CAMPTO FOR INFUSION 20 mg/ml

INJECTION

**POSOLOGY AND METHOD OF ADMINISTRATION** _Strictly follow the recommended dosage unless directed otherwise by the physician._ Dosage For adults only - In monotherapy (for previously treated patient): The recommended dosage of CAMPTO 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 CAMPTO in combination with 5-fluorouracil (5-FU) and folinic acid (FA) have been assessed with the following schedule: CAMPTO plus 5-FU/FA in every 2 weeks schedule. The recommended dose of CAMPTO 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. Dosage adjustments CAMPTO 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 subsequent infusion of therapy, the dose of CAMPTO, and 5-FU 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 CAMPTO and/or 5-FU when applicable: hematological toxicity (neutropenia Grade 4, febrile neutropenia (neutropenia Grade 3–4 and fever Grade 2–4), thrombocytopenia and leucopenia (Grade 4), non-hematological toxicity (Grade 3–4). Treatment duration Treatment with CAMPTO should be continued until there is an objective progression of the disease or an unacceptable toxicity. Special populations 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 require more intensive surveillance. Patients with impaired hepatic function In monotherapy: in patients with hyperbilirubinemia and prothrombin time 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 CAMPTO is 350 mg/m2. - In patients with bilirubin ranging from 1.5 to 3 times the ULN, the recommended dosage of CAMPTO is 200 mg/m2. - Patients with bilirubin beyond to 3 times the ULN should not be treated with CAMPTO (see **CONTRAINDICATIONS** and **WARNINGS AND PRECAUTIONS** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). No data are available in patients with hepatic impairment treated by CAMPTO in combination. Patients with impaired renal function CAMPTO is not recommended for use in patients with impaired renal function, as studies in this population have not been conducted. Preparation and handling As with other antineoplastic agents, CAMPTO must be prepared and handled with caution. The use of glasses, mask and gloves is required. If CAMPTO solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water. If CAMPTO solution or infusion solution comes into contact with the mucous membranes, wash immediately with water. Preparation for intravenous infusion administration As with any other injectable drugs, the CAMPTO 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 CAMPTO 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 should then be thoroughly mixed by manual rotation. **Administration** CAMPTO solution for infusion should be infused into a peripheral or central vein. CAMPTO should not be delivered as an intravenous bolus or an intravenous infusion shorter than 30 minutes or longer than 90 minutes. **Disposal** All materials used for dilution and administration should be disposed of according to hospital standard procedure applicable to cytotoxic agents.