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 intravenous solution for intravenous use. It treats metastatic colorectal cancer and other solid tumors in adult patients and is administered under medical supervision in oncology settings.

GNH India supplies Irinotecan Accord as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide. The company adheres to stringent quality standards and provides reliable logistics for hospitals, pharmacies and clinical trial sites across multiple regions globally efficiently.

Manufacturer / TM Owner

Accord Healthcare S.L.U.

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Indications & Clinical Uses

Irinotecan is employed in oncology to target cancers that depend on topoisomerase I activity.

  • Metastatic colorectal cancer: used in combination regimens to improve overall survival in adult patients.
  • Advanced gastric cancer: incorporated into selected multi‑drug protocols under specialist supervision.
  • Pancreatic cancer: considered as part of combination chemotherapy for eligible patients.

How It Works

  • After intravenous infusion, irinotecan is converted by hepatic carboxylesterases to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, preventing the re‑ligation step of DNA replication. This inhibition leads to accumulation of DNA breaks, triggering apoptosis in rapidly dividing tumor cells. The drug distributes widely, and SN‑38 is further metabolized by glucuronidation, a process influenced by genetic variants of UGT1A1, which can affect exposure and toxicity.

Side Effects

Irinotecan is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: may occur during or after infusion.
  • Fatigue: generalized tiredness reported by many patients.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe colitis: life‑threatening inflammation of the colon.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.

Precautions & Warnings

When using Irinotecan, clinicians should observe specific safety measures to minimize risks.

  • Monitor blood counts: perform regular complete blood count tests to detect neutropenia early.
  • Assess liver function: evaluate hepatic enzymes before each cycle as metabolism depends on liver activity.
  • Adjust for renal impairment: consider dose modification in patients with reduced kidney function.
  • Avoid in known hypersensitivity: discontinue if allergic reactions such as rash or bronchospasm occur.
  • Pregnancy and breastfeeding: use only if potential benefit justifies potential risk, as safety data are limited.
  • Store at ambient temperature: keep the solution in the original container, protect from light and moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): can lower SN‑38 concentrations and reduce efficacy.
  • UGT1A1 inhibitors (e.g., atazanavir): raise SN‑38 levels, increasing risk of severe toxicity.
  • Concurrent myelosuppressive chemotherapy: may intensify neutropenia and thrombocytopenia.

Moderate Interactions (Monitor Closely)

  • Warfarin: may alter INR, necessitating closer coagulation monitoring.
  • Fluoropyrimidines (e.g., 5‑FU): combined use can heighten hematologic adverse effects.

Frequently Asked Questions

Irinotecan Accord is an intravenous chemotherapy used primarily to treat metastatic colorectal cancer and, under specialist guidance, other solid tumors such as advanced gastric or pancreatic cancer. It is part of combination regimens designed to improve survival outcomes in adult oncology patients.

Irinotecan is a pro‑drug that is enzymatically converted to SN‑38, a potent inhibitor of topoisomerase I. By blocking the re‑ligation step of DNA replication, SN‑38 causes accumulation of DNA breaks, leading to apoptosis of rapidly dividing cancer cells. Metabolism and clearance are influenced by liver enzymes, especially UGT1A1.

The dose of Irinotecan Accord is individualized by the prescribing oncologist based on factors such as the patient’s body surface area, disease stage, prior therapies, liver function, and genetic markers like UGT1A1 genotype. No fixed dosing schedule is provided here; the prescriber sets the regimen.

Safety data for Irinotecan during pregnancy and lactation are limited. It is classified as pregnancy category unknown, and the drug can cross the placenta and be excreted in breast milk. Use is only considered when the potential benefit outweighs the potential risk to the fetus or infant.

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 worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, with topotecan being a closely related alternative. Compared with topotecan, irinotecan is typically used for colorectal cancer and has a distinct metabolic pathway producing SN‑38. Oxaliplatin, a platinum‑based agent, is another common partner in colorectal regimens but works via DNA cross‑linking rather than topoisomerase inhibition.

Irinotecan Accord should be stored at ambient temperature, below 25 °C, in its original packaging. Protect the solution from direct light, moisture, and extreme temperature fluctuations. Once reconstituted, follow the manufacturer’s stability guidelines for use within the recommended time frame.

Irinotecan Accord is given as an 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 pre‑medication and monitoring for infusion‑related reactions as per institutional guidelines.

The most serious risks include severe neutropenia or febrile neutropenia, which can lead to life‑threatening infections; severe or delayed diarrhea that may progress to colitis; hypersensitivity reactions ranging from rash to anaphylaxis; and hepatic toxicity. Patients should be monitored closely for these events throughout treatment.

Irinotecan Accord should be avoided in patients with known hypersensitivity to irinotecan or any component of the formulation, those with severe hepatic impairment, and individuals with uncontrolled infections. Caution is also advised for patients with significant bone‑marrow suppression or those taking interacting medications that could increase toxicity.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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