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

Irinotecan Kabi

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Kabi (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Kabi, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer and as adjuvant therapy for colon cancer after surgical resection.

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

Manufacturer / TM Owner

Fresenius Kabi Polska Sp. Z O.O.

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Indications & Clinical Uses

  • Irinotecan Kabi is a topoisomerase I inhibitor used in colorectal cancer treatment pathways.
  • Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based regimens.
  • Adjuvant therapy for colon cancer: reduces risk of disease recurrence after curative surgery.
  • Colorectal cancer (in combination therapy): enhances tumor response when used with other cytotoxic agents.

How It Works

  • After intravenous administration, Irinotecan is converted by hepatic carboxylesterases to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, stabilizing it and preventing relegation of single‑strand DNA breaks. This inhibition blocks DNA replication and transcription, leading to apoptosis of rapidly dividing cancer cells.

Side Effects

Irinotecan Kabi may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: may be managed with antiemetics.
  • Alopecia: temporary hair loss.
  • Fatigue: generalized tiredness.
  • Abdominal cramping: discomfort in the stomach area.

Serious or Rare Side Effects

  • Severe neutropenic infection: febrile neutropenia requiring hospitalization.
  • Life‑threatening diarrhea: may lead to dehydration and electrolyte imbalance.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Cardiac toxicity: rare arrhythmias or ischemic events.
  • Secondary malignancies: potential long‑term risk of new cancers.

Precautions & Warnings

  • Before initiating Irinotecan Kabi, clinicians should assess patient-specific risk factors and monitor laboratory parameters.
  • Baseline blood counts: verify adequate neutrophil and platelet levels.
  • Liver function: evaluate hepatic enzymes due to metabolism dependence.
  • Renal function: adjust monitoring if creatinine clearance is impaired.
  • Pregnancy: avoid use; drug is classified Category D and may cause fetal harm.
  • Concomitant medications: review for agents that may exacerbate neutropenia or diarrhea.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the solution.

Avoid Interactions

Irinotecan Kabi can interact with several drugs that affect its metabolism or toxicity profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase SN‑38 exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia.
  • High‑dose irinotecan with other myelosuppressive agents: may cause life‑threatening bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticholinergic agents: may worsen constipation and abdominal cramping.
  • Anticoagulants (e.g., warfarin): monitor INR for bleeding risk.
  • Proton pump inhibitors: potential alteration of gastrointestinal absorption.
  • Diuretics: monitor electrolytes during severe diarrhea.
  • Herbal supplements affecting liver enzymes: assess for possible interaction.

Frequently Asked Questions

Irinotecan Kabi is indicated for the treatment of metastatic colorectal cancer and as adjuvant therapy for colon cancer after surgical resection. It is used as part of combination chemotherapy regimens to improve survival and reduce disease recurrence.

After intravenous infusion, Irinotecan is converted to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks, halting DNA replication and transcription in rapidly dividing cancer cells, ultimately leading to cell death.

The specific dose of Irinotecan Kabi is determined by the prescribing oncologist based on the patient’s weight, disease stage, and treatment protocol. Dosing regimens vary and should be individualized according to clinical guidelines and patient tolerance.

Irinotecan is classified as Pregnancy Category D, indicating evidence of fetal risk. It should not be used during pregnancy unless the potential benefit justifies the risk. Breastfeeding is not recommended while receiving Irinotecan because the drug can be excreted in milk and may harm the infant.

To place an order, 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 needed), and necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines and oxaliplatin. Compared with agents like 5‑fluorouracil, Irinotecan provides an alternative pathway to disrupt DNA replication, and it is often combined with these drugs to enhance overall treatment efficacy.

Irinotecan Kabi should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. The solution should be kept in its original packaging until ready for preparation and administration to maintain stability.

Irinotecan Kabi is given as an intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and duration are determined by the prescribing protocol, and patients are monitored for infusion‑related reactions and toxicity throughout the administration.

The most serious risks include severe neutropenia leading to infection, life‑threatening diarrhea that can cause dehydration and electrolyte imbalance, and rare but serious hepatic toxicity. Prompt recognition and supportive care are essential to manage these potentially fatal complications.

Patients with known hypersensitivity to Irinotecan or its excipients, those with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment should not receive Irinotecan. Additionally, it is contraindicated in pregnant women and should be avoided in breastfeeding mothers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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