GNH USA

Europe — EMA

Irinotecan Accord

GNH USA supplies Irinotecan Accord (Irinotecan), a Topoisomerase I inhibitor for metastatic colorectal cancer and adjuvant colon cancer therapy.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Accord, is a Topoisomerase I inhibitor presented as an injection solution for intravenous use. It is used in the treatment of metastatic colorectal cancer and as adjuvant therapy for colon cancer in adult patients.

GNH USA supplies Irinotecan Accord as a licensed, GDP-compliant international pharmaceutical supplier serving oncology centres worldwide.

What is Irinotecan Hydrochloride Trihydrate used for?

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

- Metastatic colorectal cancer: improves disease control and overall survival when combined with standard chemotherapy regimens. - Adjuvant therapy for colon cancer: reduces risk of recurrence after surgical resection in patients with high‑risk disease.

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 delayed and may be severe. - Neutropenia: reduced white blood cell count increasing infection risk. - Nausea and vomiting: typical chemotherapy‑related symptoms. - Fatigue: generalized tiredness during treatment cycles. - Alopecia: hair thinning or loss. - Anorexia: decreased appetite.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count requiring urgent care. - Severe colitis: life‑threatening intestinal inflammation. - Cholinergic syndrome: abdominal cramping, sweating, and bradycardia. - Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis. - Hepatic dysfunction: elevated liver enzymes or jaundice. - Thromboembolic events: rare clot formation in veins or arteries.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Before initiating therapy, clinicians should assess patient suitability and monitor for potential complications.

- Hematology monitoring: perform baseline and periodic complete blood counts. - Liver function assessment: evaluate hepatic enzymes and bilirubin before each cycle. - Dose adjustment: modify dosing in patients with moderate hepatic impairment. - Diarrhea management: implement prophylactic antidiarrheal measures and educate patients on early reporting. - Pregnancy and lactation: avoid use unless benefits outweigh potential risks; consult obstetric specialist. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the vial.

What does Irinotecan Hydrochloride Trihydrate interact with?

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

Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce SN‑38 exposure and therapeutic effect. - UGT1A1 inhibitors (e.g., atazanavir, indinavir): increase SN‑38 levels, raising toxicity risk. - Concurrent myelosuppressive agents: amplify risk of severe neutropenia and infection.

Moderate Interactions (Monitor Closely): - Anticoagulants (e.g., warfarin): enhanced bleeding risk due to mucosal injury. - Anticholinergic drugs: may exacerbate cholinergic syndrome symptoms. - Other anti‑diarrheal agents: adjust dosing to avoid excessive constipation or ileus.

Frequently asked questions

What is Irinotecan Accord used for?+
Irinotecan Accord is an intravenous formulation of irinotecan hydrochloride tri­hydrate indicated for the treatment of metastatic colorectal cancer and as adjuvant therapy after surgical resection of colon cancer in adult patients.
How does Irinotecan 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 DNA damage, cell‑cycle arrest, and ultimately tumor cell death.
What is the usual dose of Irinotecan Accord?+
The dose of Irinotecan Accord is individualized by the prescribing oncologist based on factors such as cancer type, disease stage, patient weight, liver function, and prior treatment history. Exact dosing regimens are determined by the treating physician.
Is Irinotecan safe during pregnancy or breastfeeding?+
Safety data for irinotecan in pregnancy and lactation are limited. It is generally avoided unless the potential benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.
How do I order Irinotecan Accord from GNH USA?+
To place an order, submit an enquiry on the Irinotecan Accord 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 required import documentation.
How does Irinotecan compare with other colorectal cancer drugs?+
Irinotecan belongs to the topoisomerase I inhibitor class, offering a mechanism distinct from fluoropyrimidines (e.g., 5‑FU) or oxaliplatin. It is often combined with these agents to enhance response rates. Compared with other topoisomerase inhibitors, irinotecan’s toxicity profile is characterized by delayed diarrhea and neutropenia, requiring specific supportive care.
How should Irinotecan Accord be stored and handled?+
Irinotecan Accord should be stored refrigerated at 2‑8 °C, protected from light, and never frozen. The vial must be kept in its original packaging until use and should be gently inverted to mix if required; shaking is not recommended.
How is Irinotecan administered?+
Irinotecan Accord is administered by intravenous infusion, typically over 30‑90 minutes depending on the regimen. The infusion is performed in a clinical setting by qualified healthcare professionals, with monitoring for infusion‑related reactions and supportive measures for anticipated side effects.
What are the most serious risks to watch for with Irinotecan?+
The most serious risks include severe neutropenia leading to infection, life‑threatening delayed diarrhea or colitis, febrile neutropenia, cholinergic syndrome, and rare hypersensitivity reactions. Prompt recognition and management of these events are essential to minimize morbidity.
Who should not use Irinotecan?+
Irinotecan is contraindicated in patients with known severe hypersensitivity to the drug, those with uncontrolled infections, and individuals with severe hepatic impairment (e.g., bilirubin >1.5 ×  ULN). Caution is also advised for patients with pre‑existing gastrointestinal disorders that could exacerbate diarrhea.
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 B.V.
Origin
EU

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