Europe — EMA
Irinotecan Mylan (Irinotecan Hydrochloride Trihydrate)
GNH USA supplies Irinotecan Mylan (Irinotecan), a topoisomerase I inhibitor for metastatic colorectal cancer and solid tumors. Request a quote for supply.
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What is Irinotecan Hydrochloride Trihydrate?
Irinotecan Hydrochloride Trihydrate, the active ingredient in Irinotecan Mylan, is a topoisomerase I inhibitor presented as an intravenous solution for intravenous use. It treats metastatic colorectal cancer and advanced solid tumors in adult patients.
GNH USA supplies Irinotecan Mylan as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide.
What is Irinotecan Hydrochloride Trihydrate used for?
Irinotecan Mylan is a topoisomerase I inhibitor used in oncology for several cancer types.
- Metastatic colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based regimens. - Advanced solid tumors: provides antitumor activity in a range of refractory solid malignancies. - Colorectal cancer (adjuvant setting): used as part of combination therapy to reduce recurrence risk after surgical resection.
What are the side effects of Irinotecan Hydrochloride Trihydrate?
Irinotecan may cause a range of adverse reactions, from mild to severe.
Common Side Effects: - Nausea and vomiting: gastrointestinal upset common during infusion. - Diarrhea: may be severe and require antidiarrheal therapy. - Neutropenia: reduced white blood cell count increasing infection risk. - Alopecia: temporary hair loss during treatment. - Fatigue: general tiredness and weakness. - Anemia: decreased red blood cell levels causing fatigue.
Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophils requiring urgent care. - Severe colitis: inflammation of the colon that can be life‑threatening. - Hepatotoxicity: liver enzyme elevations indicating liver injury. - Hypersensitivity reactions: rash, bronchospasm, or anaphylaxis during infusion. - Cardiac toxicity: rare arrhythmias or ischemic events. - Secondary malignancies: very rare risk of new cancers after prolonged exposure.
What precautions apply to Irinotecan Hydrochloride Trihydrate?
Before initiating therapy, clinicians should assess patient health status and monitor for specific risks.
- Baseline blood counts: obtain CBC to detect pre‑existing neutropenia or anemia. - Liver function: evaluate hepatic enzymes as irinotecan metabolism is hepatic. - Renal function: adjust monitoring if creatinine clearance is impaired. - Concomitant medications: review for drugs that may increase toxicity, especially CYP3A4 inhibitors. - Pregnancy and lactation: avoid use unless benefits clearly outweigh potential fetal or infant risks. - Store at ambient temperature: keep in original container, protect from light and moisture, and do not freeze.
What does Irinotecan Hydrochloride Trihydrate interact with?
Irinotecan can interact with several drug classes, altering efficacy or toxicity.
Major Interactions (Avoid): - Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase SN‑38 exposure and toxicity. - CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce therapeutic effect. - Anticholinergic agents: can exacerbate irinotecan‑induced diarrhea.
Moderate Interactions (Monitor Closely): - Warfarin: may enhance anticoagulant effect, requiring INR monitoring. - UGT1A1 inhibitors (e.g., atazanavir): can raise SN‑38 levels, increasing risk of neutropenia. - Other myelosuppressive chemotherapy: may compound bone‑marrow suppression, necessitating frequent blood count checks.



