Product image of Irinotecan Accordpharma (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotecan Accordpharma

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Accordpharma (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Accordpharma, is a topoisomerase I inhibitor presented as an intravenous solution for infusion use. It is indicated for the treatment of colorectal cancer and metastatic colorectal cancer in adult patients.
GNH India supplies Irinotecan Accordpharma as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Accord Healthcare Polska Sp. Z O.O.

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Indications & Clinical Uses

Irinotecan Accordpharma acts on malignant cells of the colorectal cancer pathway.

  • Colorectal cancer: provides cytotoxic therapy to shrink or control primary tumors.
  • Metastatic colorectal cancer: used to reduce tumor burden and improve survival in advanced disease.
  • Adjuvant therapy for colorectal cancer: administered after surgery to lower the risk of recurrence.

How It Works

  • Irinotecan Hydrochloride Trihydrate is a topoisomerase I inhibitor. It binds to the DNA‑topoisomerase I complex, preventing relegation of single‑strand DNA breaks that occur during replication. The accumulation of unrepaired DNA breaks leads to replication arrest and apoptosis of rapidly dividing cancer cells.

Side Effects

Irinotecan may cause a range of adverse reactions during treatment.

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: may need anti‑emetic support.
  • Fatigue: generalized tiredness affecting daily activities.
  • Alopecia: temporary hair loss.
  • Abdominal pain: discomfort in the stomach area.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils, a medical emergency.
  • Severe colitis or intestinal perforation from uncontrolled diarrhea.
  • Hepatic toxicity: elevated liver enzymes or jaundice.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Tumor lysis syndrome: rapid tumor cell breakdown causing metabolic disturbances.
  • Severe mucositis: painful inflammation of the mouth and gastrointestinal lining.

Precautions & Warnings

Prior to initiating Irinotecan therapy, clinicians should evaluate patient‑specific risk factors and monitor for toxicity.

  • Renal function: assess creatinine clearance and adjust if necessary.
  • Hepatic function: monitor liver enzymes; dose may need modification in impairment.
  • Myelosuppression: perform regular complete blood counts to detect neutropenia.
  • Diarrhea: implement prophylactic loperamide and educate patients on early reporting.
  • Pregnancy: avoid use unless the potential benefit justifies the risk to the fetus.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): may markedly reduce irinotecan exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): can increase active metabolite levels and toxicity.

Moderate Interactions (Monitor Closely)

  • Antiemetics such as ondansetron: may affect metabolism and require dose adjustment.
  • Warfarin: potential for increased bleeding risk; monitor INR.
  • Other myelosuppressive agents: additive bone‑marrow suppression warrants close blood count monitoring.

Frequently Asked Questions

Irinotecan Accordpharma is a chemotherapy agent indicated for the treatment of colorectal cancer and metastatic colorectal cancer. It is administered intravenously under the supervision of an oncologist as part of a systemic cancer‑treatment regimen.

Irinotecan Hydrochloride inhibits the enzyme topoisomerase I, which normally relaxes DNA during replication. By stabilising the DNA‑topoisomerase I complex, it prevents the re‑ligation of single‑strand DNA breaks, leading to accumulation of DNA damage and ultimately cell death in rapidly dividing tumor cells.

The dose of Irinotecan Accordpharma is individualized by the prescribing oncologist. It is calculated based on factors such as body surface area, disease stage, and the patient’s renal and hepatic function. No fixed regimen is provided here; the prescriber determines the appropriate schedule.

Safety of Irinotecan in pregnancy and lactation has not been established. It is generally contraindicated during pregnancy and breastfeeding unless the potential therapeutic benefit outweighs the risk to the fetus or infant. Patients should discuss reproductive considerations with their healthcare provider.

To order, submit an enquiry on the Irinotecan Accordpharma 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 (including cold‑chain if required) and any necessary import documentation.

Compared with other topoisomerase I inhibitors, Irinotecan has a distinct toxicity profile, notably severe diarrhea and neutropenia. Relative to oxaliplatin‑based regimens, it offers a different mechanism of action and may be used alone or in combination depending on clinical guidelines and patient tolerance.

Irinotecan Accordpharma should be stored at 2‑8 °C, protected from light, and must not be frozen or shaken. Before administration, allow the solution to reach room temperature if required and inspect for any particulate matter or discoloration.

Irinotecan is given as an intravenous infusion, typically over 30 to 90 minutes, by a qualified healthcare professional in a clinical setting. The infusion rate may be adjusted based on patient tolerance, protocol specifications, and any observed adverse reactions.

The most serious adverse events include severe neutropenia, febrile neutropenia, life‑threatening diarrhea (including colitis), and rare hypersensitivity reactions. Early detection through regular blood counts and prompt management of gastrointestinal symptoms are essential to mitigate these risks.

Patients with known hypersensitivity to irinotecan or its excipients, uncontrolled infections, severe bone‑marrow suppression, or significant hepatic impairment should avoid this medication. Clinicians must evaluate each individual’s medical history before prescribing.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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