TTY Biopharm


American Taiwan Biopharma
Concise Prescribing Info
Irinotecan HCl trihydrate
Advanced colorectal cancer in combination w/ 5-fluorouracil (5-FU) & folinic acid (FA) in patients w/o prior chemotherapy for advanced disease or as a single agent in patients who have failed an established 5-FU containing treatment regimen.
Dosage/Direction for Use
Monotherapy (previously treated patient) 300-350 mg/m2 IV infusion over 30-90 min every 3 wk. Combination w/ 5-FU & FA (for previously untreated patient) 180 mg/m2 IV infusion over 30-90 min once every 2 wk followed by FA & 5 FU infusion.
Hypersensitivity. Chronic inflammatory bowel disease &/or bowel obstruction. Patients w/ bilirubin >1.5x ULN; severe bone marrow failure; presenting a risk factor, particularly those w/ WHO performance status >2. Pregnancy & lactation.
Special Precautions
Patients presenting a risk factor, particularly those w/ WHO performance status 2. Increased risk of delayed diarrhea especially in patients w/ previous abdominal/pelvic radiotherapy, baseline hyperleukocytosis, performance status ≥2 & women. Infections & hematological toxicity. Prophylactic treatment w/ antiemetic before each treatment is recommended. Prophylactic treatment w/ atropine sulfate in acute or severe cholinergic syndrome. Acute cholinergic syndrome. Renal impairment. Treat bowel obstruction before therapy. Renal insufficiency, hypotension or circulatory failure. Perform complete blood cell counts; liver function tests at baseline & before each cycle. Take contraceptive measures during & for at least 3 mth after cessation of therapy. Women of childbearing potential. Minor or moderate influence on the ability to drive & use machine. Elderly.
Adverse Reactions
Delayed diarrhea, nausea & vomiting, dehydration, constipation; neutropenia; severe transient acute cholinergic syndrome; dyspnea, muscular contraction or cramps & paresthesia; asthenia; alopecia; fever; transient & mild to moderate increase in serum levels of transaminases, alkaline phosphatase, bilirubin, creatinine.
Drug Interactions
May prolong neuromuscular blocking effects of suxamethonium. May antagonize 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.
Irino soln for infusion (conc) 20 mg/mL
5 mL x 1's
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