GNH USA

Europe — EMA

Irinotekan Accord

GNH USA supplies Irinotekan Accord (Irinotecan), a Topoisomerase I inhibitor for colorectal cancer treatment.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotekan Accord, is a Topoisomerase I inhibitor presented as an intravenous formulation for use in cancer therapy. It is employed primarily to treat colorectal cancer in adult patients.

GNH USA supplies Irinotekan Accord as a licensed, GDP‑compliant international pharmaceutical product serving hospitals, oncology centres and pharmacies worldwide, ensuring quality and regulatory compliance across global markets through rigorous quality assurance and adherence to EU standards, and managing the supply chain to meet the needs of diverse clinical settings and support timely patient care.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is a topoisomerase I inhibitor used in the treatment of colorectal cancer.

- Metastatic colorectal cancer: improves survival when combined with fluoropyrimidine‑based regimens. - Colorectal cancer (adjuvant setting): reduces risk of recurrence after surgical resection. - Colorectal cancer (first‑line therapy): administered with leucovorin and 5‑FU as part of the FOLFIRI regimen.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause a range of adverse reactions, some of which are common and others that are serious or rare.

Common Side Effects: - Neutropenia: reduced white blood cell count increasing infection risk. - Diarrhea: may be severe and require supportive care. - Nausea and vomiting: often managed with anti‑emetics. - Fatigue: generalized tiredness during treatment.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophils requiring urgent medical attention. - Severe colitis: intense inflammation of the colon that can be life‑threatening. - Allergic reactions: including rash, bronchospasm, or anaphylaxis. - Hepatotoxicity: elevated liver enzymes indicating liver injury.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Prior to initiating therapy, clinicians should assess patient‑specific factors and monitor for potential complications.

- Monitor blood counts: watch for neutropenia and adjust treatment as needed. - Assess liver function: dose adjustments may be required in hepatic impairment. - Maintain adequate hydration: helps reduce the severity of diarrhea. - Avoid strong CYP3A4 inhibitors: concurrent use can increase irinotecan exposure. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan can interact with other medicines, affecting its safety and efficacy.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise irinotecan plasma levels. - CYP3A4 inducers (e.g., rifampin): can reduce therapeutic effect. - Concurrent myelosuppressive agents: increase risk of severe bone‑marrow suppression.

Moderate Interactions (Monitor Closely): - Warfarin: may enhance anticoagulant effect, requiring INR monitoring. - NSAIDs: can exacerbate gastrointestinal toxicity. - Other antineoplastic drugs: may require dose adjustments and close observation.

Frequently asked questions

What is Irinotekan Accord used for?+
Irinotekan Accord contains irinotecan, a topoisomerase I inhibitor that is primarily used in the management of colorectal cancer, including metastatic and adjuvant settings, often as part of combination chemotherapy regimens.
How does irinotecan work in cancer treatment?+
Irinotecan is converted inside cells to the active metabolite SN‑38, which stabilizes the DNA‑topoisomerase I complex, preventing the re‑ligation of single‑strand DNA breaks. This leads to accumulation of DNA damage, halting tumor cell replication and inducing apoptosis.
What is the usual dose of Irinotekan Accord?+
The dosing regimen for Irinotekan Accord is determined by the prescribing oncologist based on the patient’s clinical condition, treatment protocol, body surface area, and renal and hepatic function. No fixed dose is provided here.
Is Irinotekan Accord safe during pregnancy or breastfeeding?+
Irinotecan is classified as contraindicated in pregnancy because it may cause fetal harm. It is also not recommended during breastfeeding, as it can be excreted in milk and affect the infant. Consultation with a healthcare professional is essential.
How do I order Irinotekan Accord 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 if needed), and import documentation.
How does Irinotekan Accord compare with other colorectal cancer drugs?+
Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from oxaliplatin‑based regimens. It is often used in FOLFIRI protocols and provides an alternative for patients who have progressed on oxaliplatin, though toxicity profiles differ and must be considered when selecting therapy.
What are the storage and handling requirements for Irinotekan Accord?+
Irinotekan Accord should be stored at 2‑8 °C, protected from light, and kept in its original packaging. Do not freeze or shake the product. Follow aseptic techniques during reconstitution and administration to maintain sterility.
How is Irinotekan Accord administered?+
The drug is supplied as an injectable formulation for intravenous infusion. It is typically reconstituted with a suitable diluent and administered over a specified period under medical supervision, following institutional protocols for chemotherapy infusion.
What are the most serious risks associated with Irinotekan Accord?+
The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, and rare but severe allergic reactions. Prompt monitoring and supportive care are essential to manage these potential complications.
Who should not receive Irinotekan Accord?+
Patients with known hypersensitivity to irinotecan or its excipients, those with uncontrolled infections, severe hepatic impairment, or who are pregnant should not receive Irinotekan Accord. The prescribing clinician must evaluate each individual’s suitability.
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
Accord Healthcare Polska Sp. Z O.O.
Origin
EU

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