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 solution for injection for intravenous use. It treats metastatic colorectal cancer and is used as adjuvant therapy in colorectal cancer patients.

GNH India supplies Irinotecan Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Accord Healthcare B.V.

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Indications & Clinical Uses

Irinotecan Accord is a topoisomerase I inhibitor indicated for colorectal cancer treatment pathways.

  • Metastatic colorectal cancer: improves overall survival and disease control.
  • Adjuvant treatment of colorectal cancer: reduces risk of postoperative recurrence.
  • Colorectal cancer combination therapy: used with other agents to enhance tumor response.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex and stabilizes it. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately cell death in rapidly dividing tumor cells.

Side Effects

Irinotecan Accord may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhea: often severe and may require supportive care.
  • Nausea and vomiting: may be mitigated with anti‑emetics.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: hair loss during treatment cycles.
  • Fatigue: generalized tiredness.
  • Abdominal pain: discomfort in the gastrointestinal tract.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent treatment.
  • Severe colitis: life‑threatening diarrhea with possible dehydration.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Cardiac toxicity: rare arrhythmias or myocardial ischemia.
  • Secondary malignancies: very rare risk of therapy‑related cancers.

Precautions & Warnings

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

  • Pregnancy: Category D – avoid use unless potential benefits justify the risk.
  • Renal impairment: assess kidney function and adjust dose as needed.
  • Hepatic impairment: monitor liver enzymes and consider dose modification.
  • Myelosuppression: perform regular complete blood counts to detect neutropenia.
  • Drug interactions: avoid concurrent strong CYP3A4 inhibitors that may increase exposure.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with other medicines, altering its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase SN‑38 levels.
  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effect.
  • Other topoisomerase I inhibitors: additive toxicity risk.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole): may modestly raise exposure.
  • Anticoagulants (e.g., warfarin): monitor INR for bleeding risk.
  • Concurrent myelosuppressive agents: increase risk of severe neutropenia.

Frequently Asked Questions

Irinotecan Accord is indicated for the treatment of metastatic colorectal cancer and as an adjuvant therapy after surgical resection of colorectal tumors. It is used to improve survival outcomes and reduce the risk of disease recurrence in adult patients.

Irinotecan is a pro‑drug that is converted to SN‑38 inside cells. SN‑38 binds to the DNA‑topoisomerase I complex, preventing the re‑ligation of single‑strand DNA breaks during replication. This leads to accumulation of DNA damage and triggers apoptosis in rapidly dividing cancer cells.

The dose of Irinotecan Accord is individualized by the prescribing oncologist based on factors such as body surface area, disease stage, prior therapies, and organ function. Only a qualified healthcare professional should determine the appropriate regimen.

Irinotecan is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should be avoided during pregnancy unless the potential benefit justifies the risk. Use during breastfeeding is not recommended because the drug may be excreted in milk.

To request Irinotecan Accord, submit an enquiry on the 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 where applicable) and necessary import documentation.

The primary alternative within the same class is topotecan, another topoisomerase I inhibitor. Irinotecan generally shows higher activity in colorectal cancer, while topotecan is more often used for ovarian and small‑cell lung cancers. Compared with oxaliplatin‑based regimens, Irinotecan offers a different toxicity profile, with more gastrointestinal effects but less peripheral neuropathy.

Irinotecan Accord should be stored refrigerated at 2‑8 °C, protected from light, and never frozen. The solution must be kept in its original container, and any unused portion should be discarded according to local regulations after the recommended storage period.

Irinotecan Accord is given as an intravenous infusion by a qualified healthcare professional. The infusion is typically administered over 30 to 90 minutes, depending on the prescribed protocol, and may be repeated every two to three weeks as part of a treatment cycle.

The most critical adverse events include severe neutropenia or febrile neutropenia, life‑threatening diarrhea or colitis, significant liver enzyme elevations, and rare hypersensitivity reactions. Patients should be monitored closely for signs of infection, dehydration, or hepatic dysfunction throughout therapy.

Irinotecan Accord is contraindicated in patients with known hypersensitivity to irinotecan or its excipients, those with severe bone‑marrow suppression, and pregnant women unless the benefit outweighs the risk. Caution is also advised for individuals with significant hepatic or renal impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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