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 injection solution for intravenous use. It is indicated for the treatment of metastatic colorectal cancer in adult patients and is approved in the European Union market.

GNH India supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to EU quality standards and provides cold‑chain logistics where required. Clients benefit from reliable delivery timelines and regulatory support for importation.

Manufacturer / TM Owner

Fresenius Kabi Hungary Kft.

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Indications & Clinical Uses

Irinotecan Kabi is used in colorectal cancer treatment regimens that target tumor cell proliferation.

  • Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy.
  • Refractory colorectal cancer: provides clinical benefit in patients whose disease has progressed after first‑line therapy.
  • Advanced colorectal cancer (first‑line): forms part of the standard FOLFIRI regimen to reduce tumor burden.

How It Works

  • Irinotecan Hydrochloride Trihydrate is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilizing the DNA‑topoisomerase I complex, it prevents religation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately tumor cell apoptosis.

Side Effects

Irinotecan Kabi may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting
  • Diarrhea, which can be severe
  • Neutropenia and leukopenia
  • Alopecia (hair loss)
  • Fatigue and weakness
  • Decreased appetite

Serious or Rare Side Effects

  • Febrile neutropenia or severe bone‑marrow suppression
  • Life‑threatening colitis or severe diarrhea
  • Hepatic toxicity with elevated transaminases
  • Hypersensitivity reactions including anaphylaxis
  • Pulmonary toxicity such as interstitial pneumonitis
  • Severe electrolyte disturbances

Precautions & Warnings

Before initiating therapy, clinicians should assess patient‑specific factors and monitor for toxicity.

  • Dose adjustment: required in patients with hepatic impairment.
  • Baseline labs: obtain complete blood count and liver function tests prior to each cycle.
  • Diarrhea management: initiate antidiarrheal prophylaxis and monitor fluid balance.
  • Myelosuppression: monitor neutrophil counts and consider growth‑factor support if needed.
  • Pregnancy and lactation: avoid use unless benefits clearly outweigh potential risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with other medicines that affect its metabolism or increase toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin) markedly reduce irinotecan exposure.
  • UGT1A1 inhibitors (e.g., atazanavir) can increase SN‑38 levels and raise risk of severe neutropenia.
  • Concurrent myelosuppressive agents may cause profound bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs may exacerbate irinotecan‑induced diarrhea.
  • Anticoagulants can increase bleeding risk when hepatic function is compromised.
  • Moderate CYP3A4 inhibitors (e.g., ketoconazole) may raise plasma concentrations, requiring dose adjustment.

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent used primarily to treat metastatic colorectal cancer. It is administered as part of combination regimens such as FOLFIRI, where it helps to slow tumor growth and improve survival outcomes in adult patients.

After infusion, Irinotecan is metabolised to the active metabolite SN‑38, which inhibits the enzyme topoisomerase I. This inhibition prevents the re‑joining of single‑strand DNA breaks during replication, causing DNA damage that triggers cancer cell death.

The dosing regimen for Irinotecan Kabi is individualized by the prescribing oncologist based on factors such as body surface area, disease stage, and patient tolerance. Specific dose calculations and schedule are determined by the treating physician and are not disclosed publicly.

The safety of Irinotecan Kabi in pregnancy and lactation has not been established. It is generally contraindicated unless the potential therapeutic benefit justifies the potential risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment.

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 where needed) and necessary import documentation.

Irinotecan is the most widely used topoisomerase I inhibitor for colorectal cancer, offering a well‑characterised efficacy and safety profile. Compared with newer agents, it has extensive clinical data, but may have higher rates of diarrhea and neutropenia, requiring proactive supportive care.

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

Irinotecan Kabi is supplied as an injectable solution for intravenous infusion. It is typically administered over a 30‑ to 90‑minute period, depending on the prescribed regimen, and must be prepared by qualified healthcare personnel in a clinical setting.

The most serious adverse events include severe neutropenia, febrile neutropenia, life‑threatening diarrhea or colitis, hepatic toxicity, and rare hypersensitivity reactions. Prompt monitoring and early intervention are essential to mitigate these risks.

Patients with known hypersensitivity to Irinotecan or any of its excipients, those with severe hepatic impairment, or individuals with uncontrolled infections should avoid the drug. Additionally, it is contraindicated in pregnant women unless absolutely necessary.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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