📋 Indications & Clinical Dosage
*Metastatic colorectal cancer in combination with fluorouracil and folinic acid or as monotherapy when treatment containing fluorouracil has failed, Treatmentof epidermal growth factor receptor-expressing metastatic colorectal cancer after failure of chemotherapy that has included irinotecan (in combination with cetuximab), First-line treatment of metastatic carcinoma of the colon or rectum (in combination with fluorouracil, folinic acid and bevacizumab or capecitabine with or without bevacizumab):*
BY IV INF: Adult: 350 mg/m2 over 30-90 min every 3 week. If patient develops severe neutropenia or severe diarrhoea reduce dose to 300 mg/m, and then 250 mg/m, in subsequent cycles. Consult product literature. Continue treatment until disease progression or unacceptable toxicity. Children: Not recommended.
💊 Mode of Administration
Administer by IV Infusion, usually over 90 min. D5W (500 ml) is the preferred diluent for most doses. Solutions diluted in NS may precipitate if refrigerated. Dilute in D5W or NS to a final cons of 0.122.8 mg/ml. Due to the relatively acidic pH, irinotecan appears to be more stable in D5W than NS, D5W (500 ml) is the preferred diluent for most doses.
⛔ Contraindications
Chronic inflammatory bowel disease, bowel obstruction, hepatic impairment, renal impairment, severe myelosuppression.
🔄 Drug Interactions
Neuromuscular blocking agents, carbamazepine, phenobarbital, phenytoin, ketoconazole
⚠️ Adverse Reactions / Side Effects
Interstitial pulmonary disease, acute cholinergic syndrome and delayed diarrhoea (consult product literature), alopecia, anorexia, asthenia, bone-marrow suppression, extravasation, GI effects, hyperuricaemia, myelosuppression(dose limiting), nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Positive evidence of risk: Avoid
Lactation / Breastfeeding:
Contraindicated. Discontinue breast-feeding
🧪 Compatibility & Storage Stability
Compatibility: Stable in 135W, NS
Stability & Storage: Store vials at 15C-30C (59F-86F). Protect from light. Vials should remain in carton until the time of use. The diluted solution is physically and chemically stable for up to 24 hours at room temperature (approximately 25C) and in ambient fluorescent lighting. In the case of admixtures pre-pared with D5W or NaCI, the solutions should be used within 6 hours if kept at room temperature 15C-30C (59F-86F). Solutions diluted in D5W and stored at refrigerated temperatures 2C-8C (36F-46F) and protected from light are physically and chemically
stable for 48 hours; however it is advisable to use them within 24 hours. Refrigeration of admixtures using 0.9% NaCI is not recommended.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.