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 a sterile intravenous solution for infusion use. It is employed in the treatment of metastatic colorectal cancer in adult patients.

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 Romania Srl

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Indications & Clinical Uses

Irinotecan Kabi is a topoisomerase I inhibitor used in the management of colorectal cancer.

  • Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This stabilisation prevents relegation of single‑strand DNA breaks, leading to accumulation of DNA damage, inhibition of DNA 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

  • Nausea: mild to moderate upset stomach.
  • Vomiting: occasional episodes during or after infusion.
  • Diarrhea: can be severe and require supportive care.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Fatigue: generalized tiredness.
  • Alopecia: temporary hair loss.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count, a medical emergency.
  • Severe colitis: intense inflammation of the colon.
  • Hepatotoxicity: elevated liver enzymes or liver injury.
  • Anaphylactic reactions: rare but potentially life‑threatening hypersensitivity.
  • Tumor lysis syndrome: rapid tumor breakdown causing metabolic disturbances.

Precautions & Warnings

Before initiating therapy, clinicians should assess baseline health status and monitor patients closely.

  • Blood count monitoring: perform complete blood counts before each cycle.
  • Liver function assessment: evaluate hepatic enzymes and bilirubin levels.
  • Bowel obstruction risk: screen for prior gastrointestinal surgery or obstruction.
  • Antiemetic prophylaxis: administer anti‑nausea medication prior to infusion.
  • Dose adjustment: consider renal or hepatic impairment when dosing.
  • Store at controlled room temperature: keep in original container, protect from light and moisture.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase SN‑38 exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia.
  • Concurrent high‑dose irinotecan formulations: may cause cumulative toxicity.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin): reduce drug exposure.
  • Anticoagulants (e.g., warfarin): may enhance bleeding risk.
  • Other myelosuppressive agents (e.g., carboplatin): increase bone‑marrow suppression.

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer. It is used in combination with fluoropyrimidine‑based regimens to improve survival outcomes in adult patients.

Irinotecan is a pro‑drug that is converted to SN‑38 inside cancer cells. SN‑38 binds to the DNA‑topoisomerase I complex, preventing the re‑ligation of single‑strand DNA breaks, which leads to accumulation of DNA damage and ultimately cell death.

The specific dose of Irinotecan Kabi is determined by the prescribing oncologist based on factors such as patient weight, disease stage, and treatment protocol. Only a qualified healthcare professional should set the dosing schedule.

Irinotecan is classified as contraindicated in pregnancy because it may cause fetal harm. It is also not recommended while breastfeeding, as it can be excreted in milk and affect the infant. Consultation with a specialist is essential.

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.

Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines or oxaliplatin. When combined with fluoropyrimidines, it provides a survival benefit comparable to other combination regimens, but its toxicity profile—particularly diarrhea and neutropenia—differs and requires specific management.

Irinotecan Kabi should be stored at controlled room temperature, below 25 °C, in its original packaging. Protect the product from light, moisture, and extreme temperature fluctuations. Follow aseptic techniques when preparing the infusion solution.

Irinotecan Kabi is given by intravenous infusion, typically over 30 to 90 minutes depending on the prescribed regimen. The infusion is performed in a clinical setting by qualified healthcare personnel, with monitoring for infusion‑related reactions.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and rare anaphylactic reactions. Prompt recognition and supportive care are essential to mitigate these complications.

Patients with known hypersensitivity to Irinotecan or its excipients, those with uncontrolled infections, severe hepatic impairment, or a history of bowel obstruction should not receive Irinotecan. Additionally, pregnant women and nursing mothers are contraindicated.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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