GNH USA

Europe — EMA

Irinotecan Aurobindo

GNH USA supplies Irinotecan Aurobindo (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer. Request a quote for worldwide supply.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan, 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, targeting tumor cells that rely on topoisomerase I activity for DNA replication.

GNH USA supplies Irinotecan Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory documentation to support import and clinical use across multiple regions.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is employed in the management of colorectal cancer, specifically targeting metastatic disease by interfering with DNA replication in rapidly dividing tumor cells.

Metastatic colorectal cancer: when used in combination with fluoropyrimidine‑based regimens, it contributes to tumor shrinkage, prolongs progression‑free survival, and can improve overall survival in patients with advanced disease. Second‑line metastatic colorectal cancer after oxaliplatin‑based therapy: provides an alternative mechanism of action, offering disease control for patients whose tumors progressed on prior regimens. Combination with targeted agents (e.g., bevacizumab) in metastatic colorectal cancer: enhances therapeutic efficacy by adding cytotoxic activity to anti‑angiogenic treatment.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause a range of adverse reactions, varying in frequency and severity.

Common Side Effects: - Diarrhea: often severe and may require antidiarrheal treatment. - Nausea and vomiting: typical chemotherapy‑related symptoms. - Neutropenia: reduced white blood cell count increasing infection risk. - Alopecia: hair loss during treatment.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophils requiring urgent medical care. - Severe colitis (including ileitis): inflammation of the colon that can be life‑threatening. - Hypersensitivity reactions: rash, flushing, or anaphylaxis.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

When using Irinotecan, careful monitoring and patient counseling are essential to mitigate risks. - Dose adjustment: required for patients with hepatic impairment due to altered metabolism. - Monitoring: regular blood counts and liver function tests are essential during therapy. - Drug interactions: avoid concomitant use with strong CYP3A4 inhibitors that may increase SN‑38 exposure. - Pregnancy and lactation: use only if potential benefit justifies risk; limited data available. - Patient education: advise prompt reporting of severe diarrhea or fever. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Irinotecan Hydrochloride Trihydrate interact with?

Irinotecan interacts with several drug classes; awareness helps prevent toxicity.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): may markedly increase SN‑38 levels and toxicity. - UGT1A1 inhibitors (e.g., atazanavir): can reduce SN‑38 clearance, raising risk of neutropenia.

Moderate Interactions (Monitor Closely): - Anticoagulants (e.g., warfarin): increased bleeding risk due to mucosal damage. - Other myelosuppressive agents (e.g., carboplatin): additive bone marrow suppression. - Neurotoxic drugs (e.g., vincristine): potential enhanced neurotoxicity.

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 to help shrink tumors, delay disease progression, and improve overall survival in patients with advanced disease.
How does Irinotecan work?+
Irinotecan is a prodrug that is converted inside cells to the active metabolite SN‑38. SN‑38 inhibits DNA topoisomerase I, preventing the re‑ligation of single‑strand DNA breaks. This leads to accumulation of DNA damage, halting replication and ultimately causing apoptotic death of rapidly dividing cancer cells.
What determines the dose of Irinotecan Aurobindo?+
The dose of Irinotecan Aurobindo is individualized by the prescribing oncologist based on factors such as the patient’s body surface area, liver function, prior treatment history, and overall clinical condition. No fixed regimen is provided here; the prescriber sets the appropriate dosing schedule.
Is Irinotecan safe in pregnancy or breastfeeding?+
Irinotecan is classified as a high‑risk medication for use during pregnancy and lactation. It should only be used if the potential benefit to the mother outweighs the possible risk to the fetus or infant, and it is generally avoided unless no safer alternatives exist.
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 supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials before providing pricing, availability, shipping details and import documentation.
How does Irinotecan compare with other colorectal cancer chemotherapies?+
Irinotecan belongs to the topoisomerase I inhibitor class, offering a distinct mechanism from oxaliplatin‑based regimens. When combined with fluoropyrimidines, it provides an alternative line of therapy, especially after progression on oxaliplatin. Its efficacy and toxicity profile differ, with notable risks of severe diarrhea and neutropenia that require specific management.
What are the recommended storage and handling conditions for Irinotecan Aurobindo?+
Irinotecan Aurobindo should be stored at 2‑8 °C in a refrigerator, protected from light. The product must not be frozen or shaken. Keep the vial in its original packaging until use to maintain stability and ensure sterility.
How is Irinotecan administered to patients?+
Irinotecan Aurobindo is supplied as an injectable solution for intravenous infusion. It is reconstituted according to the manufacturer’s instructions and administered by a qualified healthcare professional, usually over a period of 30‑90 minutes, depending on the specific treatment protocol.
What are the most serious risks to watch for during Irinotecan therapy?+
The most serious adverse events include severe (grade 3‑4) neutropenia, febrile neutropenia, and life‑threatening diarrhea or colitis. Prompt medical attention is required if patients develop high fever, persistent vomiting, or severe abdominal pain, as these may indicate potentially fatal complications.
Who should not receive Irinotecan Aurobindo?+
Patients with known hypersensitivity to Irinotecan or any of its excipients, those with severe hepatic impairment, or individuals with uncontrolled infections should not receive the drug. Additionally, it is contraindicated in patients for whom the risk of severe toxicity outweighs any potential therapeutic benefit.
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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