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

Iritec

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Iritec (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Iritec, is a topoisomerase I inhibitor presented as an injectable solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer in adult patients.

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

Manufacturer / TM Owner

Vianex S.A.

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Indications & Clinical Uses

Iritec is a chemotherapy agent that targets the topoisomerase I pathway in solid tumours, primarily colorectal cancer.

  • Metastatic colorectal cancer: improves overall survival when used in standard regimens.
  • Advanced colorectal cancer: provides disease control in patients who have progressed on prior therapy.
  • Combination therapy for colorectal cancer: enhances the efficacy of fluoropyrimidine‑based regimens.

How It Works

  • Irinotecan is a pro‑drug that is converted in vivo to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the enzyme‑DNA cleavable complex, it prevents relegation of single‑strand DNA breaks, leading to accumulation of DNA damage, inhibition of replication and transcription, and ultimately cancer cell death.

Side Effects

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

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: generalized tiredness.
  • Anemia: decreased red blood cell count.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent treatment.
  • Severe colitis or intestinal perforation.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Hepatotoxicity: elevated liver enzymes or liver failure.
  • Pulmonary toxicity: interstitial pneumonitis.
  • Hemorrhagic cystitis: bladder inflammation with bleeding.

Precautions & Warnings

Before initiating Iritec, clinicians should consider several safety measures.

  • Baseline blood counts: assess neutrophil and platelet levels.
  • Liver function monitoring: evaluate transaminases and bilirubin.
  • Renal function assessment: check creatinine clearance.
  • Pregnancy and lactation: avoid use unless benefits outweigh risks.
  • Concomitant infections: treat active infections before chemotherapy.
  • Storage: Store at 2‑8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Iritec can interact with other medicines, altering its efficacy or toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase SN‑38 exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia.
  • Live vaccines: may cause uncontrolled infection.

Moderate Interactions (Monitor Closely)

  • Other myelosuppressive agents: cumulative bone‑marrow suppression.
  • Anticoagulants (warfarin, DOACs): heightened bleeding risk.
  • Antidiarrheal agents (loperamide): may mask early signs of severe diarrhea.
  • Proton pump inhibitors: possible alteration of gastric pH affecting absorption of oral supportive drugs.

Frequently Asked Questions

Iritec contains irinotecan and is used as a chemotherapy agent for the treatment of metastatic and advanced colorectal cancer, often in combination with other anticancer drugs to improve disease control.

Irinotecan is converted in the body to SN‑38, which inhibits topoisomerase I. This prevents DNA strand re‑ligation during replication, causing DNA breaks, halting tumor cell replication and leading to cell death.

The dose of Iritec is individualized by the prescribing oncologist based on the patient’s weight, disease stage, and treatment protocol. Exact dosing regimens are determined by the treating physician.

Iritec is classified as contraindicated in pregnancy and breastfeeding unless the potential benefit justifies the risk. It may cause fetal harm, and nursing mothers should avoid breastfeeding while receiving the drug.

To order Iritec, submit an enquiry on the product page at gnhindia.com with 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 needed) and import documentation.

Iritec (irinotecan) belongs to the topoisomerase I inhibitor class, differing from fluoropyrimidines (e.g., 5‑FU) and oxaliplatin which target DNA synthesis and cross‑linking. Irinotecan is often combined with 5‑FU/leucovorin to enhance response rates, offering an alternative mechanism of action and a distinct side‑effect profile.

Iritec should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen. Keep the vial in its original packaging until ready for preparation and administration.

Iritec is supplied as an injectable solution for intravenous infusion. It is administered by a qualified healthcare professional, typically over 30–90 minutes, according to the prescribing oncologist’s protocol.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hypersensitivity reactions, and hepatic or pulmonary toxicity. Prompt monitoring and supportive care are essential.

Iritec should not be used in patients with known hypersensitivity to irinotecan or its excipients, in those with uncontrolled infections, or in pregnant women unless the benefit outweighs the risk. Caution is advised for patients with significant liver or kidney impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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