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 solution for injection for intravenous use. It treats metastatic colorectal cancer and other solid tumours as part of combination chemotherapy regimens.

GNH India supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Fresenius Kabi Austria Gmbh

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Indications & Clinical Uses

Irinotecan is employed in oncology for cancers that are treated with topoisomerase I‑targeted chemotherapy.

  • Metastatic colorectal cancer: used in combination regimens to improve progression‑free and overall survival.
  • Other solid tumours: incorporated into multi‑agent chemotherapy protocols for disease control.
  • Advanced colorectal cancer after first‑line failure: administered to achieve tumour response in later‑line therapy.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the transient DNA‑topoisomerase I complex, it prevents religation of single‑strand DNA breaks, leading to accumulation of DNA damage, replication arrest and ultimately apoptotic cell death in rapidly dividing tumour cells.

Side Effects

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

Common Side Effects

  • Diarrhoea: often delayed and may be severe.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: typical chemotherapy‑related symptoms.
  • Fatigue: generalized tiredness during treatment cycles.
  • Alopecia: hair loss that may be temporary.
  • Abdominal pain: discomfort in the gastrointestinal tract.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe diarrhoea (colitis): can lead to dehydration and electrolyte imbalance.
  • Hepatic toxicity: elevated liver enzymes or jaundice.
  • Allergic reactions: rash, bronchospasm or anaphylaxis.
  • Secondary malignancies: rare risk of therapy‑related cancers.
  • Severe mucositis: painful inflammation of the mouth and gastrointestinal lining.

Precautions & Warnings

Prior to initiating Irinotecan therapy, several safety considerations should be addressed.

  • Monitor blood counts: perform regular complete blood counts to detect neutropenia.
  • Assess liver function: evaluate hepatic enzymes and bilirubin before each cycle.
  • Evaluate bowel status: avoid use in patients with recent bowel obstruction or perforation.
  • Dose adjustment: consider reduced dosing in patients with hepatic impairment.
  • Hypersensitivity: discontinue if signs of an allergic reaction appear.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan interacts with several drugs that may alter its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce SN‑38 exposure.
  • UGT1A1 inhibitors (e.g., atazanavir, indinavir): can increase SN‑38 levels and toxicity.
  • Concurrent myelosuppressive agents: heighten risk of severe neutropenia.

Moderate Interactions (Monitor Closely)

  • Antiemetics such as ondansetron: may affect SN‑38 metabolism.
  • Anticoagulants (e.g., warfarin): increased bleeding risk.
  • NSAIDs: may exacerbate gastrointestinal toxicity.
  • Proton pump inhibitors: potential impact on drug absorption and metabolism.

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent used primarily for the treatment of metastatic colorectal cancer and other solid tumours. It is administered as part of combination regimens to improve disease control and survival outcomes in patients with advanced cancer.

Irinotecan is a pro‑drug that is converted inside cells to SN‑38, which inhibits topoisomerase I. This enzyme normally relieves DNA supercoiling during replication. By blocking it, SN‑38 causes DNA strand breaks that cannot be repaired, leading to tumour cell death.

The dosing of Irinotecan Kabi is individualized and determined by the prescribing oncologist based on the specific cancer type, treatment protocol, patient weight, renal and hepatic function, and prior therapy. Exact regimens are not disclosed here.

Safety data for Irinotecan in pregnancy and lactation are limited, and the product is classified as contraindicated unless the potential benefit justifies the risk. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To request 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 import documentation.

Irinotecan is one of the most widely used topoisomerase I inhibitors and differs from agents such as topotecan in its chemical structure, conversion to the active metabolite SN‑38, and approved indications. Both share similar mechanisms, but Irinotecan is the standard of care for colorectal cancer, whereas topotecan is primarily used for ovarian and small‑cell lung cancers.

Irinotecan Kabi must be stored refrigerated at 2‑8 °C. The vial should be kept in its original packaging, protected from light, and should not be frozen or shaken. Once prepared for administration, it should be used promptly according to aseptic technique.

Irinotecan Kabi is supplied as a sterile solution for injection and is given intravenously, typically over 30‑90 minutes depending on the protocol. Administration is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions.

The most serious risks include severe neutropenia leading to infection, life‑threatening diarrhoea (colitis), febrile neutropenia, hepatic toxicity, and rare allergic reactions. Patients should be closely monitored for signs of infection, dehydration, liver dysfunction and hypersensitivity throughout treatment.

Irinotecan Kabi should not be used in patients with known hypersensitivity to irinotecan or any of its excipients, those with recent bowel obstruction or perforation, and individuals with severe hepatic impairment unless dose adjustments are made. Caution is also advised for patients with pre‑existing severe neutropenia.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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