Package(a):
CONCENTRATE FOR INFUSION: 2 ml x 40 mg. Dosage(a):
Monotherapy (for previously treated patient): 350 mg/m2 as an I.V. infusion over a 30-90 minutes period every 3 weeks.
Combination therapy (for previously untreated patients): 180 mg/m2 once every 2 weeks as an I.V. infusion over a 30-90 minute period, followed by an infusion with folinic acid and 5-fluourouracil. See prescribing information for full details. Prescribing Restrictions:
Package(b):
CONCENTRATE FOR INFUSION: 5 ml x 100 mg.
Dosage(b):
Monotherapy (for previously treated patient): 350 mg/m2 as an I.V. infusion over a 30-90 minutes period every 3 weeks.
Combination therapy (for previously untreated patients): 180 mg/m2 once every 2 weeks as an I.V. infusion over a 30-90 minute period, followed by an infusion with folinic acid and 5-fluourouracil. See prescribing information for full details. Prescribing Restrictions:
Package(c):
CONCENTRATE FOR INFUSION: 25 ml x 500 mg. Dosage(c):
Monotherapy (for previously treated patient): 350 mg/m2 as an I.V. infusion over a 30-90 minutes period every 3 weeks.
Combination therapy (for previously untreated patients): 180 mg/m2 once every 2 weeks as an I.V. infusion over a 30-90 minute period, followed by an infusion with folinic acid and 5-fluourouracil. See prescribing information for full details. Prescribing Restrictions:
Indications:
Treatment of patients with metastatic colorectal cancer in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease; as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. Treatment of patients with small cell lung cancer. Treatment of patients with gastric cancer. Contra-Indications:
Chronic inflammatory bowel disease and/or bowel obstruction. Hypersensitivity to irinotecan or any of the excipients. Pregnancy and lactation. Bilirubin >3 times the upper limit of the normal range, severe bone marrow failure, WHO performance status >2, concomitant use with St. John’s Wort. Special Precautions:
Should only be administered under the supervision of a physician qualified in the use of anticancer chemotherapy. See prescribing information for full details. Side Effects:
See prescribing information for full details. Drug Interactions:
Neuromuscular blocking agents. CYP3A-inducing anticonvulsant drugs (e.g., rifampicin, carbamazepine, phenobarbital or phenytoin). Consideration should be given to starting or substituting non-enzyme-inducing anticonvulsants at least one week prior to initiation of irinotecan therapy (e.g., ketoconazole) in patients requiring anticonvulsant treatment.
