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, the active ingredient in Irinotecan Kabi, is a topoisomerase I inhibitor presented as an injectable solution for intravenous infusion. It is employed in the treatment of colorectal cancer and metastatic colorectal cancer, primarily in adult oncology patients requiring systemic chemotherapy.

GNH India supplies Irinotecan Kabi as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, oncology centres, and pharmacies worldwide with consistent quality, regulatory compliance and reliable logistics support globally.

Manufacturer / TM Owner

Fresenius Kabi Polska Sp. Z O.O.

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Indications & Clinical Uses

Irinotecan Kabi is indicated for colorectal malignancies and is incorporated into established chemotherapy protocols.

  • Colorectal cancer (first‑line): combined with fluorouracil and leucovorin to increase tumor response and improve resection rates.
  • Metastatic colorectal cancer (second‑line): administered after progression on first‑line therapy to extend progression‑free survival.
  • Colorectal cancer (adjuvant): given post‑surgery to reduce the risk of disease recurrence in high‑risk patients.
  • Advanced colorectal cancer (palliative): used to alleviate symptoms and control tumor growth.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilizing the enzyme‑DNA cleavable complex, SN‑38 prevents relegation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately tumor cell apoptosis. Its activity is enhanced in tumors with low expression of the metabolizing enzyme UGT1A1, which can affect drug clearance.

Side Effects

Irinotecan Kabi may cause a spectrum of adverse reactions, ranging from common, manageable events to serious, potentially life‑threatening conditions.

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset that may require antiemetic therapy.
  • Diarrhea: frequent loose stools often occurring early in treatment.
  • Fatigue: generalized tiredness affecting daily activities.
  • Neutropenia: reduced white blood cell count increasing infection susceptibility.

Serious or Rare Side Effects

  • Severe neutropenia with fever: risk of life‑threatening infection requiring hospitalization.
  • Severe diarrhea (colitis): can lead to dehydration, electrolyte imbalance, and may need intensive care.
  • Allergic reactions: anaphylaxis or severe hypersensitivity requiring immediate medical intervention.

Precautions & Warnings

When prescribing Irinotecan Kabi, clinicians should observe several precautionary measures to ensure patient safety.

  • Monitor blood counts: perform regular CBC to detect neutropenia early.
  • Assess liver function: adjust therapy in patients with hepatic impairment.
  • Evaluate renal function: consider dose modification for renal insufficiency.
  • Avoid concurrent strong CYP3A4 inhibitors: may increase irinotecan exposure and toxicity.
  • Educate patients on early signs of diarrhea and infection: prompt reporting is essential.
  • 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 toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may raise irinotecan plasma levels.
  • UGT1A1 inhibitors (e.g., atazanavir): increase risk of severe neutropenia and diarrhea.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin): monitor INR for bleeding risk.
  • Other myelosuppressive agents: increase risk of bone‑marrow suppression.
  • Antidiarrheal agents (loperamide) used excessively: may mask severity of irinotecan‑induced diarrhea.

Frequently Asked Questions

Irinotecan Kabi is used as a systemic chemotherapy agent for the treatment of colorectal cancer and metastatic colorectal cancer. It is administered as part of combination regimens to improve tumor response, control disease progression, and, in some settings, reduce the risk of recurrence after surgery.

Irinotecan is a pro‑drug that is metabolised inside cancer cells to SN‑38, which inhibits topoisomerase I. By preventing the religation of single‑strand DNA breaks during replication, SN‑38 causes accumulation of DNA damage, leading to apoptosis of rapidly dividing tumor cells.

The dose of Irinotecan Kabi is individualized and determined by the prescribing oncologist based on factors such as the treatment regimen, patient weight, organ function, and prior therapy. No fixed dosing schedule can be provided without a medical prescription.

Safety data for Irinotecan in pregnancy and lactation are limited. Because potential risks to the fetus or infant cannot be excluded, the drug is generally avoided in pregnant or nursing women unless the potential benefit justifies the potential risk.

To order Irinotecan Kabi, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies 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 belongs to the topoisomerase I inhibitor class, whereas alternatives such as oxaliplatin are DNA cross‑linking agents. Both are used in colorectal cancer regimens, but they differ in toxicity profiles; irinotecan is more associated with diarrhea and neutropenia, while oxaliplatin commonly causes peripheral neuropathy.

Irinotecan Kabi should be stored refrigerated at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the solution. If the product must be transported, maintain the cold‑chain to preserve stability.

Irinotecan Kabi is given as an intravenous infusion. The solution is diluted in an appropriate compatible fluid and infused over a period defined by the treating physician, usually ranging from 30 minutes to several hours, depending on the prescribed regimen.

The most serious adverse events include severe neutropenia with fever, which can lead to life‑threatening infections, and severe diarrhea or colitis that may cause dehydration and electrolyte disturbances. Immediate medical attention is required if these symptoms develop.

Patients with known hypersensitivity to irinotecan or any component of the formulation should avoid the drug. It is also contraindicated in individuals with severe hepatic impairment, uncontrolled infections, or those receiving strong CYP3A4 or UGT1A1 inhibitors that cannot be safely managed.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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