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

Irinotecan Hydrochloride Trihydrate Sun

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Hydrochloride Trihydrate Sun (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Hydrochloride Trihydrate Sun, is a Topoisomerase I inhibitor presented as a sterile powder for intravenous use. It is used in the treatment of metastatic colorectal cancer and as adjuvant therapy for colon cancer in adult patients.

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

Manufacturer / TM Owner

Sun Pharmaceutical Industries Europe B.V.

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Indications & Clinical Uses

Irinotecan Hydrochloride Trihydrate is employed in colorectal cancer management, targeting tumor growth and spread.

  • Metastatic colorectal cancer: improves survival when combined with fluoropyrimidine chemotherapy.
  • Adjuvant treatment of colon cancer: reduces risk of disease recurrence after surgical resection.
  • Advanced colorectal adenocarcinoma: provides tumor control in patients unsuitable for surgery.

How It Works

  • Irinotecan Hydrochloride Trihydrate is a pro‑drug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilizing the topoisomerase‑DNA cleavable complex, it prevents relegation of single‑strand DNA breaks, leading to accumulation of DNA damage, replication arrest, and ultimately apoptotic cell death in rapidly dividing tumor cells.

Side Effects

Irinotecan Hydrochloride Trihydrate may cause a range of adverse reactions, some of which are expected with cytotoxic chemotherapy.

Common Side Effects

  • Nausea and vomiting: may require anti‑emetic therapy.
  • Diarrhea: can be severe and may need antidiarrheal agents.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Alopecia: temporary hair loss.
  • Fatigue: generalized tiredness.
  • Mild hepatic enzyme elevation.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophils, requiring urgent care.
  • Severe colitis or ileitis: potentially life‑threatening bowel inflammation.
  • Hepatic toxicity: marked liver enzyme rise or jaundice.
  • Anaphylactic reactions: rare but may be severe.
  • Severe hypotension: sudden drop in blood pressure during infusion.
  • Secondary malignancies: rare long‑term risk associated with alkylating agents.

Precautions & Warnings

Before 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.
  • Avoid in pregnancy: contraindicated due to fetal risk (Category D).
  • Use anti‑emetics: manage nausea and vomiting proactively.
  • Maintain hydration: ensure adequate fluid intake to reduce diarrhoea severity.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze.

Avoid Interactions

Irinotecan Hydrochloride Trihydrate can interact with several drug classes, influencing efficacy or safety.

Major Interactions (Avoid)

  • Strong CYP3A4 inhibitors: increase irinotecan exposure and toxicity.
  • UGT1A1 inhibitors (e.g., atazanavir): raise SN‑38 levels, heightening risk of neutropenia.
  • Concurrent myelosuppressive agents: additive bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): may enhance bleeding risk.
  • Live vaccines: immunosuppression can reduce vaccine efficacy.
  • Diuretics: potential electrolyte disturbances during fluid loss.
  • Proton‑pump inhibitors: may affect gastric pH but limited impact on IV administration.

Frequently Asked Questions

Irinotecan Hydrochloride Trihydrate is an intravenous chemotherapy agent indicated for the treatment of metastatic colorectal cancer and as an adjuvant therapy after surgical resection of colon cancer. It works by targeting rapidly dividing tumor cells and is typically administered by oncology specialists in a hospital or clinic setting.

The drug is a pro‑drug that is metabolised inside cancer cells to SN‑38, an active metabolite that inhibits topoisomerase I. This enzyme is essential for DNA unwinding during replication. By preventing DNA religation, Irinotecan causes irreversible DNA damage, leading to cell cycle arrest and apoptosis of malignant cells.

The specific dose and schedule are determined by the prescribing oncologist based on the patient’s clinical condition, body surface area, and treatment protocol. Dosing is individualized and may be adjusted for factors such as liver function, prior therapy, and tolerance.

Irinotecan is classified as Pregnancy Category D, indicating evidence of fetal risk. It should not be used during pregnancy unless the potential benefit justifies the risk. Breastfeeding is also contraindicated because the drug can be excreted in milk and may harm the infant.

To place an order, 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 logistics if needed), and required import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, offering a different mechanism from fluoropyrimidines (e.g., 5‑FU) and oxaliplatin. It is often combined with these agents to enhance response rates. Compared with other agents, Irinotecan provides a distinct toxicity profile, notably higher rates of diarrhoea and neutropenia, which require specific monitoring.

The product should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to administration, the sterile powder is reconstituted according to the manufacturer’s instructions in a controlled environment to maintain sterility.

Irinotecan is given as an intravenous infusion, usually over 30 to 90 minutes depending on the protocol. The infusion is performed by trained healthcare professionals in a setting equipped to manage potential infusion reactions and monitor vital signs throughout the administration.

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

Patients with known hypersensitivity to Irinotecan or any of its excipients, those with severe hepatic impairment, and pregnant women should not receive the drug. Additionally, individuals with uncontrolled infections or significant bone‑marrow suppression should be evaluated carefully before treatment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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