Irinotel

The agent Irinotecan is a cytostatic and belongs to the therapeutic class of Topoisomerase I inhibitors.

Irinotecan is a derivative of camptothecin. Camptothecins interact specifically with the enzyme topoisomerase I which relieves torsional strain in DNA by inducing reversible single-strand breaks. Irinotecan and its active metabolite SN-38 bind to the topoisomerase I-DNA complex and prevent religation of these single-strand breaks. Current research suggests that the cytotoxicity of irinotecan is due to double-strand DNA damage produced during DNA synthesis when replication enzymes interact with the ternary complex formed by topoisomerase I, DNA, and either irinotecan or SN-38. Mammalian cells cannot efficiently repair these double-strand breaks.

Strength is denoted by disposable cap color.

• Irinotecan Kabi 40 mg/2 ml
• Irinotecan Kabi 100 mg/5 ml

Combination-Agent Dosage Dosage Regimens

Irinotecan Injection in Combination with 5-Fluorouracil (5-FU) and Leucovorin (LV) Irinotecan should be administered as an intravenous infusion over 90 minutes. For all regimens, the dose of LV should be administered immediately after Irinotecan, with the administration of 5-FU to occur immediately after receipt of LV. Irinotecan should be used as recommended.

Single-Agent Dosage Schedules

Dosage Regimens

Irinotecan should be administered as an intravenous infusion over 90 minutes for both the weekly and once-every-3-week dosage schedules. Single-agent dosage regimens

Single-Agent Regimens of Irinotecan and Dose Modifications

Weekly Regimen: 125 mg/m2 IV over 90 min, d 1,8,15,22 then 2-wk rest

Starting Dose & Modified Dose Levelsc (mg/m2)

Starting Dose - 125, Dose Level -1 - 100, Dose Level -2 - 75

Once-Every-3-Week Regimen: 350 mg/m2 IV over 90 min, once every 3 wks

Starting Dose & Modified Dose Levels (mg/m2)

Starting Dose - 350, Dose Level -1 - 300, Dose Level -2 - 250

Irinotecan Injection (Irinotel) is indicated as a component of first line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of colon or rectum. It is also indicated in the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil based therapy.

Strengths:

Irinotecan Kabi 40 mg/2 ml

Irinotecan Kabi 100 mg/5 ml

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory