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



