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 intravenous solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer in adult patients, acting to disrupt tumor DNA replication and may be used as part of combination chemotherapy regimens under specialist oncology supervision.

GNH India supplies Iritec as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide and clinical research institutions with reliable logistics and regulatory support ensuring timely delivery.

Manufacturer / TM Owner

Vianex S.A.

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Indications & Clinical Uses

Iritec (irinotecan) is used in oncologic regimens targeting cancers that rely on rapid DNA synthesis.

  • Metastatic colorectal cancer: improves progression‑free survival when combined with fluoropyrimidine‑based chemotherapy.
  • Small cell lung cancer: contributes to tumor response as part of combination protocols.
  • Adjuvant colorectal cancer: used after surgery to reduce risk of disease recurrence.

How It Works

  • Irinotecan Hydrochloride Trihydrate is a prodrug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilizing the DNA‑topoisomerase I complex, it prevents relegation of single‑strand breaks during DNA replication, leading to accumulation of DNA damage and ultimately tumor cell death.

Side Effects

Iritec may cause a range of adverse reactions, which are categorized by frequency and severity.

Common Side Effects

  • Diarrhea: may be severe and require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea: often managed with antiemetics.
  • Fatigue: general tiredness affecting daily activities.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils, a medical emergency.
  • Severe colitis: intense intestinal inflammation leading to dehydration.
  • Allergic reaction: includes rash, itching, and possible anaphylaxis.

Precautions & Warnings

Prior to initiating therapy, clinicians should evaluate patient‑specific factors and monitor for toxicity.

  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess liver function: adjust dosing in hepatic impairment.
  • Evaluate bowel status: avoid use in patients with recent obstruction.
  • Use prophylactic antiemetics: to reduce nausea and vomiting.
  • Adjust dose for renal dysfunction: consider reduced exposure.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Iritec can interact with several medicines that affect its metabolism or increase toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole): increase irinotecan exposure.
  • UGT1A1 inhibitors (e.g., atazanavir): raise risk of severe neutropenia.
  • Concurrent topoisomerase I inhibitors: additive toxicity.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin): may reduce efficacy.
  • Other myelosuppressive agents: enhance bone‑marrow suppression.
  • Drugs affecting electrolyte balance (e.g., diuretics): may worsen diarrhea.

Frequently Asked Questions

Iritec contains irinotecan, a chemotherapy agent indicated for the treatment of metastatic colorectal cancer and, in combination regimens, for small cell lung cancer and adjuvant colorectal cancer. It works by interfering with tumor DNA replication, helping to control disease progression.

Irinotecan is a pro‑drug that is converted inside cancer cells to SN‑38, an active metabolite that inhibits topoisomerase I. This enzyme normally relaxes DNA during replication; its inhibition creates DNA strand breaks that cannot be repaired, leading to tumor cell death.

The specific dose of Iritec is determined by the prescribing oncologist based on the patient’s weight, disease stage, and treatment protocol. Typical regimens involve an intravenous infusion given every two weeks, but exact dosing and schedule are individualized and must follow the prescriber’s orders.

Safety of Iritec during pregnancy and lactation has not been established. It is generally contraindicated because of potential harm to the fetus or nursing infant. Women of child‑bearing potential should use effective contraception and discuss risks with their healthcare provider.

To order Iritec, submit an enquiry on the 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 if needed) and import documentation.

Iritec belongs to the topoisomerase I inhibitor class, similar to topotecan. Compared with topotecan, irinotecan has a longer half‑life and is often used in colorectal cancer regimens, whereas topotecan is more common in ovarian and small‑cell lung cancer. Choice depends on tumor type, prior therapy and physician judgment.

Iritec must be stored at 2‑8 °C in a refrigerator. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking. Before administration, allow the solution to reach room temperature if required and inspect for particulate matter.

Iritec is administered by intravenous infusion. The prepared solution is infused over a prescribed period, usually 30 to 90 minutes, under the supervision of qualified medical staff. Infusion rates and pre‑medication (e.g., anti‑emetics) are determined by the treating oncologist.

The most serious adverse events include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, and hypersensitivity reactions that can progress to anaphylaxis. Prompt medical attention is required if patients develop high fever, persistent diarrhea, or signs of an allergic reaction.

Iritec should be avoided in patients with known hypersensitivity to irinotecan or any formulation component, those with severe bone‑marrow suppression, uncontrolled infections, or recent bowel obstruction. Caution is also advised for individuals with significant hepatic impairment or who are pregnant.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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