Product image of Irinotecan Fresenius Kabi (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotecan Fresenius Kabi

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Fresenius Kabi (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Fresenius Kabi, is a topoisomerase I inhibitor presented as an injection solution for intravenous infusion use. It is indicated for the treatment of metastatic colorectal cancer and other solid tumours as determined by an oncologist, and may be employed in adjuvant therapy following surgical resection of colon cancer.

GNH India supplies Irinotecan Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and specialty pharmacies worldwide, with distribution aligned to EU regulatory standards.

Manufacturer / TM Owner

Fresenius Kabi Ab

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Indications & Clinical Uses

  • Irinotecan is a topoisomerase I inhibitor used in chemotherapy regimens for colorectal and other solid tumours.
  • Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy.
  • Adjuvant therapy for colon cancer: reduces risk of disease recurrence after curative surgery.
  • Other solid tumours (as determined by oncologist): may be incorporated into combination regimens for selected cancers.

How It Works

  • Irinotecan is a pro‑drug that is enzymatically converted in the liver to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex and stabilises it, preventing the re‑ligation of single‑strand DNA breaks during replication. This inhibition leads to accumulation of DNA damage, triggering cell‑cycle arrest and apoptosis in rapidly dividing tumour cells.

Side Effects

Irinotecan may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Neutropenia: decreased white blood cell count increasing infection risk.
  • Diarrhoea: acute onset often within the first two weeks of treatment.
  • Nausea and vomiting: gastrointestinal upset common during infusion.
  • Alopecia: hair loss may occur during therapy.

Serious or Rare Side Effects

  • Severe neutropenia with fever (febrile neutropenia): life‑threatening infection risk.
  • Severe diarrhoea (colitis) leading to dehydration and electrolyte imbalance.
  • Hypersensitivity reactions: anaphylaxis or severe skin rash.

Precautions & Warnings

  • When using Irinotecan, clinicians should observe specific safety measures to minimise risks.
  • Assess baseline blood counts: obtain complete blood count before each cycle.
  • Monitor liver function: Irinotecan is metabolised hepatically, adjust for impairment.
  • Genotype UGT1A1 when possible: reduced activity increases SN‑38 exposure.
  • Avoid concurrent myelosuppressive agents unless necessary: may exacerbate bone‑marrow toxicity.
  • Educate patients on early signs of diarrhoea and neutropenia: prompt medical attention required.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan interacts with several drugs that can alter its efficacy or toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): markedly reduce SN‑38 formation and therapeutic effect.
  • UGT1A1 inhibitors (e.g., atazanavir, indinavir): increase SN‑38 levels, raising risk of severe neutropenia and diarrhoea.
  • Concurrent myelosuppressive chemotherapy (e.g., cyclophosphamide, doxorubicin): additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticholinergic agents (e.g., atropine, scopolamine): may worsen irinotecan‑induced diarrhoea.
  • Warfarin: potential alteration of anticoagulant effect, monitor INR.
  • Radiation therapy to abdomen/pelvis: may increase gastrointestinal toxicity.

Frequently Asked Questions

Irinotecan Fresenius Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer, for adjuvant therapy after surgical resection of colon cancer, and for selected other solid tumours as determined by an oncologist. It is administered as part of combination regimens to improve survival outcomes in these patient populations.

Irinotecan Hydrochloride Trihydrate is a pro‑drug that is converted in the liver to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I enzyme, stabilising the transient DNA break that the enzyme creates during replication. This prevents DNA re‑ligation, leading to accumulation of DNA damage, cell‑cycle arrest and ultimately tumour cell death.

The dosing regimen for Irinotecan is individualized by the treating oncologist based on factors such as the specific cancer type, treatment protocol, patient weight, performance status and organ function. The prescriber determines the appropriate dose, infusion rate and schedule, and may adjust it during therapy according to clinical response and laboratory monitoring.

The safety of Irinotecan during pregnancy and lactation has not been established. It is classified as contraindicated for use in pregnant women because of potential fetal toxicity, and breastfeeding is generally discouraged while receiving treatment, as the drug may be excreted in milk and affect the infant.

To place an order, submit an enquiry on the product page at gnhindia.com specifying the required quantity of Irinotecan Fresenius Kabi. 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 handling) and any necessary import documentation.

Irinotecan and topotecan are both topoisomerase I inhibitors, but Irinotecan is typically used for colorectal and certain other solid tumours, whereas topotecan is more common in small‑cell lung cancer and ovarian cancer. Irinotecan’s pro‑drug conversion to SN‑38 results in a distinct toxicity profile, with higher rates of severe diarrhoea and neutropenia compared with topotecan.

Irinotecan injection should be stored at 2‑8 °C in a refrigerator, protected from light. The solution must not be frozen or shaken. Prior to administration, it may be diluted with the appropriate diluent under aseptic conditions and used within the time frame recommended by the manufacturer.

Irinotecan is given as an intravenous infusion, usually over 30 to 90 minutes depending on the protocol. The drug is supplied as a sterile injection solution that is diluted with a compatible fluid before infusion. Administration is performed in a clinical setting where vital signs and infusion reactions can be monitored.

The most serious adverse events associated with Irinotecan include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhoea (colitis) that can lead to dehydration and electrolyte imbalance, and hypersensitivity reactions such as anaphylaxis. Prompt recognition and supportive care are essential to mitigate these risks.

Irinotecan is contraindicated in patients with known hypersensitivity to the drug or any of its excipients. It should be avoided in individuals with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment without dose adjustment. Caution is also advised for patients with known UGT1A1 deficiency, as they are at higher risk for toxicity.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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