Irinotesin

Irinotesin

irinotecan

Manufacturer:

Actavis

Distributor:

DKLL

Marketer:

Teva Pharma
Concise Prescribing Info
Contents
Irinotecan HCl trihydrate
Indications/Uses
Advanced colorectal cancer. Treatment of epidermal growth factor receptor-expressing metastatic colorectal cancer after failure of irinotecan including cytotoxic therapy in combination w/ cetuximab. 1st-line treatment of metastatic carcinoma of the colon or rectum in combination w/ 5-FU, folinic acid & bevacizumab.
Dosage/Direction for Use
Combination therapy for previously untreated patient 180 mg/m2 once every 2 wk IV infusion over 30-90 min followed by infusion w/ folinic acid & 5-FU. Monotherapy for previously treated patient 350 mg/m2 IV infusion over 30-90 min every 3 wk.
Contraindications
Hypersensitivity. Chronic inflammatory bowel disease &/or bowel obstruction. Bilirubin >3 times the ULN, severe bone marrow failure, WHO performance status >2, concomitant use w/ St. John's wort. Pregnancy & lactation.
Special Precautions
Impaired hepatic & renal function. Patients at risk of severe neutropenia. Risk of delayed diarrhoea. Monitor CBC. Antiemetics should be taken before each treatment. Acute cholinergic symptoms, asthma, bowel obstruction, fructose intolerance. Monitor patients at risk of interstitial pulmonary disease. May impair ability to drive or operate machinery. Childn. Elderly.
Adverse Reactions
Diarrhoea, nausea & vomiting, neutropenia, anemia, thrombocytopenia, reversible alopecia. Dehydration, constipation, fever w/ severe neutropenia, severe transient acute cholinergic syndrome, asthenia, increased transaminases, alkaline phosphate or bilirubin serum levels.
Drug Interactions
Prolong neuromuscular blocking effects of suxamethonium. Reduced exposure & pharmacodynamic effects w/ CYP3A-inducing anticonvulsant drugs (eg, carbamazepine, phenobarb, or phenytoin). Altered metabolism w/ CYP450 3A4 inhibitor/inducer. Decrease in the active metabolite & plasma levels w/ St. John's wort. Diarrhea & leukopenia may occur w/ bevacizumab.
ATC Classification
L01CE02 - irinotecan ; Belongs to the class of Topoisomerase 1 (TOP1) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Irinotesin inj 100 mg/5 mL
Packing/Price
1's
Form
Irinotesin inj 40 mg/2 mL
Packing/Price
1's
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