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, the active ingredient in Irinotecan Kabi, is a topoisomerase I inhibitor presented as an injectable solution for intravenous use. It is employed in the treatment of colorectal cancers, particularly metastatic disease, and is administered under the supervision of oncology specialists.

GNH India supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, adhering to EU manufacturing standards and providing reliable global distribution. All batches meet stringent regulatory requirements and are shipped with appropriate temperature control.

Manufacturer / TM Owner

Fresenius Kabi Nv/Sa

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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.
  • Colorectal cancer (adjuvant setting): reduces recurrence risk after surgical resection.
  • Refractory colorectal cancer: provides a therapeutic option after failure of first‑line therapies.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex and stabilizes it. This prevents relegation of single‑strand DNA breaks, leading to accumulation of DNA damage, inhibition of replication, and ultimately cancer cell death.

Side Effects

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

Common Side Effects

  • Diarrhea: often delayed and may be severe.
  • Nausea and vomiting.
  • Neutropenia.
  • Fatigue.

Serious or Rare Side Effects

  • Febrile neutropenia.
  • Life‑threatening diarrhea or intestinal perforation.
  • Severe allergic reactions (anaphylaxis).

Precautions & Warnings

Before initiating therapy, clinicians should observe several safety measures.

  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess liver function: check enzymes before and during therapy.
  • Ensure adequate hydration: reduce risk of severe diarrhea.
  • Adjust dose in hepatic impairment: reduce dosage per clinical guidelines.
  • Avoid concurrent strong CYP3A4 inhibitors: may increase toxicity.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Irinotecan interacts with several drug classes; awareness helps avoid harmful outcomes.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): increase exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): raise risk of neutropenia and diarrhea.
  • Concurrent myelosuppressive chemotherapy: additive bone‑marrow toxicity.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce efficacy.
  • Anticoagulants (e.g., warfarin): monitor INR for bleeding risk.
  • Antidiarrheal agents (e.g., loperamide) when used prophylactically: may mask symptoms.

Frequently Asked Questions

Irinotecan Kabi is indicated for the treatment of metastatic colorectal cancer and other colorectal cancer settings. It is used as part of combination chemotherapy regimens to improve survival and disease control in patients with advanced disease.

Irinotecan is converted inside cells to the active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the enzyme from resealing single‑strand DNA breaks, leading to accumulation of DNA damage, inhibition of replication, and ultimately death of rapidly dividing cancer cells.

The prescribed dose of Irinotecan Kabi is determined by the treating oncologist based on factors such as the patient’s body surface area, disease stage, liver function, and prior treatment history. The prescriber tailors the regimen to achieve optimal efficacy while managing safety.

Irinotecan is classified as contraindicated in pregnancy because it may cause fetal harm. Women of child‑bearing potential should use effective contraception. Limited data exist for breastfeeding, and the drug is generally not recommended while nursing due to potential infant exposure.

To order Irinotecan Kabi, 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 required), and necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines, oxaliplatin, or targeted agents. It is often combined with fluoropyrimidines for synergistic effect and is especially valuable after progression on first‑line regimens, whereas agents like oxaliplatin act on DNA cross‑linking.

Irinotecan Kabi should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. During transport, cold‑chain conditions are required to maintain product stability. Once prepared for infusion, it should be used promptly according to the manufacturer’s instructions.

Irinotecan Kabi is given by intravenous infusion, typically over 30 to 90 minutes depending on the protocol. The infusion is performed in a clinical setting by qualified healthcare professionals, with monitoring for infusion‑related reactions and supportive care measures as needed.

The most serious risks include severe neutropenia (especially febrile neutropenia), life‑threatening delayed diarrhea that can lead to colitis or intestinal perforation, and rare but severe allergic reactions such as anaphylaxis. Prompt recognition and management of these events are essential.

Patients with known hypersensitivity to irinotecan or any of its excipients should avoid the drug. It is also contraindicated in individuals with severe hepatic impairment, uncontrolled infections, or those receiving concurrent strong CYP3A4 or UGT1A1 inhibitors that cannot be safely managed.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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