GNH USA

Europe — EMA

Irinotecan Fresenius Kabi

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

Irinotecan Hydrochloride Trihydrate

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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 is indicated for the treatment of metastatic colorectal cancer and other solid tumours as determined by an oncologist, and may be employed in adjuvant therapy following surgical resection of colon cancer.

GNH USA supplies Irinotecan Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and specialty pharmacies worldwide, with distribution aligned to EU regulatory standards.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is a topoisomerase I inhibitor used in chemotherapy regimens for colorectal and other solid tumours.

Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy. Adjuvant therapy for colon cancer: reduces risk of disease recurrence after curative surgery. Other solid tumours (as determined by oncologist): may be incorporated into combination regimens for selected cancers.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects: - Neutropenia: decreased white blood cell count increasing infection risk. - Diarrhoea: acute onset often within the first two weeks of treatment. - Nausea and vomiting: gastrointestinal upset common during infusion. - Alopecia: hair loss may occur during therapy.

Serious or Rare Side Effects: - Severe neutropenia with fever (febrile neutropenia): life‑threatening infection risk. - Severe diarrhoea (colitis) leading to dehydration and electrolyte imbalance. - Hypersensitivity reactions: anaphylaxis or severe skin rash.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

When using Irinotecan, clinicians should observe specific safety measures to minimise risks.

Assess baseline blood counts: obtain complete blood count before each cycle. Monitor liver function: Irinotecan is metabolised hepatically, adjust for impairment. Genotype UGT1A1 when possible: reduced activity increases SN‑38 exposure. Avoid concurrent myelosuppressive agents unless necessary: may exacerbate bone‑marrow toxicity. Educate patients on early signs of diarrhoea and neutropenia: prompt medical attention required. Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan interacts with several drugs that can alter its efficacy or toxicity.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): markedly reduce SN‑38 formation and therapeutic effect. - UGT1A1 inhibitors (e.g., atazanavir, indinavir): increase SN‑38 levels, raising risk of severe neutropenia and diarrhoea. - Concurrent myelosuppressive chemotherapy (e.g., cyclophosphamide, doxorubicin): additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely): - Anticholinergic agents (e.g., atropine, scopolamine): may worsen irinotecan‑induced diarrhoea. - Warfarin: potential alteration of anticoagulant effect, monitor INR. - Radiation therapy to abdomen/pelvis: may increase gastrointestinal toxicity.

Frequently asked questions

What is Irinotecan Fresenius Kabi used for?+
Irinotecan Fresenius Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer, for adjuvant therapy after surgical resection of colon cancer, and for selected other solid tumours as determined by an oncologist. It is administered as part of combination regimens to improve survival outcomes in these patient populations.
How does Irinotecan Hydrochloride Trihydrate work?+
Irinotecan Hydrochloride Trihydrate is a pro‑drug that is converted in the liver to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I enzyme, stabilising the transient DNA break that the enzyme creates during replication. This prevents DNA re‑ligation, leading to accumulation of DNA damage, cell‑cycle arrest and ultimately tumour cell death.
What is the usual dose of Irinotecan?+
The dosing regimen for Irinotecan is individualized by the treating oncologist based on factors such as the specific cancer type, treatment protocol, patient weight, performance status and organ function. The prescriber determines the appropriate dose, infusion rate and schedule, and may adjust it during therapy according to clinical response and laboratory monitoring.
Is Irinotecan safe in pregnancy or breastfeeding?+
The safety of Irinotecan during pregnancy and lactation has not been established. It is classified as contraindicated for use in pregnant women because of potential fetal toxicity, and breastfeeding is generally discouraged while receiving treatment, as the drug may be excreted in milk and affect the infant.
How do I order Irinotecan Fresenius Kabi from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com specifying the required quantity of Irinotecan Fresenius Kabi. 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 handling) and any necessary import documentation.
How does Irinotecan compare with other topoisomerase I inhibitors?+
Irinotecan and topotecan are both topoisomerase I inhibitors, but Irinotecan is typically used for colorectal and certain other solid tumours, whereas topotecan is more common in small‑cell lung cancer and ovarian cancer. Irinotecan’s pro‑drug conversion to SN‑38 results in a distinct toxicity profile, with higher rates of severe diarrhoea and neutropenia compared with topotecan.
How should Irinotecan be stored and handled?+
Irinotecan injection should be stored at 2‑8 °C in a refrigerator, protected from light. The solution must not be frozen or shaken. Prior to administration, it may be diluted with the appropriate diluent under aseptic conditions and used within the time frame recommended by the manufacturer.
How is Irinotecan administered?+
Irinotecan is given as an intravenous infusion, usually over 30 to 90 minutes depending on the protocol. The drug is supplied as a sterile injection solution that is diluted with a compatible fluid before infusion. Administration is performed in a clinical setting where vital signs and infusion reactions can be monitored.
What are the most serious risks to watch for with Irinotecan?+
The most serious adverse events associated with Irinotecan include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhoea (colitis) that can lead to dehydration and electrolyte imbalance, and hypersensitivity reactions such as anaphylaxis. Prompt recognition and supportive care are essential to mitigate these risks.
Who should not use Irinotecan?+
Irinotecan is contraindicated in patients with known hypersensitivity to the drug or any of its excipients. It should be avoided in individuals with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment without dose adjustment. Caution is also advised for patients with known UGT1A1 deficiency, as they are at higher risk for toxicity.
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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