GNH USA

Europe — EMA

Irinotecan Hcl-Trihydraat Fresenius Kabi

GNH USA supplies Irinotecan (Irinotecan), a topoisomerase I inhibitor for metastatic and adjuvant colorectal cancer.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan, the active ingredient in Irinotecan Hcl-Trihydraat Fresenius Kabi, is a topoisomerase I inhibitor presented as an injectable solution for intravenous use. It treats metastatic and advanced colorectal cancer, including adjuvant therapy, in adult patients.

GNH USA supplies Irinotecan Hcl-Trihydraat 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 is a topoisomerase I inhibitor used in colorectal cancer treatment pathways.

Metastatic colorectal cancer: improves overall survival when combined with standard chemotherapy regimens. Advanced colorectal cancer: provides disease control for patients with unresectable disease. Adjuvant therapy for colorectal cancer: reduces the risk of recurrence after surgical resection.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause 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 managed with antiemetics. - Neutropenia: reduced white blood cell count increasing infection risk. - Alopecia: temporary hair loss during treatment. - Fatigue: generalized tiredness affecting daily activities. - Abdominal pain: discomfort in the stomach area.

Serious or Rare Side Effects: - Severe neutropenic infection: febrile neutropenia requiring immediate medical attention. - Life‑threatening diarrhea: may lead to dehydration and electrolyte imbalance. - Hepatotoxicity: liver enzyme elevations indicating potential liver injury.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Before initiating therapy, clinicians should assess patient suitability and monitor for known risks.

Baseline blood counts: obtain complete blood count to detect pre‑existing neutropenia. Liver function: evaluate hepatic enzymes as impaired function can increase toxicity. Renal function: adjust monitoring in patients with reduced clearance. Pregnancy and lactation: avoid use due to unknown safety profile; discuss alternatives. Drug interactions: review concomitant medications for potential CYP3A4 modulators. Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake the solution.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan interacts with several agents that can modify its efficacy or toxicity.

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce SN‑38 exposure. - Potent CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): can increase SN‑38 levels and risk of severe toxicity. - UGT1A1 inhibitors (e.g., atazanavir): may impair SN‑38 glucuronidation, raising toxicity.

Moderate Interactions (Monitor Closely): - Anticoagulants (e.g., warfarin): increased bleeding risk due to platelet suppression. - Other myelosuppressive agents: additive bone‑marrow depression. - Antidiarrheal agents (e.g., loperamide): may mask early signs of severe diarrhea. - Granulocyte colony‑stimulating factors: may reduce neutropenia duration. - Herbal supplements (e.g., St. John’s wort): potential CYP3A4 induction.

Frequently asked questions

What is Irinotecan Hcl‑Trihydraat Fresenius Kabi used for?+
Irinotecan Hcl‑Trihydraat Fresenius Kabi is an injectable chemotherapy agent indicated for the treatment of metastatic and advanced colorectal cancer, as well as for adjuvant therapy after surgical resection of colorectal tumors. It is used in adult patients as part of combination regimens to improve survival outcomes.
How does Irinotecan work in the body?+
Irinotecan is a prodrug that is metabolized to SN‑38, which inhibits the enzyme topoisomerase I. This inhibition prevents the religation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately causing cancer cell death.
What is the usual dose of Irinotecan?+
The specific dose of Irinotecan Hcl‑Trihydraat Fresenius Kabi is determined by the prescribing oncologist based on factors such as patient weight, disease stage, and treatment protocol. Dosing regimens are individualized and should follow the prescriber’s instructions and local guidelines.
Is Irinotecan safe during pregnancy or breastfeeding?+
The safety of Irinotecan in pregnancy and lactation has not been established. It is generally contraindicated in pregnant or nursing women because of potential fetal toxicity and unknown effects on the infant. Alternative therapies should be considered in these populations.
How do I order Irinotecan Hcl‑Trihydraat Fresenius Kabi from GNH USA?+
To place an order, submit an enquiry on the 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 handling 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 or 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, though toxicity profiles differ.
What are the storage and handling requirements for Irinotecan?+
Irinotecan Hcl‑Trihydraat Fresenius Kabi should be stored at 2‑8 °C in a refrigerator, protected from light. The solution must not be frozen or shaken. Prior to administration, inspect the vial for particulate matter and ensure the correct reconstitution procedures are followed.
How is Irinotecan administered to patients?+
Irinotecan is given as an intravenous infusion, typically over 30 to 90 minutes depending on the protocol. Administration is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions and supportive care measures.
What are the most serious risks associated with Irinotecan therapy?+
The most serious risks include severe neutropenia leading to infection, life‑threatening diarrhea that can cause dehydration and electrolyte imbalance, and hepatic toxicity. Prompt recognition and management of these events are essential, and patients should be educated on early symptom reporting.
Who should not receive Irinotecan?+
Irinotecan is contraindicated in patients with known hypersensitivity to the drug or its excipients, those with severe uncontrolled infections, and individuals with significant hepatic impairment that cannot be adequately managed. Caution is also advised for patients with pre‑existing bone‑marrow suppression.
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 Nederland B.V.
Origin
EU

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