazepine, phenobarb or phenytoin. May inhibit metabolism w/ ketoconazole or induce w/ rifampicin, carbamazepine, phenobarb or phenytoin. Potential to increase systemic exposure w/ atazanavir sulphate. Risk of fatal generalized reaction to yellow fever vaccine; risk of systemic, possible fatal disease (eg, infections) w/ live attenuated vaccines (except yellow fever); risk of exacerbation of convulsions resulting from the decrease of phenytoin digestive absorption or risk of toxicity enhancement due to increased hepatic metabolism by phenytoin; risk of lymphoproliferation w/ ciclosporine, tacrolimus.
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
Iritero soln for IV infusion 100 mg/5 mL
Packing/Price
5 mL x 1's
Form
Iritero soln for IV infusion 40 mg/2 mL
Packing/Price
2 mL x 1's
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