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 injectable solution for intravenous administration. It is used in the treatment of metastatic and advanced colorectal cancer, primarily in adult patients who have disease progression after standard therapies.

GNH India supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide, providing reliable access to this chemotherapy agent for qualified healthcare providers and ensuring compliance with local regulations.

Manufacturer / TM Owner

Fresenius Kabi Deutschland Gmbh

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Indications & Clinical Uses

  • Irinotecan is a topoisomerase I inhibitor used in the management of colorectal cancer.
  • Metastatic colorectal cancer: improves survival in patients with disease spread beyond the colon.
  • Advanced colorectal cancer: provides disease control in patients with locally advanced disease.
  • Colorectal cancer (first‑line therapy): used in combination with other agents for initial treatment of eligible patients.

How It Works

  • After intravenous infusion, irinotecan is converted intracellularly to its active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex and prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately cancer cell death.

Side Effects

Irinotecan may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Diarrhea: may be severe and require supportive care.
  • Nausea and vomiting: often managed with anti‑emetics.
  • Fatigue: general tiredness experienced during treatment.
  • Alopecia: hair loss that may be temporary.
  • Anemia: decreased red blood cell count causing fatigue.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils requiring urgent medical attention.
  • Severe colitis or intestinal perforation: life‑threatening gastrointestinal complications.
  • Hepatotoxicity: liver enzyme elevations that may progress to liver injury.
  • Severe allergic reactions: anaphylaxis or hypersensitivity requiring immediate treatment.
  • Tumor lysis syndrome: rapid tumor cell breakdown causing metabolic disturbances.
  • Cardiotoxicity: rare heart rhythm abnormalities.

Precautions & Warnings

  • Before initiating therapy, clinicians should assess patient-specific factors and monitor for potential complications.
  • Monitor blood counts: perform regular complete blood count tests to detect neutropenia.
  • Assess liver function: evaluate hepatic enzymes as irinotecan metabolism is liver‑dependent.
  • Evaluate bowel status: screen for pre‑existing diarrhea or intestinal obstruction.
  • Adjust dose in hepatic impairment: reduce dosage for patients with significant liver dysfunction.
  • Avoid use in known hypersensitivity: discontinue if severe allergic reaction occurs.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the vial.

Avoid Interactions

Irinotecan can interact with other medicines, influencing its efficacy or toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampicin): may reduce SN‑38 formation and therapeutic effect.
  • UGT1A1 inhibitors (e.g., atazanavir): can increase SN‑38 exposure and risk of severe neutropenia.
  • Concurrent myelosuppressive agents: may cause additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): monitor coagulation parameters due to potential bleeding risk.
  • Drugs affecting gastrointestinal motility (e.g., loperamide): may alter diarrhea severity.
  • Other chemotherapy agents (e.g., oxaliplatin): adjust dosing and monitor for overlapping toxicities.

Frequently Asked Questions

Irinotecan Kabi is an injectable chemotherapy medication indicated for the treatment of metastatic and advanced colorectal cancer in adult patients, typically when disease has progressed after standard therapies.

After infusion, Irinotecan is converted to the active metabolite SN‑38, which binds to topoisomerase I on DNA, preventing the re‑ligation of single‑strand breaks. This leads to accumulation of DNA damage and triggers cancer cell death.

The dose of Irinotecan is individualized and determined by the prescribing oncologist based on factors such as patient weight, disease stage, prior therapies, and organ function. No standard dose is provided here.

Irinotecan is classified as contraindicated during pregnancy and breastfeeding because it may cause fetal harm and is excreted in breast milk. Women of child‑bearing potential should use effective contraception and discuss risks with their physician.

To place an order, submit an enquiry on the Irinotecan Kabi 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 import documentation.

The primary alternative within the topoisomerase I inhibitor class is topotecan, which is also used for certain solid tumours. Irinotecan generally has a broader indication in colorectal cancer and is administered intravenously, whereas topotecan is often given orally or intravenously for different tumour types. Toxicity profiles differ, with Irinotecan more associated with severe diarrhea.

Irinotecan Kabi should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Before use, the vial should be inspected for particulate matter and administered using aseptic technique as directed by a qualified healthcare professional.

Irinotecan is given as an intravenous infusion, typically over 30 to 90 minutes depending on the regimen. The infusion is performed by trained medical staff in a clinical setting, with appropriate monitoring for infusion‑related reactions and vital signs.

The most serious risks include febrile neutropenia, severe or life‑threatening diarrhea (potentially leading to colitis or perforation), hepatic toxicity, and rare allergic reactions. Prompt medical evaluation is required if fever, persistent diarrhea, jaundice, or signs of an allergic response occur.

Patients with known hypersensitivity to Irinotecan or its excipients, those with severe hepatic impairment, active uncontrolled infections, or pre‑existing severe neutropenia should not receive Irinotecan. Use is also contraindicated during pregnancy and lactation.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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