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 an injectable solution for intravenous use. It is employed in the treatment of several solid tumours, including metastatic colorectal cancer, small cell lung cancer, ovarian cancer and gastric cancer, in adult oncology patients, and is indicated for use in combination chemotherapy regimens.

GNH India supplies Irinotecan Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, transplant facilities and pharmacies worldwide, ensuring quality‑assured product availability across global markets.

Manufacturer / TM Owner

Accord Healthcare Polska Sp. Z O.O.

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Indications & Clinical Uses

Irinotecan is used in oncology to treat solid tumours that are responsive to topoisomerase I inhibition.

  • Metastatic colorectal cancer: improves survival when combined with other chemotherapeutic agents.
  • Small cell lung cancer: used as part of multi‑drug regimens for disease control.
  • Ovarian cancer: contributes to tumour reduction in advanced stages.
  • Gastric cancer: incorporated into combination therapy to enhance response rates.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the enzyme‑DNA complex, it prevents relegation of single‑strand DNA breaks, leading to accumulation of DNA damage, inhibition of replication and transcription, and ultimately cancer cell death.

Side Effects

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

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Diarrhea: often severe and may require supportive care.
  • Nausea and vomiting: typical chemotherapy‑related symptoms.
  • Alopecia: hair loss during treatment cycles.
  • Fatigue: generalized tiredness affecting daily activities.
  • Abdominal cramping: discomfort in the gastrointestinal tract.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils requiring urgent medical attention.
  • Severe colitis or intestinal perforation: life‑threatening gastrointestinal complications.
  • Anaphylactic reactions: rare hypersensitivity requiring immediate intervention.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Severe electrolyte disturbances: especially hypokalemia and hyponatremia.
  • Cardiac arrhythmias: uncommon but possible in vulnerable patients.

Precautions & Warnings

Before initiating Irinotecan therapy, clinicians should evaluate several safety parameters.

  • Monitor blood counts: perform regular CBCs to detect neutropenia early.
  • Assess liver function: obtain baseline and periodic LFTs as hepatic impairment alters drug metabolism.
  • Maintain hydration: ensure adequate fluid intake to mitigate severe diarrhea.
  • Avoid strong CYP3A4 inhibitors: concurrent use may increase Irinotecan exposure and toxicity.
  • Pregnancy and lactation: prescribe only when potential benefits justify potential risks to the fetus or infant.
  • Store at ambient temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Irinotecan can interact with other medicines, influencing its safety and effectiveness.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may raise Irinotecan plasma levels and toxicity.
  • Concurrent myelosuppressive agents: increase risk of severe bone‑marrow suppression.
  • Live vaccines: heightened infection risk due to immunosuppression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin): may reduce therapeutic efficacy.
  • Anticholinergic drugs: can exacerbate constipation associated with Irinotecan.
  • Warfarin: may alter INR and affect anticoagulation control.

Frequently Asked Questions

Irinotecan Accord is an intravenous chemotherapy agent indicated for the treatment of several solid tumours, including metastatic colorectal cancer, small cell lung cancer, ovarian cancer and gastric cancer. It is typically used as part of combination regimens to improve response rates and overall survival in adult oncology patients.

Irinotecan is a pro‑drug that is metabolised inside cancer cells to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the topoisomerase‑DNA complex, SN‑38 prevents the re‑ligation of single‑strand DNA breaks, leading to accumulation of DNA damage, inhibition of replication and transcription, and ultimately tumour cell death.

The dose of Irinotecan Accord is individualized and determined by the prescribing oncologist based on factors such as cancer type, treatment protocol, patient weight, renal and hepatic function, and prior therapy. No fixed dosing schedule is provided here; clinicians follow established guidelines and adjust as needed.

Safety data for Irinotecan in pregnancy and lactation are limited. It should be used only if the potential therapeutic benefit justifies the potential risk to the fetus or infant. Breastfeeding is generally not recommended during treatment because the drug can be excreted in milk.

To order 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 if required) and necessary import documentation.

The primary alternative to Irinotecan is topotecan, another topoisomerase I inhibitor. While both share a similar mechanism, Irinotecan is often preferred for colorectal and gastric cancers because of its established efficacy in those indications, whereas topotecan is more commonly used in ovarian and small‑cell lung cancers. Toxicity profiles also differ, with Irinotecan causing more severe diarrhea and topotecan being associated with greater myelosuppression.

Irinotecan Accord should be stored at ambient temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture and direct light, and avoid freezing. Follow standard aseptic handling procedures when preparing the intravenous solution.

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

The most serious adverse events include severe neutropenia (especially febrile neutropenia), life‑threatening diarrhea or colitis that may lead to intestinal perforation, and rare hypersensitivity reactions. Prompt medical evaluation is essential if patients develop fever, persistent diarrhea, abdominal pain, or signs of infection.

Irinotecan Accord is contraindicated in patients with known hypersensitivity to Irinotecan or any of its excipients, those with severe bone‑marrow suppression (e.g., neutrophil count < 500 µL), and individuals with uncontrolled infections. Caution is also advised for patients with significant hepatic impairment or pre‑existing gastrointestinal disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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