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In monotherapy (for previously treated patients): The recommended dosage of IRITERO 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 patients): Safety and efficacy of IRITERO in combination with 5-fluorouracil (5-FU) and Folinic acid (FA) have been assessed with the following schedule. The recommended dosage of IRITERO 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 in combination with Cisplatin: The recommended starting dose is 65 mg/m2 of Irinotecan and 30 mg/m2 of Cisplatin. Cisplatin infused prior to Irinotecan. A lower starting dose of Irinotecan may be considered for patients with any of the following conditions: Age 65 years and older, prior extensive radiotherapy, performance status of 2, increased bilirubin levels, or gastric cancer. Treatment should be given in repeated 6-week cycles, comprising days 1 and 8, every 21 days.
Irinotecan should be administered as an intravenous infusion over 30 to 90 minutes.
Dosage adjustment: IRITERO 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 diarrhea is fully resolved.
At the start of a subsequent infusion of therapy, the dose of IRITERO, 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 IRITERO 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-hematological toxicity (grade 3 - 4).
Duration of treatment: For both single-agent and combination-agent regimens, treatment with additional cycles of Irinotecan may be continued indefinitely in patients who attain a tumor response or in patients whose cancer remains stable. Patients should be carefully monitored for toxicity and should be removed from therapy if unacceptable toxicity occurs that responsive to dose modifications and routine supportive care.
Modification recommendations: Recommended dose modification for Irinotecan and Cisplatin for the start of each cycle of therapy are described in Table 1, while recommended dose modifications during a cycle of therapy are described in Table 2. (See Table 1 and Table 2.)
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Click on icon to see table/diagram/imageSpecial population: Elderly: The dose should be chosen carefully in this population due to their greater frequency of decreased biological functions. These populations should require more intensive surveillance.
Patients with impaired hepatic function: In monotherapy: In patients with hyperbilirubinemia and prothrombin greater than 50%, the clearance of Irinotecan is decreased and therefore, the risk of hematotoxicity is increased. Thus, frequent 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 IRITERO is 350 mg/m2.
In patients with bilirubin ranging from 1.5 to 3 times the ULN, the recommended dosage of IRITERO is 200 mg/m2.
Patients with bilirubin beyond to 3 times the ULN should not be treated with IRITERO.
No date are available in patients with hepatic impairment treated by IRITERO in combination.
Patients with impaired renal functions: IRITERO is not recommended for use in patients with impaired renal functions.
Preparation and handling: As with other antineoplastic agents, IRITERO must be prepared and handled with caution. The usage of glasses, mask and gloves is required. If IRITERO solution or infusion solution come into contact with the mucus membranes, wash immediately with water.
Preparation for intravenous infusion administration: As with any other injectable drugs, the IRITERO solution must be prepared aseptically. If any precipitate is observed in the vials or after reconstitution, the product should be discarded according to standard procedures for cytotoxic agents. Aseptically withdraw the required amount of IRITERO solution from the vial with a calibrated syringe and inject into a 250 ml infusion bag or bottle containing either 0.9% Sodium chloride solution or 5% Dextrose solution. The infusion is then thoroughly mixed by manual rotation.
Administration: IRITERO solution for infusion should be infused into a peripheral or central wein. IRITERO should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.
Disposal: All material used for dilution and administration should be disposed of according to hospital standard procedure applicable to cytotoxic agents.
