Zinotecan

A light yellow-coloured solution, free from visible particles.

Irinotecan is used alone or in combination with other medications to treat colon or rectal cancer (cancer that begins in the large intestine).

Irinotecan is in a class of antineoplastic medications.

It works by stopping the growth of cancer cells.

The molecular formula of irinotecan hydrochloride is

C₃₃H₃₈N₄O₆.HCl.3H₂O

Its molecular weight is 677.18 g/mol.

ZINOTECAN Injection is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum.

Irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.

Patients should be carefully monitored for toxicity, and doses of irinotecan should be modified as necessary to accommodate individual patient tolerance to treatment.

Recommended Dose Modifications For Single-Agent Schedules

All dose modifications should be based on the worst preceding toxicity.

A new cycle of therapy should not begin until the toxicity has recovered to NCI Grade 1 or less.

Treatment may be delayed 1 to 2 weeks to allow for recovery from treatment-related toxicity.

If the patient has not recovered, consideration should be given to discontinuing this combination therapy.

Provided intolerable toxicity does not develop, treatment with additional cycles of irinotecan may be continued indefinitely as long as patients continue to experience clinical benefit.

Dosage In Patients With Reduced UGT1A1 Activity

When administered in combination with other agents, or as a single agent, a reduction in the starting dose by at least one level of irinotecan should be considered for patients known to be homozygous for the UGT1A1*28 allele.

However, the precise dose reduction in this patient population is not known, and subsequent dose modifications should be considered based on individual patient tolerance to treatment.

• Read the label carefully before use.

• Keep out of the reach of children.

Colorectal Cancer Combination Regimen 1

• ZINOTECAN 125 mg/m² intravenous infusion over 90 minutes on Days 1, 8, 15 and 22

with

• Leucovorin (LV) 20 mg/m² intravenous bolus infusion on Days 1, 8, 15 and 22

followed by

• 5-Fluorouracil (5-FU) intravenous bolus infusion on Days 1, 8, 15 and 22

every 6 weeks.

Colorectal Cancer Combination Regimen 2

• ZINOTECAN 180 mg/m² intravenous infusion over 90 minutes on Days 1, 15 and 29

with

• Leucovorin (LV) 200 mg/m² intravenous infusion over 2 hours on Days 1, 2, 15, 16, 29 and 30

followed by

• 5-FU 400 mg/m² intravenous bolus infusion on Days 1, 2, 15, 16, 29 and 30

and

• 5-FU 600 mg/m² intravenous infusion over 22 hours on Days 1, 2, 15, 16, 29 and 30.

Colorectal Cancer Single-Agent Regimen 1

• ZINOTECAN 125 mg/m² intravenous infusion over 90 minutes on Days 1, 8, 15 and 22

followed by

• A 2-week rest period.

Colorectal Cancer Single-Agent Regimen 2

• ZINOTECAN 350 mg/m² intravenous infusion over 90 minutes on Day 1 every 3 weeks.