Irinocan 40/Irinocan 100 Dosage/Direction for Use

Irinotecan Hydrochloride Trihydrate Injection 20 mg/mL is indicated in adults. After dilution Irinotecan Hydrochloride Trihydrate Injection should be infused into a peripheral or central vein.
Recommended dosage: In monotherapy (for previously treated patient): The recommended dosage of Irinotecan Hydrochloride Trihydrate Injection 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 Hydrochloride Trihydrate Injection 20 mg/mL in combination with 5-fluorouracil (5FU) and folinic acid (FA) have been assessed with the following schedule: Irinotecan Hydrochloride Trihydrate Injection 20 mg/mL plus 5FU/FA in every 2 weeks schedule.
The recommended dose of Irinotecan Hydrochloride Trihydrate Injection 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.
For the posology and method of administration of concomitant Cetuximab, refer to the product information for this medicinal product.
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.
For the posology and method of administration of Bevacizumab, refer to the Bevacizumab summary product of characteristics.
For the posology and method of administration of Capecitabine combination, please refer to the appropriate sections in the Capecitabine summary of product characteristics.
Dosage adjustments: Irinotecan Hydrochloride Trihydrate Injection 20 mg/mL 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 Hydrochloride Trihydrate Injection, 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 Hydrochloride Trihydrate Injection and/or 5FU when applicable: haematological 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).
Recommendations for dose modifications of Cetuximab when administered in combination with Irinotecan must be followed according to the product information for this medicinal product.
Refer to the Bevacizumab summary product of characteristics for dose modifications of Bevacizumab when administered in combination with Irinotecan Hydrochloride Trihydrate Injection/5FU/FA.
In combination with Capecitabine for patients 65 years of age or more, a reduction of the starting dose of Capecitabine to 800 mg/m² twice daily is recommended according to the summary of product characteristics for Capecitabine. Refer also to the recommendations for dose modifications in combination regimen given in the summary of product characteristics for Capecitabine.
Treatment Duration: Treatment with Irinotecan Hydrochloride Trihydrate Injection 20 mg/mL should be continued until there is an objective progression of the disease or an unacceptable toxicity.
Special populations: Patients with Impaired Hepatic Function: In monotherapy: Blood bilirubin levels [up to 3 times the upper limit of the normal range (ULN)] in patients with performance status ≤ 2, should determine the starting dose of Irinotecan Hydrochloride Trihydrate Injection. In these patients with hyper bilirubinemia and prothrombin time greater than 50%, the clearance of Irinotecan is decreased and therefore the risk of hematotoxicity is increased. Thus, weekly monitoring of complete blood counts should be conducted in this patient population.
In patients with bilirubin up to 1.5 times the upper limit of the normal range (ULN), the recommended dosage of Irinotecan Hydrochloride Trihydrate Injection is 350 mg/m².
In patients with bilirubin ranging from 1.5 to 3 times the ULN, the recommended dosage of Irinotecan Hydrochloride Trihydrate Injection is 200 mg/m².
Patients with bilirubin beyond 3 times the ULN should not be treated with Irinotecan Hydrochloride Trihydrate Injection.
No data are available in patients with hepatic impairment treated by Irinotecan Hydrochloride Trihydrate Injection in combination.
Patients with Impaired Renal Function: Irinotecan Hydrochloride Trihydrate Injection is not recommended for use in patients with impaired renal function, 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. This population should undergo more intense surveillance.
Paediatric population: Irinotecan should not be used in children.
Method of administration: Precautions should be taken before handling or administering the medicinal product.
Irinotecan Hydrochloride Trihydrate Injection is cytotoxic. For information regarding dilution, and special precautions for disposal and other handling see Special precautions for disposal and other handling under Cautions for Usage.
Irinotecan concentrate for solution for infusion should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.