Europe — EMA
Mizantrone (Irinotecan Hydrochloride Trihydrate)
GNH USA supplies Mizantrone (Irinotecan), a topoisomerase I inhibitor indicated for the treatment of colorectal cancer and metastatic colorectal cancer.
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What is Irinotecan Hydrochloride Trihydrate?
Irinotecan Hydrochloride Trihydrate, the active ingredient in Mizantrone, is a topoisomerase I inhibitor presented as a sterile powder for reconstitution for intravenous injection. It is indicated for the treatment of colorectal cancer, including metastatic disease, in adult patients undergoing chemotherapy.
GNH USA supplies Mizantrone as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres, pharmacies and clinics worldwide, providing reliable sourcing, regulatory support and temperature‑controlled logistics for global oncology programs.
What is Irinotecan Hydrochloride Trihydrate used for?
Mizantrone (irinotecan) is used in the management of colorectal cancer, targeting the topoisomerase I pathway.
- Colorectal cancer: improves overall survival when combined with fluoropyrimidine‑based regimens. - Metastatic colorectal cancer: provides disease control in patients with advanced disease. - Advanced colorectal cancer after first‑line therapy: offers an additional therapeutic option when disease progresses.
What are the side effects of Irinotecan Hydrochloride Trihydrate?
Mizantrone may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Neutropenia: reduced white blood cell count, increasing infection risk. - Diarrhea: may be severe and require supportive care. - Nausea and vomiting: often managed with anti‑emetics. - Alopecia: temporary hair loss. - Fatigue: general tiredness and weakness. - Abdominal pain: discomfort in the stomach area.
Serious or Rare Side Effects: - Febrile neutropenia: fever with low neutrophil count, a medical emergency. - Severe diarrhea leading to dehydration or electrolyte imbalance. - Intestinal perforation: rare but life‑threatening bowel rupture. - Allergic reactions: including rash, bronchospasm, or anaphylaxis. - Hepatotoxicity: elevated liver enzymes indicating liver injury. - Severe mucositis: painful inflammation of the mouth and gastrointestinal lining.
What precautions apply to Irinotecan Hydrochloride Trihydrate?
Before initiating therapy with Mizantrone, clinicians should assess patient-specific factors and monitor for potential complications.
- Monitor blood counts: perform regular complete blood counts to detect neutropenia. - Assess liver function: evaluate hepatic enzymes and bilirubin prior to each cycle. - Evaluate bowel status: avoid use in patients with recent bowel obstruction or perforation. - Dose adjustment: consider reduced dosing in patients with hepatic impairment. - Hypersensitivity: discontinue if signs of an allergic reaction appear. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Irinotecan Hydrochloride Trihydrate interact with?
Irinotecan may interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce irinotecan exposure. - Potent UGT1A1 inhibitors (e.g., atazanavir, indinavir): increase SN‑38 levels and toxicity. - Concurrent myelosuppressive agents (e.g., cyclophosphamide): heighten risk of severe neutropenia.
Moderate Interactions (Monitor Closely): - Moderate CYP3A4 inhibitors (e.g., fluconazole, erythromycin): may modestly increase exposure. - Anticoagulants (e.g., warfarin): monitor INR as bleeding risk may rise.



