4.1 Therapeutic indications
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion is indicated for the treatment of patients with advanced colorectal cancer:
• In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease,
• As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion in combination with cetuximab is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, KRAS wild- type metastatic colorectal cancer, who had not received prior treatment for metastatic disease or after failure of irinotecan-including cytotoxic therapy. (see section 5.1)
Irinotecan Hydrochloride 20 mg/ml Concentrate for Solution for Infusion 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 Hydrochloride 20 mg/ml Concentrate for Solution for Infusion in combination with Capecitabine with or without bevacizumab is indicated for first – line treatment of patients with metastatic colorectal carcinoma.
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Drugs appearing in this section are approved by UK Medicines & Healthcare Products Regulatory Agency (MHRA), & the European Medicines Agency (EMA).