Product image of Irinotekan Viatris (Irinotecan Hydrochloride Trihydrate) supplied by GNH India

Irinotekan Viatris

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotekan Viatris (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotekan Viatris, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous use. It treats metastatic colorectal cancer and colorectal adenocarcinoma in adult patients.

GNH India supplies Irinotekan Viatris as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Viatris Limited

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Indications & Clinical Uses

Irinotekan is indicated for malignant conditions of the colorectal tract, where inhibition of topoisomerase I is a therapeutic strategy.

  • Metastatic colorectal cancer: administered as part of combination chemotherapy to prolong survival and control tumor growth.
  • Colorectal adenocarcinoma: used in patients with advanced disease to reduce tumor burden and improve response rates.
  • Colorectal cancer (any stage) in combination regimens: incorporated with fluoropyrimidines and oxaliplatin to enhance cytotoxic effect.

How It Works

  • Irinotecan is a pro‑drug converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By binding to the DNA‑topoisomerase I complex, it prevents the religation of single‑strand breaks during DNA replication, leading to accumulation of DNA damage, replication arrest and ultimately apoptotic cell death in rapidly dividing tumor cells. The selective accumulation of SN‑38 in tumor tissue enhances its antineoplastic activity while sparing most normal cells.

Side Effects

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

Common Side Effects

  • Diarrhea: frequent, often severe watery stools.
  • Nausea and vomiting: gastrointestinal upset requiring anti‑emetic support.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: hair loss affecting scalp and body hair.

Serious or Rare Side Effects

  • Severe neutropenic sepsis: life‑threatening infection due to profound neutropenia.
  • Febrile neutropenia: fever accompanying low neutrophil counts.
  • Acute cholinergic syndrome: abdominal cramping, sweating, and bradycardia.

Precautions & Warnings

When using Irinotekan, clinicians should observe several safety measures to minimize risk.

  • Baseline blood counts: obtain complete blood count before each cycle to monitor hematologic toxicity.
  • Liver function monitoring: assess hepatic enzymes because SN‑38 metabolism occurs in the liver.
  • Hydration status: ensure adequate fluid intake to reduce risk of severe diarrhea.
  • Concomitant medications: avoid drugs that inhibit UGT1A1, which can increase SN‑38 exposure.
  • Pregnancy and lactation: contraindicated unless benefits outweigh risks; limited data available.
  • Store at 2‑8 °C: keep refrigerated, protect from light, do not freeze or shake the solution.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong UGT1A1 inhibitors (e.g., atazanavir): may raise SN‑38 levels and increase toxicity.
  • CYP3A4 inducers (e.g., rifampicin): can reduce SN‑38 formation, lowering antitumor effect.
  • High‑dose irinotecan with other topoisomerase I inhibitors: additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin, DOACs): increased bleeding risk due to mucosal damage from diarrhea.
  • Antimicrobials causing diarrhea (e.g., clindamycin): may exacerbate gastrointestinal toxicity.
  • Granulocyte colony‑stimulating factors (G‑CSF): may be used to manage neutropenia but require dose adjustments.

Frequently Asked Questions

Irinotekan is a brand of irinotecan hydrochloride used primarily in the treatment of metastatic colorectal cancer and colorectal adenocarcinoma. It is administered as part of combination chemotherapy regimens to help control tumor growth and improve survival outcomes in adult patients with advanced disease.

Irinotecan is a pro‑drug that is converted inside cells to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex, preventing the religation of single‑strand DNA breaks during replication. This leads to accumulation of DNA damage, replication arrest and ultimately triggers apoptosis of rapidly dividing cancer cells.

The dose of Irinotekan is individualized by the prescribing oncologist based on factors such as the patient’s body surface area, disease stage, prior therapies and laboratory values. The prescriber determines the appropriate infusion schedule and any dose adjustments needed for safety.

Safety data for Irinotekan during pregnancy and lactation are limited. Because the drug can cross the placenta and may be excreted in breast milk, it is generally avoided unless the potential benefit to the mother outweighs the potential risk to the fetus or infant. Consultation with a specialist is essential.

To order Irinotekan, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials. The team then replies with pricing, availability, shipping details (including cold‑chain if required) and any necessary import documentation.

The primary alternative to irinotecan in colorectal cancer regimens is topotecan, another topoisomerase I inhibitor, though it is less commonly used for this indication. Irinotecan generally offers a broader evidence base for metastatic colorectal cancer and is often combined with fluoropyrimidines and oxaliplatin, providing a more established efficacy profile compared with newer agents.

Irinotekan must be stored at 2‑8 °C in a refrigerator, protected from light. The solution should not be frozen or shaken. Before preparation, keep the vial in its original packaging and handle with aseptic technique to maintain sterility.

Irinotekan is administered by intravenous infusion. The drug is diluted in an appropriate compatible IV fluid and infused over a period that may range from 30 minutes to several hours, depending on the prescribed regimen and patient tolerance. Administration is performed under medical supervision in an oncology setting.

The most serious risks include severe neutropenia that can lead to life‑threatening infections, febrile neutropenia, and severe diarrhea that may cause dehydration and electrolyte imbalance. Acute cholinergic syndrome, characterized by abdominal cramping, sweating and bradycardia, is also a rare but critical adverse event requiring immediate medical attention.

Irinotekan should not be used in patients with known hypersensitivity to irinotecan or any of its excipients. It is also contraindicated in individuals with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment that would impair SN‑38 metabolism. Caution is advised for pregnant or breastfeeding women.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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