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Concentrate for solution for infusion
1× 5 , 15, 25 ml
In monotherapy (for previously treated patient):
The recommended dosage of Irinotecan Teva is 350 mg/m² administered as an intravenous infusion over a 30-90 minute period every three weeks.
In combination therapy (for previously untreated patient): Safety and efficacy of Irinotecan Teva in combination with 5-fluorouracil (5FU) and folinic acid (FA) have been assessed with the following schedule:
Irinotecan Teva plus 5FU/FA in every 2 weeks schedule.
The recommended dose of Irinotecan Teva 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.
Irinotecan Teva should be administered after appropriate recovery of all adverse events to Grade 0 or 1 NCI-CTC grading (National Cancer Institute Common Toxicity Criteria) and when treatment-related diarrhoea is fully resolved.
At the start of a subsequent infusion of therapy, the dose of Irinotecan Teva, and 5FU when applicable, should be decreased according to the worst grade of adverse events observed in the prior infusion. Treatment should be delayed by 1 to 2 weeks to allow recovery from treatment-related adverse events.
With the following adverse events a dose reduction of 15 to 20% should be applied for
Irinotecan Teva and/or 5FU when applicable:
Hematological toxicity [neutropenia Grade 4, febrile neutropenia (neutropenia Grade 3-4 and fever Grade 2-4), thrombocytopenia and leukopenia (Grade 4)], non-haematological toxicity (Grade 3-4).
Treatment with Irinotecan Teva should be continued until there is an objective progression of the disease or an unacceptable toxicity.
Please refer to the license holder for further details.
For the treatment of patients with metastatic colorectal cancer:
1. In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease.
2. As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.
For the treatment of patients with small cell lung cancer.
For the treatment of patients with gastric cancer.
Irinotecan in combination with leucovorin, Oxaliplatin and 5-fluorouracil, for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.
Hypersensitivity to the active substance or to any of the excipients.
Hypersensitivity to other medicinal products of the echinocandin class.