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

Irinotecano Farmoz

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecano Farmoz (Irinotecan Hydrochloride Trihydrate)

Irinotecan, the active ingredient in Irinotecano Farmoz, is a topoisomerase I inhibitor presented as a sterile lyophilized powder for intravenous use. It is employed in oncology protocols to treat colorectal cancer and other solid tumours in adult patients. The drug is indicated for use in combination chemotherapy regimens and is manufactured according to European Union quality standards.

GNH India supplies Irinotecano Farmoz as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and specialty pharmacies worldwide, with a focus on reliable cold‑chain logistics and regulatory compliance.

Manufacturer / TM Owner

Farmoz - Sociedade Técnico Medicinal, S.A.

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Indications & Clinical Uses

Irinotecan is used in chemotherapy regimens targeting colorectal cancer and other solid tumours.

  • Colorectal cancer: improves response rates and overall survival when combined with fluoropyrimidine‑based regimens.
  • Gastric cancer: used in combination protocols to enhance tumour control.
  • Pancreatic cancer: incorporated into multi‑agent regimens for disease management.
  • Non‑small cell lung cancer: added to standard chemotherapy to increase efficacy.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the transient DNA‑topoisomerase I complex, SN‑38 prevents relegation of single‑strand breaks, leading to accumulation of DNA damage and inhibition of replication in rapidly dividing cancer cells. The active metabolite is primarily eliminated by hepatic glucuronidation via UGT1A1, and its cytotoxic effect is most pronounced during the S‑phase of the cell cycle.

Side Effects

Irinotecan may cause a range of adverse reactions, which are classified by frequency and severity.

Common Side Effects

  • Neutropenia: reduced white blood cell count leading to infection risk.
  • Diarrhea: frequent loose stools that may require supportive care.
  • Nausea and vomiting: gastrointestinal upset commonly observed during treatment.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils requiring urgent medical attention.
  • Severe colitis (ileocolitis): intense abdominal pain and bloody diarrhea.
  • Allergic reactions: rash, bronchospasm or anaphylaxis in susceptible patients.

Precautions & Warnings

Before initiating Irinotecano Farmoz, clinicians should observe several precautionary measures to minimise toxicity.

  • Monitor blood counts: perform regular complete blood count assessments to detect neutropenia early.
  • Assess liver function: evaluate hepatic enzymes because impaired metabolism increases SN‑38 exposure.
  • Evaluate bowel health: screen for pre‑existing diarrhoea or intestinal obstruction before treatment.
  • Adjust dose in hepatic or renal impairment: consider reduced dosing in patients with significant organ dysfunction.
  • Avoid use in known hypersensitivity: discontinue if severe allergic reaction occurs.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan can interact with other medicines, altering its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce SN‑38 levels and therapeutic effect.
  • UGT1A1 inhibitors (e.g., atazanavir, indinavir): increase SN‑38 exposure and risk of severe neutropenia or diarrhea.
  • Concurrent myelosuppressive agents (e.g., high‑dose cyclophosphamide): can exacerbate bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): enhanced bleeding risk due to potential liver enzyme interactions.
  • Antidiarrheal agents (e.g., loperamide): may mask early signs of irinotecan‑induced diarrhea.
  • Other topoisomerase inhibitors: additive toxicity may require dose adjustments.

Frequently Asked Questions

Irinotecano Farmoz contains irinotecan, a chemotherapy agent indicated for the treatment of colorectal cancer and a range of other solid tumours such as gastric, pancreatic and non‑small cell lung cancer, usually as part of combination regimens prescribed by an oncologist.

Irinotecan is a pro‑drug that is converted inside cancer cells to the active metabolite SN‑38. SN‑38 binds to topoisomerase I and stabilises the enzyme‑DNA complex, preventing DNA resealing, which leads to accumulation of DNA breaks and ultimately cell death during replication.

The dose of Irinotecano Farmoz is individualized by the treating physician based on factors such as the specific cancer type, treatment protocol, patient body surface area, organ function and prior therapy. No fixed dosing schedule is provided here; the prescriber sets the regimen.

There are no adequate clinical data on the use of irinotecan in pregnant or nursing women. Because of potential fetal toxicity and drug excretion in breast milk, the product is generally avoided unless the potential benefit justifies the risk, and it should be used only under specialist guidance.

To place an order, submit an enquiry on the Irinotecano Farmoz 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 where required) and any necessary import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class and offers a distinct mechanism compared with agents such as oxaliplatin or taxanes. In colorectal cancer, irinotecan‑based regimens have demonstrated comparable or superior response rates to some alternatives, especially when combined with fluoropyrimidines, but the choice depends on disease stage, patient tolerance and prior treatments.

Irinotecano Farmoz should be stored at 2‑8 °C in a refrigerator, protected from light. The product must not be frozen or shaken. Once reconstituted, it should be used according to the manufacturer’s stability guidelines and discarded if any discoloration or particulate matter is observed.

The medication is supplied as a sterile lyophilized powder for intravenous infusion. It is reconstituted with the appropriate diluent, then administered by a qualified healthcare professional through a controlled IV infusion, typically over 30‑90 minutes, following the dosing schedule prescribed by the oncologist.

The most critical adverse events include febrile neutropenia, severe diarrhoea or colitis that can lead to dehydration and electrolyte imbalance, and rare but life‑threatening allergic reactions such as anaphylaxis. Prompt medical evaluation is required if fever, persistent diarrhea, abdominal pain or signs of hypersensitivity 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 bone‑marrow suppression, uncontrolled infections, significant hepatic impairment, or pre‑existing intestinal obstruction, unless a specialist determines that benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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