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 employed in the treatment of colorectal cancer, metastatic colorectal cancer, and other solid tumours in adult patients.

GNH India supplies Irinotecan Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory documentation for global distribution, ensuring reliable access to essential oncology medicines.

Manufacturer / TM Owner

Fresenius Kabi Ab

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Indications & Clinical Uses

Irinotecan is a topoisomerase I inhibitor used in oncology for the management of specific solid‑tumour cancers.

  • Colorectal cancer: improves disease control when combined with fluoropyrimidine‑based chemotherapy.
  • Metastatic colorectal cancer: extends progression‑free survival as part of combination regimens.
  • Other solid tumours: provides therapeutic benefit in selected cases such as gastric or pancreatic cancer when standard options are limited.

How It Works

  • Irinotecan is a prodrug that is enzymatically converted to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, preventing the re‑ligation step of DNA replication. This inhibition leads to accumulation of DNA breaks, disruption of transcription, and ultimately triggers apoptosis of rapidly dividing cancer cells.

Side Effects

Irinotecan may cause a range of adverse reactions, varying in frequency and severity.

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset commonly reported during treatment.
  • Diarrhea: can be mild to moderate and may require antidiarrheal therapy.
  • Neutropenia: reduction in white blood cells increasing infection risk.
  • Fatigue: general tiredness often experienced by patients.

Serious or Rare Side Effects

  • Severe neutropenia or febrile neutropenia: may lead to life‑threatening infections.
  • Severe diarrhea or colitis: can result in dehydration and electrolyte imbalance.
  • Hepatic toxicity: elevated liver enzymes or jaundice.
  • Allergic reactions: including rash, bronchospasm, or anaphylaxis.
  • Electrolyte disturbances: such as hypokalemia or hyponatremia.

Precautions & Warnings

Before initiating Irinotecan therapy, several safety considerations should be observed.

  • Dose adjustment: required in patients with hepatic impairment to avoid excessive exposure.
  • Monitoring: perform regular complete blood counts to detect neutropenia early.
  • Hydration: maintain adequate fluid intake to reduce the risk of severe diarrhea.
  • Drug interactions: avoid concurrent use of strong CYP3A4 inhibitors that may increase SN‑38 levels.
  • Pregnancy and lactation: use only if the potential benefit justifies the potential risk; safety data are limited.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the vial.

Avoid Interactions

Irinotecan can interact with other medicines, influencing its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase SN‑38 exposure and toxicity.
  • UGT1A1 inhibitors (e.g., atazanavir): can reduce SN‑38 clearance, raising risk of neutropenia and diarrhea.
  • Concurrent myelosuppressive agents: may exacerbate bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampicin, carbamazepine): may lower drug levels, reducing effectiveness.
  • Anticoagulants (e.g., warfarin): monitor INR as Irinotecan may affect coagulation parameters.
  • Radiation therapy: increased risk of gastrointestinal toxicity when combined.

Frequently Asked Questions

Irinotecan Fresenius Kabi is an intravenous chemotherapy used primarily for the treatment of colorectal cancer, metastatic colorectal cancer, and selected solid tumours such as gastric or pancreatic cancer. It is administered as part of combination regimens to improve disease control and extend progression‑free survival in adult patients.

Irinotecan is a prodrug that is converted in the body to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I enzyme, preventing the re‑ligation of single‑strand DNA breaks during replication. This results in accumulation of DNA damage, inhibition of transcription, and ultimately triggers apoptosis of rapidly dividing cancer cells.

The dose of Irinotecan is individualized by the prescribing oncologist based on factors such as the specific cancer type, treatment regimen, patient body‑surface area, and organ function. Dosing schedules may vary, and adjustments are often made according to laboratory results and tolerability.

Safety data for Irinotecan during pregnancy and lactation are limited. It is classified as contraindicated unless the potential therapeutic benefit justifies the potential risk to the fetus or infant. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss risks with their healthcare provider.

To place an order, submit an enquiry on the Irinotecan Fresenius Kabi product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials. The team then replies with pricing, availability, shipping details (including cold‑chain handling if needed) and required import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as topotecan or anthracyclines that target other cellular mechanisms. Compared with topotecan, Irinotecan generally has a broader indication in colorectal cancer and may be used in combination with fluoropyrimidines, offering distinct efficacy and toxicity profiles that influence regimen selection.

Irinotecan injection solution should be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and do not freeze or shake vigorously. Before use, allow the product to reach room temperature if required, and follow aseptic techniques for preparation and administration.

Irinotecan is administered by intravenous infusion, typically over 30 to 90 minutes depending on the protocol. The infusion is prepared in a sterile diluent, and dosing is calculated by the treating physician. Administration is performed in a clinical setting where vital signs and infusion reactions can be monitored.

The most serious adverse events include severe neutropenia or febrile neutropenia, which can predispose to life‑threatening infections, and severe diarrhea or colitis that may cause dehydration and electrolyte imbalance. Hepatic toxicity and rare allergic reactions such as anaphylaxis are also important to monitor closely during therapy.

Irinotecan is contraindicated in patients with known hypersensitivity to the drug or any of its components, and in those with severe hepatic impairment where drug clearance is markedly reduced. Caution is also advised for individuals with pre‑existing severe bone‑marrow suppression or uncontrolled infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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