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, the active ingredient in Irinotecan Accord, is a topoisomerase I inhibitor presented as a sterile injection for intravenous administration. It is employed in the treatment of metastatic colorectal cancer and other advanced solid tumours in adult oncology patients.

GNH India supplies Irinotecan Accord as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, oncology centres, clinics and pharmacies worldwide, supporting oncology therapy across diverse health systems and research institutions.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Irinotecan is a topoisomerase I inhibitor used in specific oncologic indications.

  • Metastatic colorectal cancer: improves survival when combined with fluoropyrimidine‑based regimens.
  • Advanced gastric cancer: may be employed in combination therapy for refractory disease.
  • Advanced pancreatic cancer: used as part of combination regimens in selected patients.

How It Works

  • After intravenous administration, irinotecan is converted by hepatic carboxylesterases to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, preventing relegation of single‑strand breaks during DNA replication. This results in accumulation of DNA damage, inhibition of DNA synthesis, and ultimately cell death in rapidly dividing tumor cells.

Side Effects

Irinotecan may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Diarrhea: may be severe and require prompt management.
  • Nausea and vomiting: common during and after infusion.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Fatigue: persistent tiredness affecting daily activities.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe colitis or intestinal perforation: life‑threatening bowel complications.
  • Hypersensitivity reactions: including anaphylaxis, rash, or bronchospasm.

Precautions & Warnings

When using Irinotecan Accord, clinicians should observe several safety measures to minimize risk.

  • Dose adjustment: consider hepatic or renal impairment before dosing.
  • Monitor blood counts: perform regular CBC to detect neutropenia early.
  • Assess for diarrhea: initiate antidiarrheal therapy at first sign.
  • Avoid strong CYP3A4 inhibitors: may increase exposure to SN‑38.
  • Pregnancy: use only if potential benefit justifies potential risk to fetus.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise SN‑38 levels and toxicity.
  • Anticoagulants (e.g., warfarin): increased risk of bleeding.
  • Live vaccines: immunosuppression may lead to infection.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampin): may reduce drug effectiveness.
  • Other myelosuppressive agents (e.g., carboplatin): additive bone‑marrow suppression.
  • Antidiarrheal agents (e.g., loperamide): may mask early signs of severe diarrhea.

Frequently Asked Questions

Irinotecan Accord contains the chemotherapy agent irinotecan and is indicated for the treatment of metastatic colorectal cancer and for selected advanced solid tumours. It is administered by intravenous infusion under the supervision of an oncologist as part of a combination chemotherapy regimen.

Irinotecan is a pro‑drug that is converted in the body to SN‑38, which binds to the DNA‑topoisomerase I enzyme. By stabilising the enzyme‑DNA complex, SN‑38 prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and tumour cell death.

The dose of Irinotecan Accord is determined individually by the prescribing oncologist based on factors such as the patient’s body surface area, disease stage, prior therapies, and organ function. No fixed dosing schedule is provided here; the prescriber sets the appropriate regimen.

Safety data for Irinotecan in pregnancy and lactation are limited. It is generally contraindicated unless the potential therapeutic benefit outweighs the possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To place an order, submit an enquiry on the Irinotecan Accord product page at gnhindia.com, specifying the required quantity. GNH India 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 necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as oxaliplatin or 5‑fluorouracil that target DNA cross‑linking or thymidylate synthase. Its unique mechanism provides an alternative for patients who have progressed on other regimens, but it also carries distinct toxicity profiles, especially for diarrhea and neutropenia.

Irinotecan Accord should be stored at 2‑8 °C in a refrigerator, protected from light. The product must remain in its original packaging, should not be frozen or shaken, and must be handled using aseptic techniques to maintain sterility until administration.

The medication is supplied as a sterile solution for intravenous infusion. It is typically diluted in an appropriate carrier fluid and infused over a prescribed period, often ranging from 30 minutes to several hours, under close clinical monitoring for infusion‑related reactions.

The most critical adverse events include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea that can progress to colitis or intestinal perforation, and hypersensitivity reactions such as anaphylaxis. Prompt recognition and management of these conditions are essential to reduce morbidity.

Patients with known hypersensitivity to irinotecan or any component of the formulation, those with uncontrolled infections, severe bone‑marrow suppression, or significant hepatic impairment should not receive the drug. Additionally, it is avoided in individuals for whom the risk‑benefit balance is unfavorable, such as certain pregnant women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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