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 a sterile injectable solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer 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 Kabi is a Topoisomerase I inhibitor used primarily in colorectal cancer therapy.
  • Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based chemotherapy.
  • Small cell lung cancer (second‑line): provides tumor control after failure of first‑line regimens.
  • Advanced pancreatic cancer (clinical trials): investigated as part of combination protocols to enhance response rates.

How It Works

  • Irinotecan is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the enzyme‑DNA cleavable complex, it prevents relaxation of super‑coiled DNA, thereby blocking DNA replication and transcription in rapidly dividing cancer cells and leading to cell death.

Side Effects

Irinotecan Kabi is associated with a range of adverse reactions.

Common Side Effects

  • Nausea and vomiting: frequent gastrointestinal upset during and after infusion.
  • Diarrhea: may be severe and require antidiarrheal therapy.
  • Neutropenia: reduced white‑blood‑cell count increasing infection risk.
  • Fatigue: generalised tiredness often reported by patients.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count, a medical emergency.
  • Severe colitis: intense inflammation of the colon leading to dehydration.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis during infusion.
  • Hepatic toxicity: elevated liver enzymes indicating liver injury.
  • Pulmonary toxicity: interstitial pneumonitis or fibrosis in rare cases.

Precautions & Warnings

  • Prior to initiating Irinotecan therapy, several safety considerations are recommended.
  • Dose adjustment in hepatic impairment: reduce dose based on liver function tests.
  • Monitor blood counts regularly: weekly complete blood count during treatment cycles.
  • Assess renal function: evaluate creatinine clearance before each dose.
  • Avoid in patients with known hypersensitivity to irinotecan or formulation excipients.
  • Pregnancy and breastfeeding: safety not established; use only if benefits outweigh risks.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): markedly reduce irinotecan exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): increase SN‑38 levels and toxicity.
  • Concurrent myelosuppressive agents: amplify risk of severe bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs: may worsen constipation associated with irinotecan.
  • Warfarin: monitor INR as irinotecan can affect anticoagulant control.
  • Fluoropyrimidines (e.g., 5‑FU): increase gastrointestinal toxicity when used together.

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer. It is typically used in combination with other cytotoxic drugs to improve survival outcomes in adult patients.

The drug is converted inside cancer cells to the active metabolite SN‑38, which inhibits topoisomerase I. This prevents DNA strand relaxation, blocking replication and transcription, ultimately leading to tumor‑cell death.

The dosing regimen for Irinotecan Kabi is determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Specific dose information should be obtained from the treating physician.

Safety of Irinotecan Kabi in pregnancy and lactation has not been established. It should be used only if the potential benefit justifies the potential risk to the fetus or infant, and the decision must be made by the healthcare provider.

To place an order, submit an enquiry on the product page at gnhindia.com with 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 import documentation.

Irinotecan is a widely used Topoisomerase I inhibitor with a well‑characterised safety profile. Compared with agents such as topotecan, irinotecan generally offers a broader spectrum of activity in colorectal cancer but may have a higher incidence of gastrointestinal toxicity, requiring specific supportive care.

Irinotecan Kabi must be stored refrigerated at 2‑8 °C, protected from light, and should not be frozen or shaken. Prior to administration, the product should be inspected for particulate matter and used within the time frame specified by the manufacturer.

The medication is given by intravenous infusion, usually over 30 to 90 minutes depending on the treatment protocol. Administration is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions.

The most serious adverse events include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, and hypersensitivity reactions that can lead to anaphylaxis. Prompt medical attention is required if any of these symptoms occur.

Patients with known hypersensitivity to irinotecan or any of its excipients, those with severe hepatic impairment, and individuals who are pregnant or breastfeeding without a clear benefit‑risk assessment should avoid using Irinotecan Kabi. Final eligibility is determined by the treating physician.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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