Irotecan 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
• Treatment 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 specifically with the enzyme topoisomerase I
• Prevents religation of single-strand DNA breaks

Dosage & Administration

• Colorectal cancer combination regimen 1: Irinotecan 125 mg/m^2 intravenous infusion 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 every 6 weeks
• Colorectal cancer single agent regimen 2: Irinotecan 350 mg/m^2 intravenous infusion on day 1 every 3 weeks

Interaction

• Increased risks of dehydration with diuretics
• Prophylactic dexamethasone as an antiemetic may enhance lymphocytopenia
• St. John's wort, 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

Precautions & Warnings

• Early diarrhea may be accompanied by cholinergic symptoms
• Late diarrhea can be life threatening
• Deaths due to sepsis following severe neutropenia reported
• Patients with reduced UGT1A1 activity are at increased risk for neutropenia
• Pediatric use not established
• Geriatric patients >65 years have greater risk of early and late diarrhea
• Use caution in patients with impaired renal function
• Irinotecan clearance is diminished in patients with hepatic impairment

Use in Special Populations

• Pediatric use effectiveness not established
• Geriatric patients >65 years should be closely monitored
• Use caution in patients with impaired renal function
• Irinotecan is not recommended for use in patients on dialysis
• Irinotecan clearance is diminished in patients with hepatic impairment
• Exposure to the active metabolite SN-38 is increased 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