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 use. It is indicated for the treatment of metastatic colorectal cancer in adult patients, typically as part of combination chemotherapy regimens.

GNH India supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide, with distribution aligned to EU regulatory standards and cold‑chain logistics where required. The company ensures product integrity through validated packaging and rigorous quality control.

Manufacturer / TM Owner

Fresenius Kabi France S.A.S.

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Indications & Clinical Uses

  • Irinotecan Kabi is a topoisomerase I inhibitor used in colorectal cancer therapy.
  • Metastatic colorectal cancer: improves survival when combined with fluoropyrimidine‑based regimens.
  • Small cell lung cancer: provides benefit as second‑line therapy in combination with other 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, which ultimately blocks DNA replication and transcription, leading to tumor cell death.

Side Effects

Irinotecan Kabi may cause a range of adverse reactions.

Common Side Effects

  • Neutropenia: decreased white blood cell count increasing infection risk.
  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Nausea and vomiting: typical chemotherapy‑related symptoms.
  • Alopecia: hair loss during treatment.
  • Fatigue: generalized tiredness.
  • Anemia: reduced red blood cell levels.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils, requiring urgent care.
  • Severe colitis: life‑threatening inflammation of the colon.
  • Hepatic toxicity: elevated liver enzymes or jaundice.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Pulmonary toxicity: interstitial pneumonitis or fibrosis.
  • Hemorrhagic events: bleeding due to thrombocytopenia.

Precautions & Warnings

  • Use of Irinotecan Kabi requires careful monitoring and patient assessment.
  • Dose adjustment in renal impairment: reduce dose based on renal function.
  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess liver function: adjust for hepatic impairment.
  • Avoid in patients with known hypersensitivity to irinotecan or its components.
  • Pregnancy and lactation: use only if benefits outweigh risks; limited data.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan Kabi can interact with several drug classes, necessitating vigilance.

Major Interactions (Avoid)

  • Concurrent use with strong CYP3A4 inhibitors (e.g., ketoconazole) may increase toxicity.
  • Co‑administration with UGT1A1 inhibitors (e.g., atazanavir) can raise SN‑38 levels.
  • Combination with other myelosuppressive agents may cause severe bone marrow suppression.

Moderate Interactions (Monitor Closely)

  • Concurrent use with anticoagulants may increase bleeding risk.
  • Use with other antidiarrheal agents may mask symptoms.
  • Combination with drugs affecting electrolyte balance may require monitoring.

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and for small cell lung cancer as part of combination regimens. It works by interfering with DNA replication in cancer cells.

After infusion, irinotecan is metabolized to SN‑38, which binds to the DNA‑topoisomerase I complex and prevents the re‑ligation of single‑strand DNA breaks. This inhibition blocks DNA replication and transcription, leading to tumor cell death.

The dose of Irinotecan Kabi is individualized by the prescribing oncologist based on factors such as cancer type, treatment protocol, patient weight, and organ function. Specific dosing regimens are not provided here.

Safety data for Irinotecan in pregnancy and lactation are limited. It should only be used if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by the treating 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.

Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as oxaliplatin (a platinum compound) or 5‑fluorouracil (a pyrimidine analog). Its unique mechanism targets DNA‑topoisomerase I, offering an alternative pathway for tumor control, often used in combination to enhance efficacy.

Irinotecan Kabi should be stored refrigerated at 2‑8 °C. Keep the vials in their original packaging, protect from light, and do not freeze or shake the solution before administration.

The product is supplied as an injectable solution for intravenous infusion. Administration is performed by qualified healthcare professionals in a clinical setting, following the prescribing information for infusion rate and pre‑medication protocols.

Serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and hypersensitivity reactions such as anaphylaxis. Patients should be monitored closely for these events throughout treatment.

Irinotecan Kabi is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients. Caution is also advised for individuals with severe hepatic impairment, uncontrolled infections, or those who are pregnant without a clear benefit‑risk assessment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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