Product image of Irinotecano Kabi (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotecano Kabi

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecano Kabi (Irinotecan Hydrochloride Trihydrate)

Irinotecan, the active ingredient in Irinotecano Kabi, is a topoisomerase I inhibitor presented as an intravenous formulation for use in cancer therapy. It is employed primarily in the treatment of colorectal malignancies, including metastatic disease, and as part of adjuvant regimens for colon cancer patients.

GNH India supplies Irinotecano Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Fresenius Kabi Pharma Portugal, Lda.

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Indications & Clinical Uses

Irinotecan is used in oncology to target cancers that rely on rapid DNA replication.

  • Colorectal cancer: improves survival when combined with standard chemotherapy regimens.
  • Metastatic colorectal cancer: provides disease control in patients with advanced disease.
  • Adjuvant therapy for colon cancer: reduces risk of recurrence after surgical resection.

How It Works

  • Irinotecan is a prodrug converted to SN‑38, which binds to the DNA‑topoisomerase I complex and stabilizes it, preventing the relegation of single‑strand DNA breaks. This inhibition blocks DNA unwinding during replication, leading to accumulation of DNA damage and ultimately tumor cell death.

Side Effects

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

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset commonly reported during treatment.
  • Diarrhea: may be severe and require supportive care.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: temporary hair loss during therapy.
  • Fatigue: generalized tiredness affecting daily activities.
  • Anemia: decreased red blood cell count causing weakness.

Serious or Rare Side Effects

  • Severe neutropenic infection: life‑threatening bacterial or fungal infections.
  • Febrile neutropenia: fever accompanying low neutrophil counts.
  • Acute cholinergic syndrome: abdominal cramping, sweating, and bradycardia.
  • Severe allergic reactions: anaphylaxis or hypersensitivity.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Cardiac toxicity: rare cases of arrhythmia or myocardial ischemia.

Precautions & Warnings

Before initiating Irinotecano Kabi, clinicians should assess patient suitability and monitor for potential complications.

  • Baseline blood counts: obtain complete blood count to detect pre‑existing cytopenias.
  • Liver function: evaluate hepatic enzymes as metabolism occurs hepatically.
  • Renal function: assess creatinine clearance for dose adjustment considerations.
  • Concomitant medications: review for agents that may increase toxicity, such as other myelosuppressive drugs.
  • Pregnancy and lactation: avoid use unless benefits clearly outweigh risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Irinotecan can interact with several drugs that affect its metabolism or toxicity profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin): may reduce efficacy by increasing clearance.
  • Anticholinesterase agents (e.g., neostigmine): can exacerbate cholinergic syndrome.
  • High‑dose corticosteroids: may increase risk of neutropenia.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole): may raise plasma levels.
  • Warfarin: monitor INR as bleeding risk may increase.
  • Other myelosuppressive chemotherapy: heightened bone‑marrow suppression.
  • Proton pump inhibitors: potential effect on gastric pH and absorption of oral formulations (if applicable).

Frequently Asked Questions

Irinotecano Kabi contains irinotecan, a chemotherapy agent indicated for the treatment of colorectal cancer, including metastatic disease, and as part of adjuvant therapy after surgical resection of colon cancer. It is used in oncology centres to improve disease control and survival outcomes.

Irinotecan is converted in the body to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. By stabilizing this complex, it prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and selective death of rapidly dividing tumor cells.

The dosing regimen for Irinotecano Kabi is determined by the prescribing oncologist based on the patient’s specific clinical situation, disease stage, body surface area, and prior treatment history. Healthcare professionals set the dose and schedule according to established oncology guidelines.

Irinotecan is classified as contraindicated in pregnancy unless the potential benefit justifies the risk to the fetus. It can cross the placenta and may cause fetal harm. Breastfeeding is not recommended during treatment because the drug may be excreted in milk and affect the infant.

To place an order, submit an enquiry on the 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 if needed), and necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from fluoropyrimidines or oxaliplatin. It is often combined with 5‑FU and leucovorin to enhance efficacy. Compared with agents like oxaliplatin, irinotecan may have a different toxicity profile, with more pronounced diarrhea and neutropenia but less peripheral neuropathy.

Irinotecano Kabi should be stored at 2‑8 °C in a refrigerator. Keep the vials in their original packaging, protect them from light, and avoid freezing or shaking the product to maintain stability and potency.

The drug is given by intravenous infusion under the supervision of qualified healthcare professionals. The infusion rate and duration are set by the treating physician, typically over 30 to 90 minutes, depending on the prescribed regimen and patient tolerance.

Serious risks include severe neutropenia leading to infection, febrile neutropenia, life‑threatening diarrhea, acute cholinergic syndrome, and rare but serious allergic reactions. Patients should be closely monitored for signs of infection, dehydration, and any hypersensitivity during treatment.

Patients with known hypersensitivity to irinotecan or its excipients, those with uncontrolled infections, severe bone‑marrow suppression, or significant hepatic impairment should not receive the drug. Additionally, it is avoided in pregnant women unless absolutely necessary and is contraindicated during breastfeeding.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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