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 an intravenous solution for intravenous use. It is employed in the treatment of 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. The company adheres to stringent quality standards and provides reliable logistics for global distribution. All shipments are handled under controlled temperature conditions where required, ensuring product integrity upon arrival.

Manufacturer / TM Owner

Fresenius Kabi Polska Sp. Z O.O.

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Indications & Clinical Uses

Irinotecan Kabi is a Topoisomerase I inhibitor used in oncology to target DNA replication in malignant cells.

  • Metastatic colorectal cancer: improves overall survival and tumor response when used in combination chemotherapy regimens.
  • Other solid tumors: provides antitumor activity in selected solid tumor types such as gastric and pancreatic cancers.
  • Combination therapy: enhances efficacy of fluoropyrimidine‑based regimens in advanced colorectal cancer.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This stabilizes the transient single‑strand breaks introduced during DNA replication, preventing relegation and leading to accumulation of DNA damage. The resulting inhibition of DNA synthesis and transcription triggers apoptosis in rapidly dividing tumor cells. The effect is cell‑cycle dependent, predominantly affecting cells in S‑phase, and contributes to tumor shrinkage observed clinically.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate nausea often occurring during or after infusion.
  • Diarrhea: acute onset watery diarrhea that may require antidiarrheal therapy.
  • Fatigue: generalized tiredness affecting daily activities.
  • Neutropenia: reduced neutrophil count increasing infection risk.

Serious or Rare Side Effects

  • Severe neutropenia: profound drop in white blood cells leading to febrile neutropenia.
  • Febrile neutropenia: fever accompanying low neutrophil levels, requiring urgent medical attention.
  • Severe diarrhea (colitis): may progress to dehydration and electrolyte imbalance.
  • Allergic reactions: anaphylaxis or severe hypersensitivity requiring immediate treatment.

Precautions & Warnings

Prior to using Irinotecan Kabi, clinicians should consider several safety measures.

  • Assess baseline blood counts: obtain a complete blood count to evaluate neutrophil and platelet levels.
  • Monitor liver function: evaluate hepatic enzymes as irinotecan metabolism is hepatic.
  • Adjust dose in hepatic impairment: consider dose reduction for patients with elevated bilirubin.
  • Avoid concurrent strong CYP3A4 inhibitors: these can increase SN‑38 exposure and toxicity.
  • Educate patients on diarrhea management: provide instructions for early use of antidiarrheal agents.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan Kabi interacts with several drugs that can modify its efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may raise SN‑38 levels and increase toxicity.
  • UGT1A1 inhibitors (e.g., atazanavir): can reduce SN‑38 clearance, heightening risk of neutropenia and diarrhea.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, phenytoin): may lower irinotecan exposure, reducing therapeutic effect.
  • Anticoagulants (e.g., warfarin): increased bleeding risk due to mucosal damage from diarrhea.
  • Other myelosuppressive agents: additive bone marrow suppression requiring close blood count monitoring.

Frequently Asked Questions

Irinotecan Kabi is indicated for the treatment of metastatic colorectal cancer and for selected other solid tumors. It is used as part of combination chemotherapy regimens to improve tumor response and overall survival in adult patients.

Irinotecan is converted inside cells to the active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to DNA damage, inhibition of transcription, and ultimately apoptosis of rapidly dividing cancer cells.

The dose of Irinotecan Kabi is individualized by the prescribing oncologist based on factors such as the patient’s body surface area, liver function, prior therapy, and the specific chemotherapy protocol being followed. No fixed dosing schedule is provided here.

The safety of Irinotecan in pregnancy and lactation has not been established. It is generally contraindicated during pregnancy because of potential fetal toxicity, and breastfeeding is not recommended while receiving treatment.

To place an order, submit an enquiry on the Irinotecan Kabi 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 necessary import documentation.

Irinotecan is a pro‑drug that requires metabolic activation to SN‑38, whereas other agents such as topotecan are administered in active form. Irinotecan is commonly used in colorectal cancer regimens, while topotecan is often employed for ovarian and small‑cell lung cancers. Both share a similar mechanism but differ in pharmacokinetics, toxicity profiles and approved indications.

Irinotecan Kabi should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to administration, the solution may be allowed to reach room temperature if required, but it should be used promptly after preparation.

Irinotecan Kabi is supplied as an intravenous solution that is administered by a healthcare professional through a controlled IV infusion. The infusion rate and duration are determined by the treating physician according to the selected chemotherapy protocol.

The most serious adverse reactions include severe neutropenia leading to febrile neutropenia, life‑threatening diarrhea or colitis, and rare but severe allergic reactions such as anaphylaxis. Prompt monitoring and supportive care are essential to manage these risks.

Patients with known hypersensitivity to irinotecan or any of its excipients, those with severe hepatic impairment, and individuals with active uncontrolled infections should not receive Irinotecan Kabi. Additionally, it is avoided in pregnancy and breastfeeding due to unknown safety.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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