Irinotecan hydrochloride 20mg/ml; 2ml & 5ml vial: concentrate for i.v infusion.
Ind: First and second-line treatment of adult patients with metastatic colorectal cancer. Neo adjuvant cervical cancer and recurent cervicl cancer & recurrent cervical cancer. It has been shown to be effective in lung and ovarian cancer. C/I: Irinotecan is contraindicated in patients who have chronic inflammatory bowel disease and/or bowel obstruction, who have a history of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate or to any of the excipients, during pregnacy and lactation, bilirubin >1.5 times the upper limit of the normal range, severe bone marrow failure, who performance status >2.
S/E; Cautions & Warnings: See above under Alkeran & also consult manufacturer's literature. Dosage & Admin: Recommended dosage- 350mg/m2 administered by i.v infusion over a 30- to 90-minute period every 3 weeks as sin¬gle agent. Dosage adjustments- in patients who experienced asymptomatic severe neutro¬penia (neutrophil count <500 cells/mm3), fever or infections associated with neutropenia (temperature > 380C and neutrophil count <
1,0 cells/mm3) or severe diarrhoea (requiring an intravenous rehydration), dosage should be reduced from 350mg/m2 to 300mg/m2; if the patient again experiences severe neutropenia, fever or infections associated with neutropenia as defined above or severe diarrhoea, the dosage should be decreased from 300mg/m2 to 250mg/m2 at the next cycle. Delayed dosing- irinotecan should not be administered until the neutrophil count returns to above 1,500 cells/mm3. In patients who experienced severe neutropenia or severe gastrointestinal adverse events such as diarrhoea, nausea and vomiting, dosing of irinotecan should be delayed until there has been a full recovery of these symptoms, specially diarrhoea. Treatment duration- treatment with irinotecan should be continued until there is an objective progression of the disease or an unacceptable toxicity.
Special populations: patients with impaired hepatic fuction- in patients with a bilirubin < 1.5 times the ULN, patients should not be treated with irinotecan.; patients with impaired renal function- irinotecan is not recommended for use as studies in this population have not been conducted. Elderly- no specific pharmacokinetic studies have been performed in elderly, however the dose should be chosen carefully in this population due to their greater frequency of decreased biological functions, in particular hepatic function.
Drug inter: Please consult manufacturer's literature.
yote: For further information, please consult ''manufacturer's literature.
5ml (100mg) vial: 11957.63 MRP