Product image of Irinotecan Accord (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotecan Accord

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Accord (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Accord, is a topoisomerase I inhibitor presented as an intravenous infusion for intravenous use. It is employed in the treatment of metastatic colorectal cancer and other solid tumours in adult patients. It is indicated for adult patients with advanced disease who have progressed after standard therapies.

GNH India supplies Irinotecan Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, ensuring quality and regulatory compliance across all shipments.

Manufacturer / TM Owner

Accord Healthcare B.V.

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Indications & Clinical Uses

  • Irinotecan is a topoisomerase I inhibitor used in chemotherapy regimens for colorectal and other solid tumours.
  • Metastatic colorectal cancer: provides systemic chemotherapy to shrink tumors and improve survival.
  • Adjuvant colorectal cancer: administered after surgery to reduce the risk of disease recurrence.
  • Other solid tumours: employed in selected cases of gastric, pancreatic or lung cancers when standard options are exhausted.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly by carboxylesterases to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex and stabilises it, preventing re‑ligation of single‑strand DNA breaks during replication. This inhibition leads to accumulation of DNA damage, cell‑cycle arrest and ultimately apoptosis of rapidly dividing cancer cells.

Side Effects

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

Common Side Effects

  • Nausea
  • Diarrhea
  • Neutropenia
  • Fatigue

Serious or Rare Side Effects

  • Febrile neutropenia (severe neutropenia with fever)
  • Life‑threatening colitis (severe diarrhea)
  • Cholinergic syndrome (abdominal cramping, sweating, lacrimation)
  • Hepatic toxicity (elevated liver enzymes)

Precautions & Warnings

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

  • Monitor blood counts: perform regular CBC to detect neutropenia early.
  • Assess liver function: adjust dose in hepatic impairment.
  • Ensure adequate hydration: reduce severity of diarrhea and renal complications.
  • Avoid strong CYP3A4 inhibitors: may increase SN‑38 exposure and toxicity.
  • Pregnancy and lactation: avoid use unless benefits outweigh potential risks, as safety data are lacking.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase SN‑38 levels.
  • UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia.
  • Concurrent myelosuppressive chemotherapy: additive bone‑marrow toxicity.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin): enhanced bleeding risk due to liver enzyme changes.
  • Anticholinergic agents: may exacerbate cholinergic syndrome.
  • Diuretics: can worsen electrolyte imbalances during diarrhea.

Frequently Asked Questions

Irinotecan Accord is an intravenous chemotherapy product containing the active ingredient irinotecan. It is prescribed for adult patients with metastatic colorectal cancer and may be used in other solid tumours where a topoisomerase I inhibitor is indicated, typically as part of a combination regimen.

Irinotecan is a pro‑drug that is metabolised inside cancer cells to SN‑38, which binds to the DNA‑topoisomerase I complex. By stabilising this complex, SN‑38 prevents the re‑ligation of single‑strand DNA breaks, leading to accumulation of DNA damage, cell‑cycle arrest and apoptosis of rapidly dividing tumour cells.

The dose of Irinotecan Accord is determined by the prescribing oncologist based on factors such as the patient’s body surface area, disease stage, prior therapies, liver function and overall health. Dosing regimens are individualized and should follow established clinical guidelines or protocol specifications.

Safety data for irinotecan in pregnancy and lactation are limited. The product is classified as having unknown pregnancy risk, and it is generally avoided unless the potential benefit justifies the potential fetal or neonatal risk. Breastfeeding is also not recommended while receiving treatment.

To order Irinotecan Accord, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams across international markets, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as oxaliplatin (a platinum compound) or 5‑fluorouracil (a pyrimidine analogue). Its unique mechanism targets DNA‑topoisomerase I, offering an alternative pathway for tumour control, especially in patients who have progressed on other regimens.

Irinotecan Accord should be stored at 2‑8 °C in a refrigerator, protected from light and moisture. The product must not be frozen or shaken. Prior to administration, it should be inspected for particulate matter and prepared under aseptic conditions according to the manufacturer’s instructions.

Irinotecan Accord is given as an intravenous infusion, typically over 30 to 90 minutes depending on the protocol. The infusion is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring of vital signs and supportive care measures such as anti‑emetics and hydration.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, cholinergic syndrome, and significant hepatic toxicity. Prompt recognition and management of these events are essential, and patients should be monitored closely during and after infusion.

Irinotecan Accord should be avoided in patients with known hypersensitivity to irinotecan or any of its excipients, in those with severe hepatic impairment, and in individuals who are pregnant or breastfeeding unless the potential benefit outweighs the risk. Caution is also advised for patients with pre‑existing bone‑marrow suppression.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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