GNH USA

Europe — EMA

Irinotecán Aurovitas

GNH USA supplies Irinotecán Aurovitas (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer and other solid tumours.

Irinotecan Hydrochloride Trihydrate

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What is Irinotecan Hydrochloride Trihydrate?

Irinotecan, the active ingredient in Irinotecán Aurovitas, is a topoisomerase I inhibitor presented as an injection solution for intravenous use. It is employed in the treatment of metastatic colorectal cancer and other solid tumours in adult oncology patients.

GNH USA supplies Irinotecán Aurovitas as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, with sourcing from the European Union market. The product conforms to EU quality standards and is manufactured under GMP conditions.

What is Irinotecan Hydrochloride Trihydrate used for?

Irinotecan is used in oncology to target DNA replication in rapidly dividing cancer cells.

- Metastatic colorectal cancer: improves overall survival and disease control when combined with fluoropyrimidine therapy. - Other solid tumours: incorporated into combination regimens to reduce tumor burden in selected patients. - Colorectal cancer (adjuvant setting): may be administered as part of postoperative chemotherapy to lower recurrence risk.

What are the side effects of Irinotecan Hydrochloride Trihydrate?

Irinotecan may cause a range of adverse reactions, from mild to life‑threatening.

Common Side Effects: - Diarrhea: often severe and may require antidiarrheal therapy. - Nausea and vomiting: managed with antiemetics. - Fatigue: common during treatment cycles. - Neutropenia: reduced white blood cell count increasing infection risk. - Alopecia: hair loss may occur. - Abdominal pain: can accompany gastrointestinal toxicity.

Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count requiring urgent care. - Severe colitis or intestinal perforation. - Hepatotoxicity: marked elevation of liver enzymes. - Allergic reactions: rash, bronchospasm, or anaphylaxis. - Cardiac toxicity: rare arrhythmias or myocardial ischemia. - Secondary malignancies: very rare long‑term risk.

What precautions apply to Irinotecan Hydrochloride Trihydrate?

Prior to initiating Irinotecan therapy, several safety considerations are recommended.

- Monitor blood counts: perform regular CBC to detect neutropenia. - Assess liver function: adjust dose in hepatic impairment. - Evaluate renal function: consider dose modification in severe renal failure. - Avoid in patients with bowel obstruction: risk of perforation. - Use prophylactic antiemetics: to reduce nausea and vomiting. - Adjust dose for hepatic impairment: follow prescribing information. - 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 that may alter its efficacy or safety.

Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole): increase SN‑38 exposure. - Strong CYP3A4 inducers (e.g., rifampin): decrease efficacy. - Live vaccines: risk of infection due to immunosuppression. - Anticoagulants (e.g., warfarin): heightened bleeding risk. - High‑dose aspirin: may exacerbate gastrointestinal toxicity.

Moderate Interactions (Monitor Closely): - Other myelosuppressive agents (e.g., carboplatin): additive bone‑marrow suppression. - Antidiarrheal agents (e.g., loperamide): may mask severity of diarrhea. - Proton pump inhibitors: potential effect on gastric pH and absorption. - Herbal supplements (e.g., St. John’s wort): possible CYP induction. - Electrolyte‑altering drugs: monitor for electrolyte imbalance during diarrhea.

Frequently asked questions

What is Irinotecán Aurovitas used for?+
Irinotecán Aurovitas contains irinotecan, a chemotherapy agent used primarily for the treatment of metastatic colorectal cancer and selected other solid tumours. It is administered intravenously as part of combination regimens to inhibit tumor growth.
How does irinotecan work in cancer therapy?+
Irinotecan is converted inside cells to the active metabolite SN‑38, which blocks topoisomerase I. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to DNA damage, halted cell division, and ultimately apoptosis of rapidly dividing cancer cells.
What is the usual dose of Irinotecán Aurovitas?+
The specific dose and schedule of Irinotecán Aurovitas are determined by the prescribing oncologist based on the patient’s condition, body surface area, and treatment protocol. No standardized dose is provided here; clinicians set the regimen according to approved guidelines.
Is Irinotecán Aurovitas safe during pregnancy or breastfeeding?+
Irinotecan is classified as contraindicated in pregnancy because it can cause fetal harm. It is also not recommended while breastfeeding, as it may be excreted in milk and affect the infant. Women of child‑bearing potential should use effective contraception during treatment.
How do I order Irinotecán Aurovitas from GNH USA?+
To place an order, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA supplies 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 Irinotecán Aurovitas compare with other topoisomerase I inhibitors?+
Irinotecan is the most widely used topoisomerase I inhibitor in colorectal cancer, offering a well‑characterized efficacy and safety profile. Compared with newer agents, it has extensive clinical data, but may present higher rates of gastrointestinal toxicity, requiring proactive management.
What are the storage and handling requirements for Irinotecán Aurovitas?+
The product should be stored refrigerated at 2‑8 °C, protected from light, and must not be frozen or shaken. Prior to infusion, the solution is allowed to reach room temperature if required by the administration protocol.
How is Irinotecán Aurovitas administered?+
Irinotecán Aurovitas is supplied as an injectable solution for intravenous infusion. It is typically infused over 30‑90 minutes, depending on the prescribed regimen, and is administered by qualified healthcare professionals in a clinical setting.
What are the most serious risks associated with Irinotecán Aurovitas?+
The most serious adverse events include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea or colitis, hepatic toxicity, and rare allergic reactions. Prompt monitoring and supportive care are essential to mitigate these risks.
Who should not receive Irinotecán Aurovitas?+
Patients with known hypersensitivity to irinotecan or its excipients, those with uncontrolled bowel obstruction, severe hepatic impairment, or active infections should not receive Irinotecán Aurovitas. The decision must be made by a qualified oncologist.
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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