Irita 20 mg/ml (IV Infusion)

Indications

• First-line therapy in combination with 5-Fluorouracil (5-FU) and Leucovorin (LV) for metastatic carcinoma of the colon or rectum
• For patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial Fluorouracil-based therapy

Pharmacology

• Derivative of Camptothecin
• Interacts with the enzyme topoisomerase I
• Binds to the topoisomerase I-DNA complex and prevents religation of single-strand breaks

Dosage & Administration

• Colorectal cancer combination regimen 1: Irinotecan 125 mg/m^2 intravenous infusion over 90 minutes on days 1, 8,15, 22 with LV 20 mg/m^2 intravenous bolus infusion on days 1, 8, 15, 22 followed by 5-FU intravenous bolus infusion on days 1, 8, 15, 22 every 6 weeks
• Colorectal cancer combination regimen 2: Irinotecan 180 mg/m2 intravenous infusion over 90 minutes on days 1, 15, 29 with LV 200 mg/m^2 intravenous infusion over 2 hours on days 1, 2, 15, 16, 29, 30 followed by 5-FU 400 mg/m 2 intravenous bolus infusion on days 1, 2, 15, 16, 29, 30 and 5-FU 600 mg/m 2 intravenous infusion over 22 hours on days 1, 2, 15, 16, 29, 30
• Colorectal cancer single agent regimen 1: Irinotecan 125 mg/m^2 intravenous infusion over 90 minutes on days 1, 8, 15, 22 then 2-week rest
• Colorectal cancer single agent regimen 2: Irinotecan 350 mg/m^2 intravenous infusion over 90 minutes on day 1 every 3 weeks

Interaction

• Diuretics increase risks of dehydration
• Prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia
• Prochlorperazine may increase incidence of akathisia
• St John's wort and ketoconazole may reduce irinotecan exposure

Contraindications

• Known hypersensitivity to the drug or its excipients

Side Effects

• Nausea
• vomiting
• abdominal pain
• diarrhea
• constipation
• anorexia
• mucositis
• neutropenia
• leukopenia
• anemia
• thrombocytopenia
• asthenia
• pain
• fever
• infection
• abnormal bilirubin
• alopecia

Pregnancy & Lactation

• Pregnancy category D
• Can cause fetal harm when administered to a pregnant woman
• Excretion in human male is not known

Precautions & Warnings

• Diarrhea and cholinergic reactions
• Myelosuppression
• Patients with Reduced UGT1A1 Activity
• Use caution in elderly patients
• Use caution in patients with renal impairment
• Use caution in patients with hepatic impairment

Use in Special Populations

• Effectiveness in pediatric patients not established
• Greater risk of early and late diarrhea in patients >65 years
• Caution in patients with impaired renal function
• Not recommended for use in patients on dialysis
• Diminished clearance in patients with hepatic impairment

Therapeutic Class

• Cytotoxic Chemotherapy

Storage Conditions

• Store at controlled room temperature 15°C to 30°C
• Protect from light
• Keep the vial in the carton until the time of use

Related Brands

• Irinacan 20 mg/ml (IV Infusion) - renata-limited
• Irotecan 20 mg/ml (IV Infusion) - healthcare-pharmaceuticals-ltd