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 a sterile powder for intravenous use. It is employed in the treatment of colorectal cancer and metastatic colorectal cancer in adult patients.

GNH India supplies Irinotecan Fresenius Kabi as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Fresenius Kabi Norge As

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Indications & Clinical Uses

  • Irinotecan is an antineoplastic agent used in colorectal cancer treatment pathways.
  • Colorectal cancer: improves survival when used in combination chemotherapy regimens.
  • Metastatic colorectal cancer: reduces tumor burden and extends progression‑free survival.
  • Adjuvant therapy for stage III colorectal cancer: administered after surgical resection to lower recurrence risk.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to DNA topoisomerase I and stabilises the enzyme‑DNA complex. This prevents the relegation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately tumor cell death.

Side Effects

Irinotecan may cause a range of adverse reactions.

Common Side Effects

  • Nausea and vomiting
  • Diarrhea, often severe
  • Neutropenia and other blood count reductions
  • Alopecia (hair loss)
  • Fatigue and weakness
  • Mild liver enzyme elevations

Serious or Rare Side Effects

  • Febrile neutropenia
  • Severe colitis or intestinal perforation
  • Hepatic toxicity with jaundice
  • Anaphylactic or severe allergic reactions
  • Tumor lysis syndrome
  • Life‑threatening electrolyte disturbances

Precautions & Warnings

Before initiating therapy, clinicians should evaluate patient‑specific risk factors.

  • Renal function: assess creatinine clearance and adjust if necessary.
  • Hepatic function: monitor liver enzymes and bilirubin levels.
  • Myelosuppression: perform baseline and periodic complete blood counts.
  • Diarrhea: initiate prophylactic loperamide and educate patients on early reporting.
  • Pregnancy: avoid use; potential fetal risk is unknown.
  • Store at controlled room temperature: keep in original container, protect from light and moisture.

Avoid Interactions

Irinotecan can interact with several drug classes, requiring careful management.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampicin) may markedly reduce exposure.
  • UGT1A1 inhibitors (e.g., atazanavir) can increase SN‑38 levels and toxicity.
  • Concurrent myelosuppressive agents may cause profound bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticoagulants: heightened bleeding risk due to mucosal injury.
  • Drugs causing electrolyte imbalance (e.g., diuretics) may exacerbate diarrhea‑related losses.
  • Radiation therapy to the abdomen: additive gastrointestinal toxicity.

Frequently Asked Questions

Irinotecan Fresenius Kabi is an intravenous chemotherapy used primarily for colorectal cancer, including metastatic disease, and as part of adjuvant regimens for stage III colon cancer. It is administered by qualified healthcare professionals as part of combination protocols designed to shrink tumors and improve survival outcomes.

After infusion, Irinotecan is metabolised to SN‑38, which binds to DNA topoisomerase I. This stabilises the transient DNA‑enzyme complex, preventing the re‑ligation of single‑strand breaks during replication. The resulting DNA damage triggers apoptosis in rapidly dividing cancer cells.

The dose of Irinotecan is individualized by the prescribing oncologist based on factors such as body surface area, disease stage, prior therapies, and organ function. The prescriber determines the exact amount, infusion rate, and schedule in accordance with clinical guidelines and patient tolerance.

Safety data for Irinotecan during pregnancy and lactation are limited, and the drug is classified as contraindicated in pregnant women because of potential fetal harm. Breastfeeding is not recommended while receiving Irinotecan, as the medication 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 any required import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, offering a different mechanism from agents such as oxaliplatin (a platinum compound) or 5‑fluorouracil (a pyrimidine analogue). In combination regimens, Irinotecan can provide synergistic tumor control, especially in patients who have progressed on oxaliplatin‑based therapy, but it may have a higher incidence of diarrhea and neutropenia.

Irinotecan should be stored at controlled room temperature, typically below 25 °C, in its original packaging to protect it from light and moisture. Once reconstituted, the solution must be used within the time frame specified in the product label and kept refrigerated if required by the preparation instructions.

Irinotecan is supplied as a sterile powder for intravenous infusion. It is reconstituted with a compatible diluent, filtered, and administered by slow infusion over 30‑90 minutes, depending on the protocol. Administration is performed by trained medical staff in a clinical setting equipped for infusion therapy.

The most serious adverse events include severe neutropenia with fever, life‑threatening diarrhea that can lead to dehydration or colitis, hepatic toxicity, and rare allergic reactions. Prompt monitoring of blood counts, gastrointestinal symptoms, and liver function tests is essential to mitigate these risks.

Irinotecan is contraindicated in patients with known hypersensitivity to the drug or its excipients, those with severe bone‑marrow suppression (e.g., neutrophil count <1500 µL), uncontrolled infections, or significant hepatic impairment. Caution is also advised for patients with a history of severe gastrointestinal disorders.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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