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 treats metastatic colorectal cancer and is used as adjuvant therapy for colon cancer in adult patients.

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

Manufacturer / TM Owner

Fresenius Kabi Ab

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Indications & Clinical Uses

Irinotecan acts on the DNA replication pathway in colorectal malignancies and is employed in several therapeutic settings.

  • Metastatic colorectal cancer: improves survival when combined with fluoropyrimidine‑based regimens.
  • Adjuvant therapy for colon cancer: reduces risk of disease recurrence after surgical resection.
  • Colorectal and colon cancer: used as part of combination chemotherapy protocols for advanced disease.

How It Works

  • After intravenous administration, irinotecan is converted intracellularly to the active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex and prevents re‑ligation of single‑strand DNA breaks, leading to accumulation of DNA damage and apoptosis of rapidly dividing tumor cells.

Side Effects

Irinotecan is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Nausea and vomiting: may be mitigated with anti‑emetics.
  • Neutropenia: reduced white‑blood‑cell count increasing infection risk.
  • Alopecia: temporary hair loss.
  • Fatigue: generalized tiredness.
  • Anorexia: loss of appetite.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count.
  • Severe colitis or intestinal perforation.
  • Hepatic toxicity: elevated liver enzymes or jaundice.
  • Allergic reactions including anaphylaxis.
  • Severe electrolyte disturbances.
  • Cardiotoxicity: rare but reported cases of arrhythmia.

Precautions & Warnings

Careful monitoring and dose adjustments are required to minimise toxicity.

  • Dose adjustment: required for patients with hepatic impairment.
  • Monitoring: regular CBC and liver‑function tests are recommended.
  • Pregnancy: contraindicated; classified as Category D, avoid use in pregnant women.
  • Drug interactions: avoid concurrent strong CYP3A4 inhibitors.
  • Administration: infusion should be administered over 90 minutes to reduce acute toxicity.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with several drug classes, influencing its efficacy and safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase SN‑38 exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia.
  • Concurrent use with other topoisomerase I inhibitors: additive cytotoxicity.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): may enhance bleeding risk.
  • Nephrotoxic agents (e.g., cisplatin): monitor renal function.
  • Radiation therapy: may increase gastrointestinal toxicity.

Frequently Asked Questions

Irinotecan Fresenius Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and as adjuvant therapy for colon cancer after surgical resection. It is administered by qualified healthcare professionals as part of a combination regimen.

After infusion, irinotecan is metabolised to SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately causing tumor‑cell death.

The specific dose of Irinotecan Fresenius Kabi is determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Dosing regimens are individualized and should follow the latest clinical guidelines.

Irinotecan is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It is contraindicated in pregnant women and should not be used while breastfeeding because it can be excreted in milk and may harm the infant.

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 import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines or oxaliplatin. It is often combined with these agents to enhance response rates. Compared with other topoisomerase inhibitors, irinotecan has a well‑characterised toxicity profile that includes notable diarrhea and neutropenia.

Irinotecan Fresenius Kabi should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. Prior to use, the solution should be inspected for particulate matter and any discoloration before administration.

The medication is supplied as an injectable solution for intravenous infusion. It is typically infused over a period of 90 minutes under medical supervision, with appropriate pre‑medication to manage nausea, vomiting and other infusion‑related reactions.

The most serious adverse events include severe neutropenia, febrile neutropenia, life‑threatening diarrhea or colitis, intestinal perforation, and rare allergic reactions such as anaphylaxis. Patients should be monitored closely for signs of infection, gastrointestinal toxicity and hepatic dysfunction.

Irinotecan is contraindicated in patients with known hypersensitivity to the drug or its excipients, in pregnant women, and in individuals with severe hepatic impairment without dose adjustment. Caution is also advised for patients with pre‑existing bone‑marrow suppression or uncontrolled infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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