Active Ingredient: Irinotecan
Irinotecan is indicated for the treatment of patients with advanced colorectal cancer:
Irinotecan in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing RAS wild-type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy.
Irinotecan in combination with 5-fluorouracil, folinic acid and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.
Irinotecan in combination with capecitabine with or without bevacizumab is indicated for first-line treatment of patients with metastatic colorectal carcinoma.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
180 - 350 mg per m² of body surface area (BSA)
From 180 To 350 mg per m² of body surface area (BSA) once every 21 day(s)
In monotherapy (for previously treated patient): The recommended dosage of irinotecan is 350 mg/m² administered as an intravenous infusion over a 30- to 90-minute period every three weeks.
In combination therapy (for previously untreated patient): Safety and efficacy of irinotecan in combination with 5-fluorouracil (5FU) and folinic acid (FA) have been assessed with the following schedule.
The recommended dose of irinotecan is 180 mg/m² administered once every 2 weeks as an intravenous infusion over a 30- to 90-minute period, followed by infusion with folinic acid and 5 fluorouracil.
Normally, the same dose of irinotecan is used as administered in the last cycles of the prior irinotecan-containing regimen. Irinotecan must not be administered earlier than 1 hour after the end of the cetuximab infusion.
Intravenous infusion over a 30- to 90- minute period.
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