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

Irinotecan Viatris

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Viatris (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Viatris, is a Topoisomerase I inhibitor presented as an injectable solution for intravenous use. It is employed in the treatment of colorectal cancer, metastatic colorectal cancer and other solid tumours.
GNH India supplies Irinotecan Viatris as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Viatris Limited

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Indications & Clinical Uses

  • Irinotecan Viatris is a topoisomerase I inhibitor used in oncology for several solid‑tumour indications.
  • Colorectal cancer: used as part of combination chemotherapy to control tumour growth.
  • Metastatic colorectal cancer: administered to improve disease control in advanced disease.
  • Other solid tumours: incorporated into regimens for various solid malignancies where topoisomerase I inhibition is indicated.

How It Works

  • Irinotecan is converted intracellularly to SN‑38, which binds to the DNA‑topoisomerase I complex and prevents relegation of single‑strand breaks. This stabilisation leads to accumulation of DNA breaks during replication, ultimately inhibiting DNA synthesis and triggering cell death in rapidly dividing cancer cells.

Side Effects

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

Common Side Effects

  • Diarrhoea: often delayed and may be severe.
  • Nausea and vomiting.
  • Neutropenia: reduced white blood cell count.
  • Alopecia: hair loss.
  • Fatigue and weakness.
  • Abdominal cramping.

Serious or Rare Side Effects

  • Febrile neutropenia: infection with fever.
  • Severe colitis or intestinal perforation.
  • Anaphylactic or severe allergic reactions.
  • Hepatotoxicity: elevated liver enzymes.
  • Severe electrolyte disturbances.
  • Rare cases of pulmonary toxicity.

Precautions & Warnings

  • Prior to initiating therapy, several safety considerations should be observed.
  • Monitor blood counts: perform regular complete blood counts to detect neutropenia.
  • Assess liver function: obtain baseline and periodic liver enzyme tests.
  • Maintain hydration: ensure adequate fluid intake to mitigate diarrhoea risk.
  • Avoid strong CYP3A4 inhibitors: concurrent use may increase irinotecan exposure.
  • Pregnancy safety: unknown; avoid use in pregnant women unless benefits outweigh risks.
  • 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 toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): may increase systemic exposure and toxicity.
  • Concurrent myelosuppressive agents: heightened risk of severe bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Carboplatin or other platinum compounds: additive myelosuppression.
  • Warfarin: potential increase in bleeding risk.
  • UGT1A1 inhibitors (e.g., atazanavir): may raise SN‑38 levels and toxicity.

Frequently Asked Questions

Irinotecan Viatris is an intravenous chemotherapy agent indicated for the treatment of colorectal cancer, metastatic colorectal cancer and other solid tumours. It is typically used as part of combination regimens to inhibit tumour growth.

The drug is converted inside cells to the active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately cancer cell death.

The specific dose and schedule are determined by the prescribing oncologist based on the patient’s condition, body surface area, and treatment protocol. Dosing is individualized and should follow the prescriber’s instructions.

Safety data in pregnancy and lactation are limited. The product should be avoided in pregnant or nursing women unless the potential benefit justifies the potential risk to the fetus or infant, and only under close medical supervision.

Enquiries are submitted via the product page on gnhindia.com, where you specify the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and import documentation.

Irinotecan is a pro‑drug converted to SN‑38, whereas other agents such as topotecan are administered directly. Both share a similar mechanism of stabilising the topoisomerase I‑DNA complex, but differences in pharmacokinetics, toxicity profiles and approved indications may influence the choice of therapy.

The injectable solution should be stored at 2‑8 °C, protected from light, and must not be frozen or shaken. Before administration, inspect the vial for particulate matter and ensure the solution is at room temperature if required by the clinical protocol.

Irinotecan Viatris is given as an intravenous infusion, usually over 30 to 90 minutes depending on the regimen. Administration is performed by qualified healthcare professionals in a clinical setting, with appropriate monitoring for infusion‑related reactions.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhoea or colitis, hepatic toxicity, and rare allergic reactions. Prompt recognition and supportive care are essential to manage these complications.

Patients with known hypersensitivity to irinotecan or any of its excipients, those with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment should not receive the drug. Use is also contraindicated in pregnant women unless absolutely necessary.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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