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 treats metastatic colorectal cancer and other solid tumors 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 S.R.O.

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Indications & Clinical Uses

Irinotecan is used in oncology to target cancers that rely on topoisomerase I activity.

  • Metastatic colorectal cancer: improves overall response rates when combined with fluoropyrimidine‑based regimens.
  • Advanced gastric cancer: used as part of combination chemotherapy to achieve tumor shrinkage.
  • Pancreatic adenocarcinoma: incorporated into multi‑agent protocols to extend progression‑free survival.

How It Works

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

Side Effects

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

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset occurring during or after infusion.
  • Diarrhea: often delayed, may require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: temporary hair loss during treatment cycles.
  • Fatigue: generalized tiredness affecting daily activities.

Serious or Rare Side Effects

  • Severe neutropenic fever: high fever with low neutrophil count requiring urgent care.
  • Acute cholinergic syndrome: abdominal cramps, sweating, and bradycardia.
  • Hepatotoxicity: elevated liver enzymes indicating liver stress.
  • Allergic reactions: rash, urticaria, or anaphylaxis in rare cases.

Precautions & Warnings

Before initiating Irinotecan therapy, clinicians should assess patient-specific risk factors and monitor laboratory parameters.

  • Baseline blood counts: obtain CBC to detect pre‑existing neutropenia.
  • Liver function: evaluate hepatic enzymes as Irinotecan metabolism is hepatic.
  • Renal function: adjust monitoring for patients with impaired clearance.
  • Concomitant medications: review for agents that may increase toxicity, such as CYP3A4 inhibitors.
  • Pregnancy and lactation: avoid use unless benefits clearly outweigh potential fetal or infant risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan interacts with several drug classes that can modify its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may increase SN‑38 exposure and toxicity.
  • UGT1A1 inhibitors (e.g., atazanavir): can elevate active metabolite levels, raising risk of neutropenia.
  • Anticholinergic agents: may exacerbate cholinergic syndrome.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): monitor INR as Irinotecan may affect coagulation.
  • Myelosuppressive chemotherapy (e.g., carboplatin): increase risk of severe bone‑marrow suppression.
  • Fluoropyrimidines (e.g., 5‑FU): require dose adjustments to manage overlapping toxicities.

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and selected other solid tumors such as gastric and pancreatic cancers. It is administered as part of combination regimens to improve tumor response and disease control.

Irinotecan is converted in the body to its active metabolite SN‑38, which inhibits topoisomerase I. This enzyme normally relieves torsional strain during DNA replication. By blocking topoisomerase I, SN‑38 prevents DNA strand religation, leading to DNA breaks, replication arrest, and cancer cell death.

The specific dose of Irinotecan Kabi is determined by the prescribing oncologist based on factors such as cancer type, treatment protocol, patient weight, and organ function. Dosing regimens are individualized and should follow the clinician’s written order.

Safety data for Irinotecan in pregnancy and lactation are limited. It is generally contraindicated unless the potential benefit to the mother outweighs the possible risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

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 if needed), and required import documentation.

Irinotecan is the most widely used topoisomerase I inhibitor in oncology, distinguished by its conversion to SN‑38 and its established efficacy in colorectal cancer. Other agents, such as topotecan, share a similar mechanism but differ in approved indications, dosing schedules, and toxicity profiles, making Irinotecan the preferred choice for colorectal and certain solid‑tumor regimens.

Irinotecan Kabi must be stored refrigerated at 2‑8 °C, protected from light, and should never be frozen or shaken. The product should be kept in its original packaging until use to maintain stability and potency.

Irinotecan Kabi is given as an intravenous infusion, typically over 30 to 90 minutes depending on the protocol. Administration is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions and vital signs.

The most serious risks include severe neutropenia with fever, delayed diarrhea that can become life‑threatening, cholinergic syndrome, and rare allergic reactions such as anaphylaxis. Prompt recognition and management of these events are essential to minimize complications.

Irinotecan Kabi is contraindicated in patients with known hypersensitivity to Irinotecan or any of its excipients, in those with severe bone‑marrow suppression, and in individuals with uncontrolled infections. Caution is also advised for patients with significant hepatic impairment or those taking strong CYP3A4 or UGT1A1 inhibitors.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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