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

Irinotecan Fresenius Kabi

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Fresenius Kabi (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Fresenius Kabi, is a topoisomerase I inhibitor presented as an injectable solution for intravenous administration. It is employed in the treatment of metastatic colorectal cancer and other solid tumours, typically as part of multi‑drug chemotherapy protocols designed for adult patients.

GNH India supplies Irinotecan Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to hospitals, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and offers global logistics support.

Manufacturer / TM Owner

Fresenius Kabi Limited

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Indications & Clinical Uses

  • Irinotecan is a topoisomerase I inhibitor used in chemotherapy regimens for colorectal and other solid tumours.
  • Metastatic colorectal cancer: improves survival when combined with fluoropyrimidine and oxaliplatin.
  • Advanced colorectal cancer: used after failure of first‑line therapy to achieve disease control.
  • Other solid tumours: incorporated into combination protocols for gastric, pancreatic and lung cancers.
  • Locally advanced colorectal cancer: employed to downstage tumours before surgical resection.

How It Works

  • Irinotecan is converted in vivo to its active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex and stabilises it, preventing relegation of single‑strand DNA breaks. This results in accumulation of DNA damage, inhibition of DNA replication and transcription, and ultimately triggers apoptotic cell death in rapidly dividing cancer cells.

Side Effects

Irinotecan may cause a range of adverse reactions, from mild to life‑threatening.

Common Side Effects

  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Diarrhoea: can be severe and require supportive care.
  • Nausea and vomiting: often managed with anti‑emetics.
  • 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 diarrhoea (colitis): may lead to dehydration and electrolyte imbalance.
  • Allergic reactions: rash, bronchospasm or anaphylaxis.
  • Pulmonary toxicity: interstitial pneumonitis or fibrosis.
  • Tumour lysis syndrome: metabolic disturbances from rapid tumour cell breakdown.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.

Precautions & Warnings

  • Before initiating Irinotecan therapy, clinicians should assess several safety parameters.
  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess liver function: adjust dosing in hepatic impairment.
  • Hydration: maintain adequate fluids to reduce risk of severe diarrhoea.
  • Avoid concurrent strong CYP3A4 inhibitors: may increase drug exposure.
  • Pregnancy: use only if potential benefits justify potential fetal risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan interacts with several medicines that can alter its efficacy or toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase toxicity.
  • UGT1A1 inhibitors (e.g., atazanavir): raise active metabolite levels.
  • Concurrent myelosuppressive agents: heightened bone‑marrow suppression.
  • Live vaccines: increased risk of infection.

Moderate Interactions (Monitor Closely)

  • Fluoropyrimidines (e.g., 5‑FU): monitor for additive gastrointestinal toxicity.
  • Platinum compounds (e.g., oxaliplatin): watch for cumulative myelosuppression.

Frequently Asked Questions

Irinotecan Fresenius Kabi is an injectable chemotherapy agent indicated for the treatment of metastatic and advanced colorectal cancer, as well as for other solid tumours when used in combination with other anticancer drugs. It is part of standard regimens aimed at slowing disease progression and improving survival in adult oncology patients.

After intravenous administration, Irinotecan is metabolised to SN‑38, an active compound that binds to the DNA‑topoisomerase I complex. This binding prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage, inhibition of tumour cell replication, and ultimately programmed cell death.

The dose of Irinotecan is individualized by the prescribing oncologist based on factors such as the specific cancer type, treatment protocol, patient weight, renal and hepatic function, and prior therapy. Only a qualified healthcare professional can determine the appropriate dosing schedule.

Safety data for Irinotecan in pregnancy and lactation are limited. It is generally classified as contraindicated during pregnancy unless the potential benefit justifies the risk to the fetus. Breastfeeding is not recommended while receiving Irinotecan because the drug may be excreted in milk and could harm the infant.

To place an order, submit an enquiry on the Irinotecan Fresenius Kabi 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 any required import documentation.

Irinotecan is a pro‑drug that requires metabolic activation to SN‑38, whereas other topoisomerase I inhibitors such as topotecan are administered in active form. Irinotecan is commonly used in colorectal cancer regimens, while topotecan is often employed for ovarian and small‑cell lung cancers. Differences in pharmacokinetics, toxicity profiles and approved indications guide the choice between them.

Irinotecan injectable solution must be stored refrigerated at 2‑8 °C. It should be kept in its original container, protected from light, and must not be frozen or shaken. Prior to administration, the solution should be inspected for particulate matter and used within the time frame recommended by the manufacturer.

Irinotecan is given as an intravenous infusion, typically over 30 to 90 minutes depending on the treatment protocol. The infusion is performed by qualified healthcare personnel in a clinical setting, with appropriate monitoring for infusion‑related reactions and supportive measures for anticipated side effects.

The most critical risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhoea or colitis, and rare allergic reactions such as anaphylaxis. Prompt recognition and management of these events are essential; patients should be educated to report fever, persistent vomiting, or severe abdominal pain immediately.

Irinotecan is contraindicated in patients with known hypersensitivity to the drug or its excipients, in those with severe hepatic impairment, and in individuals who are pregnant unless the therapeutic benefit outweighs the risk. Caution is also advised for patients with pre‑existing bone‑marrow suppression or uncontrolled infections.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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