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 powder for intravenous use. It treats certain advanced cancers in adult patients, most commonly metastatic colorectal cancer and relapsed small cell lung cancer.
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 Polska Sp. Z O.O.

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Indications & Clinical Uses

Irinotecan Kabi is employed in oncology regimens that target rapidly dividing tumor cells.

  • Metastatic colorectal cancer: improves survival when used in combination chemotherapy protocols.
  • Relapsed small cell lung cancer: provides disease control as a second‑line option.
  • Advanced gastrointestinal cancers: contributes to tumor reduction as part of multi‑agent therapy.

How It Works

  • Irinotecan Hydrochloride Trihydrate is a prodrug that is converted to SN‑38, a potent inhibitor of topoisomerase I. By stabilizing the transient DNA‑topoisomerase I complex, it prevents relegation of single‑strand DNA breaks, leading to accumulation of DNA damage, replication arrest, and ultimately apoptotic cell death in proliferating cancer cells.

Side Effects

Irinotecan Kabi may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Diarrhea: often severe and may require supportive care.
  • Nausea and vomiting: typical chemotherapy‑related symptoms.
  • Alopecia: temporary hair loss.
  • Fatigue: generalized tiredness.
  • Abdominal pain: discomfort in the stomach area.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils, a medical emergency.
  • Severe colitis: life‑threatening inflammation of the colon.
  • Cholinergic syndrome: sweating, salivation, and bradycardia.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Hepatic toxicity: elevated liver enzymes or jaundice.
  • Thromboembolic events: blood clots in veins or arteries.

Precautions & Warnings

Before initiating therapy with Irinotecan Kabi, several safety considerations are essential.

  • Dose adjustment: modify dosing in patients with hepatic impairment to avoid excess exposure.
  • Monitor blood counts: perform regular CBC tests to detect neutropenia early.
  • Assess renal function: adjust if severe renal dysfunction is present.
  • Avoid strong CYP3A4 inhibitors: concurrent use may increase drug levels and toxicity.
  • Pregnancy: prescribe only when potential benefits justify potential fetal risks.
  • 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 inhibitors (e.g., ketoconazole, itraconazole): may raise plasma concentrations.
  • UGT1A1 inhibitors (e.g., atazanavir): increase risk of severe neutropenia.
  • Concurrent myelosuppressive agents: amplify bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effect.
  • Warfarin: may enhance anticoagulant effect, requiring INR monitoring.

Frequently Asked Questions

Irinotecan Kabi is a chemotherapy agent indicated for the treatment of metastatic colorectal cancer and relapsed small cell lung cancer in adult patients, typically as part of combination regimens designed to improve survival and disease control.

Irinotecan Hydrochloride is converted in the body to the active metabolite SN‑38, which inhibits topoisomerase I. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to DNA damage, cell cycle arrest, and apoptosis of rapidly dividing cancer cells.

The prescribed dose of Irinotecan Kabi is determined by the treating oncologist based on the specific cancer type, patient body surface area, organ function, and prior therapies. Dosing regimens are individualized and should follow the prescriber’s instructions.

Safety of Irinotecan Kabi in pregnancy has not been established; it is generally contraindicated unless the potential benefit justifies the risk to the fetus. Breastfeeding is not recommended because the drug may be excreted in milk and could harm the infant.

To order Irinotecan Kabi, 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 and any required import documentation.

Compared with other topoisomerase I inhibitors, Irinotecan has a distinct toxicity profile, notably higher rates of severe diarrhea and neutropenia. It is often chosen when fluoropyrimidine‑based regimens are insufficient, while alternatives such as topotecan or newer targeted therapies may be preferred in different clinical contexts.

Irinotecan Kabi should be stored at 2‑8 °C, protected from light, and kept in its original container. It must not be frozen or shaken. Reconstitution should be performed using aseptic technique immediately before intravenous infusion.

Irinotecan Kabi is supplied as a sterile powder for intravenous infusion. After reconstitution with the appropriate diluent, it is administered over 30‑90 minutes under medical supervision, following the dosing schedule prescribed by the oncologist.

The most critical risks include severe neutropenia, febrile neutropenia, life‑threatening diarrhea (colitis), cholinergic syndrome, and hypersensitivity reactions. Patients should be monitored closely for signs of infection, dehydration, and allergic responses throughout treatment.

Patients with known hypersensitivity to Irinotecan or its excipients, those with severe hepatic impairment, uncontrolled infections, or a history of severe myelosuppression should avoid the drug. The prescribing physician must evaluate each individual’s suitability before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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