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

Irinto

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinto (Irinotecan Hydrochloride Trihydrate)

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

GNH India supplies Irinto as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Hikma Farmacêutica (Portugal), S.A.

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Indications & Clinical Uses

  • Irinto (irinotecan) is used in the treatment of colorectal cancer, targeting tumor growth and spread.
  • Metastatic colorectal cancer: improves overall survival when used in combination chemotherapy regimens.
  • Advanced colorectal cancer: reduces tumor burden and may extend progression‑free survival.
  • Colorectal cancer refractory to standard therapy: provides an additional therapeutic option.

How It Works

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

Side Effects

Common Side Effects

  • Diarrhea: may be severe and require supportive care.
  • Nausea and vomiting: often managed with anti‑emetics.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: hair loss during treatment cycles.
  • Fatigue: general tiredness and weakness.
  • Elevated liver enzymes: mild hepatic irritation.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count, a medical emergency.
  • Severe colitis or life‑threatening diarrhea.
  • Hepatic toxicity: significant liver function impairment.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Cardiac toxicity: rare arrhythmias or myocardial injury.
  • Secondary malignancies: very rare long‑term risk.

Precautions & Warnings

  • Patients receiving Irinto require careful monitoring and individualized care.
  • Dose adjustment: required for patients with hepatic impairment.
  • Monitoring: regular complete blood counts to detect neutropenia.
  • Hydration: ensure adequate fluids to mitigate diarrhea.
  • Drug interactions: avoid concurrent strong CYP3A4 inhibitors.
  • Pregnancy: contraindicated or use only if benefits outweigh risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with several medicines, necessitating vigilance.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase toxicity.
  • Live vaccines: heightened infection risk due to immunosuppression.
  • Concurrent high‑dose radiation therapy: amplified severe diarrhea.
  • Other topoisomerase I inhibitors: additive toxicity.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inducers (e.g., rifampin): may reduce efficacy.
  • Anticoagulants (e.g., warfarin): monitor INR for bleeding.
  • Nephrotoxic agents (e.g., cisplatin): watch renal function.
  • Antidiarrheal agents (e.g., loperamide) at high doses: risk of ileus.
  • Herbal supplements (e.g., St. John’s wort): possible reduced exposure.

Frequently Asked Questions

Irinto contains irinotecan, which is indicated for the treatment of metastatic and advanced colorectal cancer. It is typically administered as part of combination chemotherapy regimens to improve survival and control tumor growth.

Irinotecan is converted inside cells to the active metabolite SN‑38, which inhibits topoisomerase I. This prevents the re‑ligation of single‑strand DNA breaks, leading to accumulation of DNA damage, halted replication, and cancer cell death.

The dose of Irinto is individualized by the prescribing oncologist based on factors such as body surface area, liver function, and treatment protocol. Specific dosing regimens are determined by the treating physician and are not publicly standardized.

Safety of Irinto in pregnancy and lactation has not been established. It is generally avoided during pregnancy unless the potential benefit justifies the risk, and breastfeeding is not recommended while receiving treatment.

Submit an enquiry on the Irinto product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where needed) and import documentation.

The primary alternative is topotecan, another topoisomerase I inhibitor. Irinotecan (Irinto) is most commonly used for colorectal cancer and has a distinct metabolic pathway, while topotecan is primarily employed in ovarian and small‑cell lung cancers, offering different efficacy and toxicity profiles.

Irinto should be stored at 2‑8 °C, protected from light, and kept in its original container. It must not be frozen or shaken, as these conditions can compromise the stability of the intravenous solution.

Irinto is supplied as an intravenous solution and must be administered by a qualified healthcare professional through a controlled IV infusion. The infusion duration typically ranges from 30 to 90 minutes, depending on the specific treatment protocol.

The most serious risks include severe neutropenia, febrile neutropenia, life‑threatening diarrhea or colitis, and hypersensitivity reactions such as rash or anaphylaxis. Prompt monitoring and supportive care are essential to manage these potential complications.

Irinto should not be used by patients with known hypersensitivity to irinotecan or its excipients, those with severe hepatic impairment, and individuals for whom the risk outweighs the benefit, such as certain pregnant women. Clinical judgment is required to determine suitability.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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