Europe — EMA
Irinotecan Fresenius Kabi (Irinotecan Hydrochloride Trihydrate)
GNH USA supplies Irinotecan Fresenius Kabi (Irinotecan), a topoisomerase inhibitor for colorectal and colon cancer. Request a quote for global supply.
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What is Irinotecan Hydrochloride Trihydrate?
Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Fresenius Kabi, is a topoisomerase I inhibitor presented as an injection solution for intravenous infusion use. It treats metastatic colorectal cancer and is used as adjuvant therapy for colon cancer in adult patients.
GNH USA supplies Irinotecan Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.
What is Irinotecan Hydrochloride Trihydrate used for?
Irinotecan acts on the DNA replication pathway in colorectal malignancies and is employed in several therapeutic settings. - Metastatic colorectal cancer: improves survival when combined with fluoropyrimidine‑based regimens. - Adjuvant therapy for colon cancer: reduces risk of disease recurrence after surgical resection. - Colorectal and colon cancer: used as part of combination chemotherapy protocols for advanced disease.
What are the side effects of Irinotecan Hydrochloride Trihydrate?
Irinotecan is associated with a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: often severe and may require antidiarrheal therapy. - Nausea and vomiting: may be mitigated with anti‑emetics. - Neutropenia: reduced white‑blood‑cell count increasing infection risk. - Alopecia: temporary hair loss. - Fatigue: generalized tiredness. - Anorexia: loss of appetite.
Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count. - Severe colitis or intestinal perforation. - Hepatic toxicity: elevated liver enzymes or jaundice. - Allergic reactions including anaphylaxis. - Severe electrolyte disturbances. - Cardiotoxicity: rare but reported cases of arrhythmia.
What precautions apply to Irinotecan Hydrochloride Trihydrate?
Careful monitoring and dose adjustments are required to minimise toxicity. - Dose adjustment: required for patients with hepatic impairment. - Monitoring: regular CBC and liver‑function tests are recommended. - Pregnancy: contraindicated; classified as Category D, avoid use in pregnant women. - Drug interactions: avoid concurrent strong CYP3A4 inhibitors. - Administration: infusion should be administered over 90 minutes to reduce acute toxicity. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Irinotecan Hydrochloride Trihydrate interact with?
Irinotecan may interact with several drug classes, influencing its efficacy and safety.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): increase SN‑38 exposure. - UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia. - Concurrent use with other topoisomerase I inhibitors: additive cytotoxicity.
Moderate Interactions (Monitor Closely): - Anticoagulants (e.g., warfarin): may enhance bleeding risk. - Nephrotoxic agents (e.g., cisplatin): monitor renal function. - Radiation therapy: may increase gastrointestinal toxicity.



