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 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. The company adheres to stringent quality standards and provides cold‑chain logistics where required, ensuring product integrity from manufacturing to end‑user. Customers receive regulatory documentation and support for import clearance.

Manufacturer / TM Owner

Fresenius Kabi Italia S.R.L.

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Indications & Clinical Uses

Irinotecan Kabi is a topoisomerase I inhibitor employed in oncology regimens targeting gastrointestinal and thoracic malignancies.

  • Metastatic colorectal cancer: used in combination regimens to inhibit tumor growth and extend survival.
  • Small cell lung cancer: incorporated into multi‑drug chemotherapy to achieve tumor response and disease control.
  • Advanced gastric cancer: employed as part of multi‑agent protocols to manage disease progression.
  • Pancreatic cancer: used off‑label within combination therapy to attempt tumor reduction.
  • Ovarian cancer: occasionally combined with other agents in experimental protocols for disease management.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This binding stabilises the transient single‑strand breaks created during DNA replication, preventing relegation and leading to accumulation of DNA damage. The unrepaired breaks trigger apoptosis, particularly in rapidly proliferating tumour cells. The drug’s activity depends on cellular uptake, enzymatic conversion, and interaction with the topoisomerase I enzyme.

Side Effects

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

Common Side Effects

  • Diarrhea
  • Nausea
  • Neutropenia
  • Fatigue

Serious or Rare Side Effects

  • Severe neutropenia with fever
  • Life‑threatening colitis
  • Hypersensitivity reactions (anaphylaxis)

Precautions & Warnings

When using Irinotecan Kabi, clinicians should observe several precautionary measures to minimise risk.

  • Monitor blood counts: perform regular complete blood count assessments to detect neutropenia early.
  • Assess liver function: evaluate hepatic enzymes before and during therapy as impairment can increase exposure.
  • Evaluate gastrointestinal status: avoid use in patients with recent bowel obstruction or severe diarrhea.
  • Adjust for hypersensitivity: discontinue immediately if signs of an allergic reaction appear.
  • Dose modification in hepatic impairment: reduce dose according to liver function test results.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): markedly reduce irinotecan plasma levels.
  • Concurrent myelosuppressive agents: increase risk of severe neutropenia and thrombocytopenia.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may raise irinotecan exposure.
  • Anticoagulants such as warfarin: potential alteration of INR, requiring monitoring.
  • Drugs affecting biliary excretion (e.g., probenecid): could modify SN‑38 clearance.

Frequently Asked Questions

Irinotecan Kabi is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer in adult patients. It is typically administered as part of combination regimens such as FOLFIRI, where it works together with fluoropyrimidines and other agents to improve disease control and survival outcomes.

Irinotecan is a pro‑drug that is metabolised inside cells to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, stabilising the transient single‑strand breaks that occur during DNA replication. By preventing relegation of these breaks, the drug induces irreversible DNA damage, leading to apoptosis of rapidly dividing cancer cells.

The dosing regimen for Irinotecan Kabi is determined by the prescribing oncologist based on factors such as the patient’s body surface area, disease stage, and concurrent therapies. The prescriber calculates the appropriate milligram per square meter dose and schedules the intravenous infusion according to the selected treatment protocol.

The safety of Irinotecan Kabi in pregnancy and lactation has not been established. Animal studies have shown embryotoxic effects, and the drug is classified as contraindicated for use in pregnant or nursing women unless the potential benefit outweighs the potential risk. Consultation with a specialist is essential before exposure.

To place an order, visit the product page on gnhindia.com, enter the required quantity, and submit the enquiry form. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifying trade or institutional credentials before providing pricing, availability, shipping details—including cold‑chain logistics if needed—and the necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, whereas its primary alternative in colorectal cancer regimens is oxaliplatin, a platinum‑based DNA cross‑linker. Irinotecan primarily induces single‑strand DNA breaks, while oxaliplatin forms DNA adducts. Clinical choice depends on prior therapy, toxicity profile, and patient tolerance, as each agent has distinct efficacy and side‑effect considerations.

Irinotecan Kabi must be stored refrigerated at 2 °C to 8 °C, protected from light, and must not be frozen or shaken. The product should be kept in its original packaging until use, and any prepared infusion should be administered promptly according to aseptic technique to maintain stability and potency.

Irinotecan Kabi is supplied as an injectable solution for intravenous infusion. The medication is diluted in an appropriate carrier fluid and administered over a specified period, usually 30 to 90 minutes, under the supervision of qualified healthcare professionals. Infusion parameters are set according to the prescribing protocol and patient tolerance.

The most critical adverse events include severe neutropenia with fever, life‑threatening colitis or diarrhea, and hypersensitivity reactions that can progress to anaphylaxis. Prompt recognition of these signs, regular laboratory monitoring, and immediate medical intervention are essential to mitigate morbidity and mortality associated with the drug.

Irinotecan Kabi is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients, those with active severe infections, or individuals with recent bowel obstruction. Caution is also advised for patients with significant hepatic impairment, as drug clearance may be reduced, increasing the risk of toxicity.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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