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

Irinotecan Sun

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Sun (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Sun, is a Topoisomerase I inhibitor presented as a solution for injection for intravenous use. It is indicated for metastatic colorectal cancer and as adjuvant therapy for colon cancer in adult patients.
GNH India supplies Irinotecan Sun as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.

Manufacturer / TM Owner

Sun Pharmaceutical Industries Europe B.V.

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Indications & Clinical Uses

  • Irinotecan Sun is a Topoisomerase I inhibitor used in colorectal cancer treatment pathways.
  • Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based regimens.
  • Adjuvant therapy for colon cancer: reduces risk of disease recurrence after surgical resection.
  • Locally advanced colorectal cancer: may be employed in neoadjuvant protocols to shrink tumors before surgery.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly to SN‑38, a potent inhibitor of topoisomerase I. By stabilising the enzyme‑DNA complex, it prevents relegation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately tumor cell apoptosis.

Side Effects

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

Common Side Effects

  • Diarrhea: often severe and may require antidiarrheal therapy.
  • Neutropenia: reduced white blood cell count increasing infection risk.
  • Nausea and vomiting: may be managed with antiemetics.
  • Alopecia: temporary hair loss.
  • Fatigue: generalized tiredness during treatment.
  • Abdominal cramping: discomfort in the stomach area.

Serious or Rare Side Effects

  • Febrile neutropenia: fever with low neutrophil count requiring urgent care.
  • Severe colitis: inflammation of the colon that can be life‑threatening.
  • Hepatotoxicity: elevated liver enzymes indicating liver injury.
  • Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis.
  • Hemorrhagic cystitis: bladder inflammation with bleeding.
  • Cardiotoxicity: rare cardiac dysfunction or arrhythmias.

Precautions & Warnings

Before initiating Irinotecan Sun, clinicians should assess patient suitability and monitor for known risks.

  • Baseline blood counts: obtain complete blood count to detect pre‑existing neutropenia.
  • Liver function: evaluate hepatic enzymes as impaired function can increase toxicity.
  • Renal function: adjust monitoring for patients with reduced clearance.
  • Concomitant medications: review for agents that may exacerbate myelosuppression.
  • Pregnancy and lactation: avoid use unless benefits clearly outweigh potential fetal or infant risks.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

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

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine): may reduce SN‑38 exposure.
  • Anticholinergic agents (e.g., atropine, scopolamine): increase risk of severe diarrhea.
  • High‑dose corticosteroids: may potentiate neutropenia.

Moderate Interactions (Monitor Closely)

  • Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin): may raise SN‑38 levels.
  • Warfarin: monitor INR as Irinotecan can affect coagulation.
  • UGT1A1 polymorphisms: genetic testing may be warranted to adjust dosing.

Frequently Asked Questions

Irinotecan Sun is an intravenous chemotherapy solution indicated for the treatment of metastatic colorectal cancer and as adjuvant therapy following surgical resection of colon cancer. It is used in adult patients as part of combination regimens to improve survival outcomes.

Irinotecan is converted inside tumor cells to its active metabolite SN‑38, which inhibits topoisomerase I. This enzyme normally relieves torsional strain during DNA replication; its inhibition prevents DNA strand religation, leading to accumulation of DNA breaks and tumor cell death.

The dosing regimen for Irinotecan Sun is individualized by the prescribing oncologist based on factors such as cancer type, treatment protocol, patient weight, and organ function. Healthcare professionals determine the appropriate dose and schedule for each patient.

The safety of Irinotecan Sun in pregnancy or while breastfeeding has not been established. It is generally contraindicated unless the potential benefit to the mother outweighs the possible risk to the fetus or infant. Consultation with a specialist is essential.

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 if needed), and import documentation.

Irinotecan belongs to the topoisomerase I inhibitor class, differing from agents such as oxaliplatin (a platinum compound) or fluoropyrimidines (e.g., 5‑FU). It is often combined with these drugs to enhance efficacy, offering a distinct mechanism that can overcome resistance to other chemotherapy classes.

Irinotecan Sun should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. The solution should be kept in its original packaging until ready for preparation and administration in a clinical setting.

Irinotecan Sun is administered intravenously by a qualified healthcare professional. The solution is typically infused over a set period, often 30‑90 minutes, depending on the treatment protocol and patient tolerance.

The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatotoxicity, and rare hypersensitivity reactions such as anaphylaxis. Prompt medical attention is required if any of these events occur.

Patients with known hypersensitivity to Irinotecan or any component of the formulation should avoid its use. Additionally, individuals with severe bone‑marrow suppression, uncontrolled infections, or significant hepatic impairment may be contraindicated, pending clinical assessment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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