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

Irinotecan Hcl-Trihydraat Accord

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Hcl-Trihydraat Accord (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Hcl-Trihydraat Accord, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous administration. It is used in the treatment of metastatic colorectal cancer, primarily in adult patients who require systemic chemotherapy.

GNH India supplies Irinotecan Hcl-Trihydraat Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The product complies with EU pharmaceutical standards and is manufactured under GMP conditions. It is distributed through a secure cold‑chain logistics network to ensure product integrity during transport.

Manufacturer / TM Owner

Accord Healthcare B.V.

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Indications & Clinical Uses

  • Irinotecan is a topoisomerase I inhibitor used in the management of colorectal cancer.
  • Metastatic colorectal cancer: improves survival when used in combination chemotherapy regimens.
  • Refractory colorectal cancer: provides an option after progression on first‑line therapies.
  • Colorectal cancer in combination therapy: contributes to tumor response as part of the FOLFIRI regimen.

How It Works

  • Irinotecan Hydrochloride Trihydrate is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This binding prevents the religation step of DNA replication, leading to accumulation of DNA breaks, inhibition of DNA synthesis, and ultimately tumor cell death.

Side Effects

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

Common Side Effects

  • Nausea and vomiting
  • Diarrhea (often delayed)
  • Neutropenia
  • Fatigue
  • Alopecia
  • Abdominal pain

Serious or Rare Side Effects

  • Severe neutropenia or febrile neutropenia
  • Life‑threatening diarrhea or colitis
  • Hepatic toxicity (elevated transaminases)
  • Severe allergic reactions (anaphylaxis)
  • Pulmonary toxicity (interstitial pneumonitis)

Precautions & Warnings

  • When using Irinotecan, clinicians should observe several safety measures.
  • Dose adjustment: required in patients with hepatic impairment.
  • Monitoring: regular blood counts to detect neutropenia.
  • Hydration: maintain adequate fluids to reduce risk of severe diarrhea.
  • Drug interactions: avoid concurrent strong CYP3A4 inhibitors.
  • Pregnancy: use only if potential benefit justifies risk; data are limited.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Irinotecan interacts with several medicines; awareness of the interaction level guides clinical decisions.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: may increase irinotecan exposure.
  • UGT1A1 inhibitors: can raise active metabolite levels.
  • Concurrent use with other myelosuppressive agents: risk of severe bone marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: may increase bleeding risk.
  • Diuretics: may affect electrolyte balance.
  • Radiation therapy: may enhance toxicity.

Frequently Asked Questions

Irinotecan Hcl‑Trihydraat Accord is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer in adult patients. It is typically used as part of combination regimens such as FOLFIRI to improve tumor response and overall survival.

The drug is a pro‑drug that is converted inside cancer cells to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, preventing DNA religation during replication, which leads to DNA strand breaks, inhibition of cell division, and tumor cell death.

The dosing regimen is individualized by the prescribing oncologist based on factors such as the patient’s body surface area, liver function, prior treatment history, and overall clinical condition. No fixed dose can be provided without a medical assessment.

Safety data for Irinotecan in pregnancy and lactation are limited. It should only be used when the potential therapeutic benefit justifies the potential risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com with 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 import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class and is often used after or in combination with fluoropyrimidines and oxaliplatin. Compared with agents like oxaliplatin, Irinotecan has a distinct toxicity profile, featuring more pronounced diarrhea and neutropenia, but offers an effective alternative for patients who progress on other regimens.

The product should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen. Prior to administration, the solution should be inspected for particulate matter and used within the time frame specified by the manufacturer.

Irinotecan is given as an intravenous infusion, usually over 30 to 90 minutes depending on the protocol. The infusion is performed by qualified healthcare personnel in a clinical setting, with appropriate monitoring for infusion‑related reactions and vital signs.

The most critical adverse events include severe neutropenia (which can lead to infection), life‑threatening diarrhea or colitis, hepatic toxicity, and rare allergic reactions. Prompt recognition and supportive care are essential to mitigate these risks.

Patients with known hypersensitivity to Irinotecan or any of its excipients, those with severe hepatic impairment, and individuals with uncontrolled infections or active severe bone‑marrow suppression should not be treated with Irinotecan. Clinical judgment is required for all other cases.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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