GNH USA

Europe — EMA

Irinotecan Aurobindo

GNH USA supplies Irinotecan Aurobindo (Irinotecan Hydrochloride), 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 Aurobindo, is a Topoisomerase I inhibitor presented as an injectable formulation for intravenous use. It is employed in the treatment of metastatic colorectal cancer, often in combination with other cytotoxic agents, to inhibit tumor cell proliferation. The drug is manufactured under EU GMP standards and distributed for clinical use.

GNH USA supplies Irinotecan Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier, providing the product to oncology centres, hospitals and pharmacies across global markets.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan Aurobindo is a Topoisomerase I inhibitor used in colorectal cancer treatment pathways. - Metastatic colorectal cancer: used in combination regimens to improve overall survival in patients with advanced disease. - First‑line colorectal cancer therapy: administered with fluorouracil and leucovorin as part of the FOLFIRI regimen to treat newly diagnosed metastatic cases. - Second‑line colorectal cancer therapy: employed after progression on oxaliplatin‑based regimens to provide an alternative cytotoxic option.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan therapy is associated with a range of adverse reactions that require monitoring.

Common Side Effects: - Neutropenia: reduced white blood cell count increasing infection risk. - Diarrhea: often severe and may require antidiarrheal treatment. - Nausea and vomiting: typical chemotherapy‑related gastrointestinal upset. - Fatigue: generalized tiredness affecting daily activities. - Alopecia: temporary hair loss during treatment.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count requiring urgent care. - Severe colitis: intense inflammation of the colon that may be life‑threatening. - Hepatic toxicity: elevated liver enzymes or bilirubin indicating liver injury. - Allergic reactions: rash, itching, or anaphylaxis in susceptible individuals. - Infusion‑related reactions: hypotension, dyspnea, or chest discomfort during administration.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Prior to initiating Irinotecan Aurobindo, clinicians should assess patient risk factors and implement monitoring strategies. - Monitor blood counts: perform regular CBC to detect neutropenia and guide dose adjustments. - Assess liver function: check hepatic enzymes before and during therapy to avoid accumulation of SN‑38. - Maintain hydration: ensure adequate fluid intake to mitigate severe diarrhea. - Avoid concurrent myelosuppressive agents: limit additive bone‑marrow suppression when possible. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the product.

What does Irinotecan Hydrochloride Trihydrate interact with?

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

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): increase SN‑38 exposure and toxicity. - Concurrent myelosuppressive chemotherapy: exacerbate bone‑marrow suppression and infection risk.

Moderate Interactions (Monitor Closely): - CYP3A4 inducers (e.g., rifampin): reduce irinotecan effectiveness by lowering plasma levels. - Drugs affecting bilirubin transport (e.g., atazanavir): may raise SN‑38 concentrations and toxicity. - Warfarin: potential alteration of INR, requiring closer coagulation monitoring. - Antacids containing magnesium or aluminum: may affect gastrointestinal absorption of oral formulations, though less relevant for IV use.

Frequently asked questions

What is Irinotecan Aurobindo used for?+
Irinotecan Aurobindo is indicated for the treatment of metastatic colorectal cancer. It is typically administered as part of combination chemotherapy regimens, such as FOLFIRI, to help control tumor growth and improve patient outcomes.
How does Irinotecan Hydrochloride work?+
The drug is converted inside cells to the active metabolite SN‑38, which binds to the DNA‑topoisomerase I complex. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to DNA damage and ultimately causing cancer cell death.
What is the usual dose of Irinotecan Aurobindo?+
The dosing regimen for Irinotecan Aurobindo is determined by the prescribing oncologist based on individual patient factors, disease stage, and the specific chemotherapy protocol. Only a qualified healthcare professional can set the appropriate dose.
Is Irinotecan safe to use during pregnancy or breastfeeding?+
Irinotecan is classified as contraindicated in pregnancy because it can cause fetal harm. It is also not recommended for breastfeeding mothers, as the drug may be excreted in breast milk and affect the infant. Consultation with a specialist is essential.
How do I order Irinotecan Aurobindo from GNH USA?+
To place an order, submit an enquiry on the Irinotecan Aurobindo product page at gnh-usa.com, specifying the required quantity. GNH USA 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.
How does Irinotecan compare with other Topoisomerase I inhibitors?+
Irinotecan and other Topoisomerase I inhibitors, such as topotecan, share a similar mechanism of preventing DNA re‑ligation. Irinotecan is primarily used for colorectal cancer, whereas topotecan is approved for small‑cell lung cancer and ovarian cancer. Differences in pharmacokinetics, toxicity profiles, and approved indications guide the choice of agent.
What are the storage and handling requirements for Irinotecan Aurobindo?+
The product should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. It should be kept in its original packaging to maintain stability until preparation for intravenous infusion.
How is Irinotecan Aurobindo administered?+
Irinotecan Aurobindo is given by intravenous infusion, usually over 30 to 90 minutes depending on the treatment protocol. The infusion is performed by qualified healthcare personnel in a clinical setting, with appropriate monitoring for infusion‑related reactions.
What are the most serious risks associated with Irinotecan therapy?+
The most serious risks include severe neutropenia leading to infection, febrile neutropenia, life‑threatening diarrhea or colitis, hepatic toxicity, and rare allergic or anaphylactic reactions. Prompt medical attention is required if any of these events occur.
Who should not receive Irinotecan Aurobindo?+
Patients with known hypersensitivity to irinotecan or any of its excipients, those with severe bone‑marrow suppression, uncontrolled infections, or significant liver dysfunction should avoid this medication. Additionally, pregnant or nursing women should not be treated with Irinotecan.
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
Eugia Pharma (Malta) Ltd
Origin
EU

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