GNH USA

Europe — EMA

Irinotecan Kabi

GNH USA supplies Irinotecan Kabi (Irinotecan Hydrochloride Trihydrate), a topoisomerase I inhibitor for metastatic colorectal cancer.

Irinotecan Hydrochloride Trihydrate

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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.

Frequently asked questions

What is Irinotecan Kabi used for?+
Irinotecan Kabi is an intravenous anticancer medication indicated for the treatment of metastatic colorectal cancer in adult patients. It is typically administered as part of a combination chemotherapy regimen to improve survival and control tumor growth.
How does Irinotecan Hydrochloride Trihydrate work?+
After infusion, Irinotecan is converted to the active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, causing irreversible DNA damage and leading to cancer cell death.
What is the usual dose of Irinotecan Kabi?+
The specific dose and schedule of Irinotecan Kabi are determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Dosing is individualized and should follow the prescriber’s instructions.
Is Irinotecan Kabi safe during pregnancy or breastfeeding?+
Irinotecan Kabi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is generally not recommended for breastfeeding mothers because the drug can be excreted in breast milk and may harm the infant.
How do I order Irinotecan Kabi from GNH USA?+
To place an order, submit an enquiry on the Irinotecan Kabi product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed), and import documentation.
How does Irinotecan compare with other colorectal cancer drugs?+
Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines (e.g., 5‑FU) and oxaliplatin. It is often combined with these agents to enhance efficacy. Compared with other options, Irinotecan provides a valuable alternative for patients who have progressed on or are unsuitable for other regimens.
What are the storage and handling requirements for Irinotecan Kabi?+
Irinotecan Kabi should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to administration, the solution should be inspected for particulate matter and used within the time frame specified by the manufacturer.
How is Irinotecan Kabi administered?+
Irinotecan Kabi is given as an intravenous infusion, usually over 30 to 90 minutes depending on the protocol. The infusion is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions.
What are the most serious risks associated with Irinotecan Kabi?+
The most serious risks include severe neutropenia leading to infection, life‑threatening diarrhea (enterocolitis), cholinergic syndrome, and rare but severe allergic reactions. Prompt recognition and management of these events are essential to minimize complications.
Who should not receive Irinotecan Kabi?+
Irinotecan Kabi is contraindicated in patients with known hypersensitivity to Irinotecan or any of its excipients, and in individuals with severe hepatic impairment. Caution is also advised for patients with pre‑existing bone‑marrow suppression or uncontrolled infections.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Irinotecan Hydrochloride Trihydrate
Route
Intravenous Use
Manufacturer
Fresenius Kabi Ab
Origin
EU

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