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

Irinotesin

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotesin (Irinotecan Hydrochloride Trihydrate)

Irinotecan, the active ingredient in Irinotesin, is a topoisomerase I inhibitor presented as an injectable solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer, primarily in adult patients whose disease has progressed after standard therapies. The drug is administered under the supervision of oncology specialists and requires careful monitoring of blood counts and organ function.

GNH India supplies Irinotesin as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance.

Manufacturer / TM Owner

Teva B.V

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Indications & Clinical Uses

  • Irinotecan is a topoisomerase I inhibitor used in the management of colorectal cancer.
  • Metastatic colorectal cancer: improves survival in patients with advanced disease.
  • Adjuvant colon cancer: reduces risk of recurrence after surgical resection.
  • Colorectal cancer combination therapy: used with fluorouracil and leucovorin to enhance treatment efficacy.

How It Works

  • Irinotecan is converted intracellularly to its active metabolite SN‑38, which binds to the DNA-topoisomerase I complex and stabilizes it, preventing the re‑ligation step of DNA replication. This inhibition leads to accumulation of DNA breaks, ultimately triggering apoptosis in rapidly dividing tumor cells while sparing most normal tissues.

Side Effects

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

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Nausea and vomiting: may be managed with antiemetics.
  • Fatigue: commonly reported during treatment cycles.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: hair loss may occur during therapy.
  • Anemia: decreased red blood cell levels causing fatigue.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe colitis: intense inflammation of the colon that can be life‑threatening.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Hypersensitivity reactions: including rash, bronchospasm, or anaphylaxis.
  • Cardiotoxicity: rare cardiac events such as arrhythmias.
  • Secondary malignancies: very rare risk of developing new cancers.

Precautions & Warnings

  • Before initiating Irinotecan therapy, clinicians should assess patient suitability and monitor for potential complications.
  • Monitor blood counts: perform regular CBC to detect neutropenia.
  • Assess liver function: check hepatic enzymes prior to each cycle.
  • Maintain hydration: ensure adequate fluid intake to reduce risk of severe diarrhea.
  • Avoid strong CYP3A4 inhibitors: drugs like ketoconazole can increase toxicity.
  • Pregnancy and lactation: use only if potential benefit justifies potential risk.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole): may increase SN‑38 exposure.
  • Concurrent myelosuppressive agents: can exacerbate neutropenia and anemia.
  • High‑dose warfarin: may enhance anticoagulant effect and bleeding risk.

Moderate Interactions (Monitor Closely)

  • CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce drug effectiveness.
  • Antidiarrheal agents (e.g., loperamide): may mask early signs of severe diarrhea.
  • Anticoagulants (e.g., heparin): monitor coagulation parameters.

Frequently Asked Questions

Irinotesin contains the active ingredient irinotecan, which is used primarily to treat metastatic colorectal cancer. It may be employed as a single agent or in combination with other chemotherapy drugs to improve survival and disease control in patients with advanced-stage disease.

Irinotecan is converted inside cells to the metabolite SN‑38, which binds to the DNA‑topoisomerase I complex and prevents the re‑ligation of DNA strands during replication. This leads to accumulation of DNA breaks, triggering apoptosis of rapidly dividing cancer cells while sparing most normal tissues.

The dosing regimen for Irinotesin is determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Dosage adjustments may be required for renal or hepatic impairment, and the prescriber will set the appropriate schedule.

Irinotecan is classified as a pregnancy‑category unknown drug. It should only be used during pregnancy or lactation if the potential benefit justifies the potential risk to the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment and for a defined period afterward.

To request Irinotesin, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide. After submission, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain if needed) and any required import documentation.

Irinotecan is a widely used topoisomerase I inhibitor with a well‑characterized efficacy profile in colorectal cancer. Compared with other agents in the same class, such as topotecan, irinotecan has a distinct toxicity spectrum, notably a higher incidence of severe diarrhea, while topotecan is more associated with hematologic toxicity. Choice of therapy depends on tumor type, prior treatment, and patient tolerance.

Irinotesin should be stored at 2‑8 °C (refrigerated). Keep the product in its original packaging, protect it from light, and do not freeze or shake the vial. Once prepared for infusion, use the solution within the time frame specified by the manufacturer and follow aseptic techniques.

Irinotesin is supplied as an injectable solution for intravenous infusion. It is administered by a qualified healthcare professional, typically over a period of 30 to 90 minutes, depending on the prescribed protocol. Infusion rates and pre‑medication (e.g., anti‑emetics) are determined by the treating physician.

The most serious risks of Irinotesin include severe neutropenia leading to infection, febrile neutropenia, life‑threatening diarrhea or colitis, hepatic toxicity, and rare hypersensitivity reactions such as anaphylaxis. Patients should be monitored closely for signs of infection, gastrointestinal distress, and liver function abnormalities throughout treatment.

Irinotesin is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients. It should be used with caution in individuals with significant bone‑marrow suppression, severe hepatic impairment, or uncontrolled infections. Pregnant or breastfeeding women should only use the drug when the potential benefits outweigh the risks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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