IRINOTEL INJECTION 20 MG/ML [SIN16266P]

Product Info

IRINOTEL INJECTION 20 MG/ML

[SIN16266P]

INDICATIONS
Irinotecan is indicated for the treatment of patients with advanced colorectal cancer:

• In combination with 5-flurouracil and folinic acid in patients without prior chemotherapy for advanced disease.

• As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.

DOSAGE AND 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 irinotecan 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 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.

  
  

Dosage adjustments
Irinotecan 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 irinotecan, 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 irinotecan 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 irinotecan 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 hematoxicity 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 irinotecan is 350 mg/m².

• In patients with bilirubin ranging from 1.5 to 3 times the ULN, the recommended dosage of irinotecan is 200 mg/m².

• Patients with bilirubin beyond to 3 times the ULN should not be treated with irinotecan).

No data are available in patients with hepatic impairment treated by irinotecan in combination.

Patients with impaired renal function:
Irinotecan 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, irinotecan must be prepared and handled with caution. The use of glasses, mask and gloves is required. If irinotecan solution or infusion solution should come into contact with skin, wash immediately and thoroughly with soap and water.

If irinotecan solution or infusion solution comes into contact with the mucous membranes, wash immediately with water.

Preparation for intravenous infusion administration:
Inspect vial contents for particulate matter and discoloration and repeat inspection when drug product is withdrawn from vial into syringe. Irinotecan Injection 20 mg/ml is intended for single use only and any unused portion should be discarded.

Irinotecan Injection must be diluted prior to infusion. Irinotecan Injection should be diluted in 5 % Dextrose Injection, (preferred) or 0.9 % Sodium Chloride Injection, to a final concentration range of 0.12 mg/ml to 2.8 mg/ml. Other drugs should not be added to the infusion solution.

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.

CONTRAINDICATIONS
Irinotecan is contraindicated in patients with:

• A chronic inflammatory bowel disease and/or a bowel obstruction (see PRECAUTIONS AND WARNINGS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• A history of severe hypersensitivity reactions to irinotecan hydrochloride trihydrate or to one of the excipients of Irinotecan.

• In pregnant or breast-feeding women.

• In patients with bilirubin >3 times the ULN (see PRECAUTIONS AND WARNINGS – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

• In patients with a severe bone marrow failure.

• In patients presenting a risk factor, particularly those with a WHO performance status >2.