IRNIZET 100 CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/5ML

APOTHECA MARKETING PTE LTD

APOTHECA MARKETING PTE LTD

Therapeutic

Prescription Only

INFUSION, SOLUTION CONCENTRATE

**4.2 Posology and method of administration** Dosage For adults only - In monotherapy (for previously treated patient): The recommended dose of Irinotecan is 350 mg/m2 administered in the form of intravenous infusion over 30 to 90 minute period every three weeks. - In combination therapy (for previously untreated patient): Safety and efficacy of Irinotecan in combination with 5-fluorouracil (5-FU) and folinic acid (FA) have been assessed with the following schedule: Irinotecan plus 5-FU/FA in every 2 weeks schedule.The recommended dose of Irinotecan is 180 mg/m2 administered once every 2 weeks as an intravenous infusion over 30 to 90 minute period, followed by infusion with FA and 5-FU. Dose adjustments Irinotecan should be administered after an appropriate recovery from all adverse events to grade 0 or 1 according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) scale and when treatment–related diarrhoea is fully resolved. At the beginning of subsequent administration of infusion therapy, the dose of Irinotecan and 5-FU, where applicable, should be reduced according to the worst degree of adverse effects observed over the previous administration. The treatment should be delayed for 1–2 weeks to allow recovery from adverse effects associated with treatment. In the presence of the following adverse effects, the dose should be reduced by 15 to 20% in relation to Irinotecan and/or 5-FU, where applicable: - haematological toxicity (grade 4 neutropenia, febrile neutropenia \[grade 3–4 neutropenia and grade 2–4 fever\], thrombocytopenia and leucopoenia \[grade 4\]), - non- haematological toxicity (grade 3–4). Duration of the treatment The treatment with Irinotecan should be continued until there is objective disease progression or unacceptable toxicity. Special populations Patients with impaired hepatic function _In Monotherapy_: In patients with hyperbilirubinemia and a prothrombin time greater than 50%, clearance of Irinotecan is reduced (see section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_), and therefore the risk of haematological toxicity is increased. Thus, frequent monitoring of complete blood counts should be conducted in this patient population. - In patients with bilirubin levels up to 1.5 times the upper limit of normal (ULN), the recommended dose of Irinotecan is 350 mg/m2 - In patients with bilirubin levels between 1.5 to 3 times the ULN, the recommended dose of Irinotecan is 200 mg/m2 - Patients with bilirubin levels above 3 times the ULN, should not be treated with Irinotecan (see sections 4.3 and 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data are available for patients with impaired hepatic function treated with Irinotecan in combination therapy. Patients with impaired renal function Irinotecan is not recommended for use in patients with impaired renal function, as the product has not been studied in this patient group (see sections 4.4 and 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Elderly No specific pharmacokinetic studies have been conducted in the elderly. However, the dose should be chosen carefully in this patient group due to their greater frequency of decreased biological functions. This population should require more intense surveillance (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Administration Irinotecan solution for infusion should be infused into a peripheral or central vein. Irinotecan should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes.