Europe — EMA
Irinotecan Kabi (Irinotecan Hydrochloride Trihydrate)
GNH USA supplies Irinotecan Kabi (Irinotecan Hydrochloride Trihydrate), a topoisomerase I inhibitor for metastatic colorectal cancer.
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What is Irinotecan Hydrochloride Trihydrate?
Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Kabi, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous administration. It is indicated for the treatment of metastatic colorectal cancer in adult patients.
GNH USA supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide, with distribution aligned to EU regulatory standards. The product meets stringent quality specifications and is manufactured under GMP conditions for global clinical use, ensuring consistent potency and safety across markets.
What is Irinotecan Hydrochloride Trihydrate used for?
Irinotecan Kabi is a topoisomerase I inhibitor used in colorectal cancer therapy.
Metastatic colorectal cancer: used as part of combination chemotherapy to extend survival and control disease progression. Advanced unresectable colorectal adenocarcinoma: provides tumor shrinkage when combined with other agents, facilitating potential surgical resection.
What are the side effects of Irinotecan Hydrochloride Trihydrate?
Irinotecan Kabi may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Diarrhea: often delayed and may be severe. - Neutropenia: reduced white blood cell count. - Nausea and vomiting. - Alopecia: hair loss. - Fatigue and weakness. - Abdominal pain or cramping.
Serious or Rare Side Effects: - Febrile neutropenia: infection with fever. - Severe or life‑threatening diarrhea (enterocolitis). - Cholinergic syndrome: sweating, salivation, bronchospasm. - Anaphylactic or severe allergic reactions. - Hepatotoxicity: elevated liver enzymes. - Bone marrow failure leading to pancytopenia.
What precautions apply to Irinotecan Hydrochloride Trihydrate?
Before initiating therapy, clinicians should evaluate patient‑specific factors and monitor for toxicity.
Dose adjustment: assess hepatic function and adjust dose accordingly. Monitor blood counts: perform regular complete blood counts to detect neutropenia. Hydration: ensure adequate fluid intake to mitigate risk of severe diarrhea. Avoid strong CYP3A4 inhibitors: concomitant use may increase irinotecan exposure. Pregnancy: prescribe only when potential benefit justifies potential risk to the fetus. 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 other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): increase toxicity – avoid co‑administration. - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): reduce efficacy – avoid co‑administration. - Concurrent myelosuppressive agents (e.g., cyclophosphamide): heightened bone‑marrow suppression – avoid.
Moderate Interactions (Monitor Closely): - Warfarin: monitor INR as bleeding risk may increase. - Anticholinergic drugs (e.g., atropine): may exacerbate cholinergic syndrome – monitor. - Fluoropyrimidines (e.g., 5‑FU): increased gastrointestinal toxicity – monitor closely.



