Irinotel Dosage/Direction for Use

Premedication with antiemetics: Since irinotecan is emetogenic agent, it is recommended that patients receive premedication with antiemetic agents. In clinical studies, the majority of patients received 10 mg of dexamethasone given in conjunction with another type of antiemetic agent, such as a 5-HT3 blocker (eg, ondansetron or granisetron). Antiemetic agents should be given on the day of treatment, starting at least 30 minutes before administration of irinotecan.
Dosage and administration: Irinotecan should be administered as intravenous infusion over 30 to 90 minutes for all doses.
Single‑agent dosage regimen: Weekly dosage regimen: Irinotecan dose is 125 mg/m². A lower starting dose may be considered (e.g. 100 mg/m²) for patients with any of the following conditions prior extensive radiotherapy, performance status of 2, increased bilirubin levels, or gastric cancer. Treatment should be given in repeated 6‑week cycles comprising weekly treatment for 4 weeks, followed by a 2‑week rest.
Once‑every‑2‑week dosage regimen: Irinotecan dose is 250 mg/m² every 2 weeks by intravenous infusion. A lower starting dose may be considered (e.g., 200 mg/m²) 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.
Once‑every‑3‑week dosage regimen: Irinotecan for the once‑every‑3‑week dose is 350 mg/m². A lower starting dose may be considered (e.g., 300 mg/m²) 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.
Combination‑agent dosage schedules: Irinotecan combine with 5‑fluorouracil (5‑FU) and Leucovorin: Irinotecan in combination with 5‑FU and leucovorin is recommended for the treatment of metastatic colorectal cancer. The recommended dose is 125 mg/m² of irinotecan, 500 mg/m² of 5‑FU, and 20 mg/m² of leucovorin. Lower starting doses may be considered for irinotecan (e.g., 100 mg/m²) and 5‑FU (e.g. 400 mg/m²) 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 weekly treatment for 4 weeks, followed by a 2‑week rest.
Irinotecan in combination with Cetuximab: For dosage & administration of concomitant cetuximab, refer to the full prescribing information of cetuximab. 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.
Irinotecan in combination with Bevacizumab: For dosage & administration of bevacizumab, refer to the full prescribing information of bevacizumab. Bevacizumab is recommended in combination with irinotecan (125 mg/m²) /bolus 5‑FU (500 mg/m²) folinic acid (20 mg/m²) given once weekly for 4 weeks every 6 weeks. 
Irinotecan in combination with Cisplatin: Irinotecan in combination with cisplatin has been studied for non‑small cell and small cell lung cancer, cervical cancer, gastric cancer, and esophageal cancer. This regimen may be used in the treatment of patients with over indicated cancers, except for colorectal cancer (see Indications).
The recommended dose is 65 mg/m² of irinotecan and 30 mg/m² of cisplatin. A lower dose of irinotecan (e.g., 50 mg/m²) 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 weekly treatment for 4 weeks, followed by a 2‑week rest.
Delayed Dosing: IRINOTEL should not be administered until the neutrophil count returns to more than 1500 cells/mm³. In patients who experienced severe neutropenia or severe gastrointestinal adverse events, e.g. diarrhea, nausea and vomiting, dosing of IRINOTEL should be delayed until there has been a full recovery of these symptoms, especially diarrhea.
Duration of Treatment: Treatment with IRINOTEL should be continued until there is an objective progression of the disease or an unacceptable toxicity.
In patients with a bilirubin more than 3 times the ULN, patients should not be treated with IRINOTEL.
Patients with Impaired Renal Function: IRINOTEL 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 the elderly. However, the dose should be chosen carefully in this population due to their greater frequency of decreased biological functions, in particular hepatic function. This population therefore requires more intensive surveillance.