GNH USA

Europe — EMA

Irinotecan Amarox

GNH USA supplies Irinotecan Amarox (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer.

Irinotecan Hydrochloride Trihydrate

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What is 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 USA 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.

What is Irinotecan Hydrochloride Trihydrate used for?

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.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

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)

What precautions apply to Irinotecan Hydrochloride Trihydrate?

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.

What does Irinotecan Hydrochloride Trihydrate interact with?

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

What is Irinotecan Amarox used for?+
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.
How does Irinotecan work?+
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.
What is the usual dose of Irinotecan Amarox?+
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.
Is Irinotecan safe during pregnancy or breastfeeding?+
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.
How do I order Irinotecan Amarox from GNH USA?+
To request Irinotecan Amarox, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Irinotecan compare with other colorectal cancer drugs?+
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.
How should Irinotecan Amarox be stored and handled?+
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.
How is Irinotecan administered?+
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.
What are the most serious risks associated with Irinotecan?+
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.
Who should not use Irinotecan Amarox?+
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.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Irinotecan Hydrochloride Trihydrate
Route
Intravenous Use
Manufacturer
Amarox Pharma Gmbh
Origin
EU

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