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

Irinotecan Amarox

Active Ingredient:
Irinotecan Hydrochloride Trihydrate
Origin:
EU

Irinotecan Amarox (Irinotecan Hydrochloride Trihydrate)

Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Amarox, 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. It belongs to the antineoplastic therapeutic class and is marketed in the European Union.

GNH India supplies Irinotecan Amarox as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide. The product complies with European Union regulatory standards and is distributed under strict quality‑assured conditions.

Manufacturer / TM Owner

Amarox Pharma Gmbh

1
Pack/s
This product is added to your enquiry list

Request a Quote

Please fill out the form below and our team will get back to you shortly with pricing and further information.

A minimum order value applies. Our team will confirm the exact amount or quantity after reviewing your requirements.

Indications & Clinical Uses

Irinotecan Amarox is indicated for colorectal cancer indications where topoisomerase I inhibition is part of the therapeutic strategy.

  • Metastatic colorectal cancer: improves overall survival and disease control in adult patients with metastatic disease.
  • Advanced colorectal cancer: used in combination regimens to reduce tumor burden and delay progression.
  • Recurrent colorectal cancer: administered after prior therapy to achieve tumor response and prolong progression‑free interval.

How It Works

  • Irinotecan is a pro‑drug that is converted intracellularly by carboxylesterases to the active metabolite SN‑38. SN‑38 binds to the DNA‑topoisomerase I complex and stabilizes it, preventing the religation step of DNA replication. This inhibition leads to accumulation of single‑strand DNA breaks, ultimately causing apoptosis of rapidly dividing tumor cells. The drug’s activity is further modulated by glucuronidation via UGT1A1, which influences systemic exposure.

Side Effects

Irinotecan therapy is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting
  • Diarrhea
  • Neutropenia
  • Fatigue
  • Alopecia

Serious or Rare Side Effects

  • Febrile neutropenia
  • Severe or febrile diarrhea (colitis)
  • Hepatic toxicity (elevated transaminases)
  • Allergic reactions (rash, anaphylaxis)
  • Pulmonary toxicity (interstitial pneumonitis)

Precautions & Warnings

Prior to initiating Irinotecan Amarox, clinicians should assess several clinical parameters and follow specific safety measures.

  • Baseline blood counts: obtain complete blood count with differential to monitor for neutropenia.
  • Liver function: evaluate hepatic enzymes because impairment can increase SN‑38 exposure.
  • Renal function: assess creatinine clearance as renal excretion contributes to drug clearance.
  • Hypersensitivity: avoid use in patients with known allergy to irinotecan or formulation excipients.
  • Dose adjustments: consider reduced dosing in patients with moderate hepatic impairment.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Irinotecan may interact with other medicines that affect its metabolism or increase overlapping toxicities.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may markedly reduce SN‑38 levels and efficacy.
  • Potent UGT1A1 inhibitors (e.g., atazanavir, indinavir): can raise SN‑38 exposure and heighten toxicity.
  • Concurrent myelosuppressive agents (e.g., high‑dose cyclophosphamide): increase risk of severe neutropenia.

Moderate Interactions (Monitor Closely)

  • Anticholinergic drugs (e.g., atropine): may mask early signs of diarrhea.
  • Antiemetics such as ondansetron: may be required to control nausea but can affect QT interval.
  • Anticoagulants (e.g., warfarin): monitor coagulation parameters as irinotecan can enhance bleeding risk.

Frequently Asked Questions

Irinotecan Amarox contains the active ingredient irinotecan hydrochloride tri­hydrate and is used as part of chemotherapy regimens for adult patients with metastatic or advanced colorectal cancer. It works by targeting tumor cells that rely on topoisomerase I for DNA replication, helping to control disease spread and improve survival outcomes.

Irinotecan is a pro‑drug that is converted inside cells to SN‑38, a potent inhibitor of the enzyme topoisomerase I. By stabilising the DNA‑topoisomerase I complex, SN‑38 prevents the religation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and ultimately causing cancer cell death.

The dosing of Irinotecan Amarox is individualized by the prescribing oncologist. Factors such as body surface area, disease stage, prior therapies, and the patient’s hematologic and hepatic status are taken into account. The prescriber determines the exact amount, schedule, and any necessary dose adjustments.

Safety of Irinotecan in pregnancy and lactation has not been established. Because the drug can cross the placenta and is excreted in breast milk, it is generally avoided unless the potential benefit justifies the potential risk. Patients who are pregnant, planning pregnancy, or breastfeeding should discuss alternatives with their healthcare provider.

To request Irinotecan Amarox, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, oncology centres, pharmacies and procurement teams worldwide. After the enquiry, 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 belongs to the topoisomerase I inhibitor class, whereas other common agents such as oxaliplatin are platinum‑based DNA cross‑linkers. Irinotecan is often combined with fluoropyrimidines and can be effective after failure of oxaliplatin‑based regimens. The choice between agents depends on prior therapy, toxicity profile, and individual patient factors.

Irinotecan Amarox should be stored at 2‑8 °C (refrigerated). Keep the vials in their original packaging, protect them from light, and do not freeze or shake the solution. Before administration, allow the product to reach room temperature if required by the preparation protocol.

Irinotecan Amarox is given by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and duration are determined by the prescribing physician and may be adjusted based on patient tolerance and concurrent medications. It is typically administered in a clinical setting equipped for monitoring adverse reactions.

The most serious risks include severe neutropenia that can lead to infection, febrile neutropenia, and life‑threatening diarrhea or colitis. Hepatic toxicity, allergic reactions such as anaphylaxis, and rare pulmonary complications like interstitial pneumonitis have also been reported. Prompt medical attention is required if any of these events occur.

Irinotecan should be avoided in patients with known hypersensitivity to irinotecan or any of its excipients, in those with severe hepatic impairment, and in individuals with uncontrolled infections. Caution is also advised for patients with a history of severe gastrointestinal disorders or significant bone‑marrow suppression.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

Disclaimer

At GNH India, we aim to provide information that is expert-reviewed, accurate, and reliable. However, all content on this platform is intended for general informational purposes only and does not constitute professional medical advice, diagnosis, or treatment. While efforts are made to maintain accuracy and currency, the information may contain errors, omissions, or may not reflect the latest developments. Always consult a qualified healthcare professional regarding any medical concerns.

All product names, brand names, trademarks and registered trademarks displayed on this website are the property of their respective owners. This website and its operator are not affiliated with, endorsed by, or authorized by any such trade mark owners unless expressly stated. Any reference to product names or trademarks is made solely for descriptive and informational purposes. No commercial relationship, sponsorship, approval, or association with any trademark owner should be inferred. Information provided herein does not constitute promotion, advertising, or an offer for sale of any medicinal product and is intended solely for general informational purposes.

All trademarks and brand names displayed on this website are used strictly in accordance with the provisions of the Trade Marks Act, 1999, specifically Sections 30 and 30(1) governing fair use. Trademark ownership has been accurately attributed under the "Manufacturer/ TM Owner" section in compliance with statutory requirements.

Ordering Process

Simple, Secure, and Seamless

Learn how our streamlined ordering process guarantees fast, compliant, and reliable access to essential medicines worldwide.

Quote request form

01

Submit Quote Request Form

Tell us what medications you need by filling out our simple form and uploading a valid document.

Price estimate review

02

We Review & Send Estimate

Our licensed pharmacists will verify your details and provide you with a detailed cost estimate.

Secure payment

03

Confirm & Make Payment

Discuss any queries, approve the estimate, and complete your payment.

Worldwide delivery

04

Get Delivered

Your medicines, safely packed and delivered to your door or nearest airport — hassle-free.

Quality You Can Trust

Our internationally recognized certifications underscore our commitment to safety, quality, and excellence.