GNH USA

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.

Request sourcing

1
Pack/s

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.

Frequently asked questions

What is Mizantrone used for?+
Mizantrone contains irinotecan, a chemotherapy agent used primarily to treat colorectal cancer, including metastatic disease, in adult patients. It is administered as part of combination regimens to improve survival and control tumor growth.
How does Irinotecan work?+
Irinotecan is converted inside tumor cells to its active metabolite SN‑38, which inhibits DNA topoisomerase I. This prevents the re‑ligation of single‑strand DNA breaks during replication, leading to accumulation of DNA damage and cancer cell death.
What is the usual dose of Mizantrone?+
The specific dose of Mizantrone is determined by the prescribing oncologist based on the patient’s weight, disease stage, prior therapies and renal and hepatic function. Only a qualified healthcare professional should set the dosing schedule.
Is Mizantrone safe during pregnancy or breastfeeding?+
Safety data for irinotecan in pregnancy and lactation are limited. It is generally contraindicated in pregnant or nursing women because of potential fetal or infant toxicity. Clinicians should discuss risks and alternatives with patients.
How do I order Mizantrone from GNH USA?+
To request Mizantrone, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain where required) and import documentation.
How does Mizantrone compare with other topoisomerase I inhibitors?+
Mizantrone (irinotecan) is a widely used topoisomerase I inhibitor with a well‑characterized efficacy and safety profile. Compared with newer agents such as topotecan, irinotecan generally offers higher activity in colorectal cancer but may have a different toxicity spectrum, notably more severe diarrhea and neutropenia.
What are the storage and handling requirements for Mizantrone?+
Mizantrone should be stored at 2‑8 °C in a refrigerator, protected from light, and must not be frozen or shaken. The product is supplied as a sterile powder for reconstitution; reconstituted solutions should be used promptly according to the label instructions.
How is Mizantrone administered?+
Mizantrone is given by intravenous infusion after reconstitution with the appropriate diluent. The infusion rate and duration are determined by the treating physician and may be adjusted based on patient tolerance and clinical response.
What are the most serious risks associated with Mizantrone?+
The most serious risks include severe neutropenia with fever (febrile neutropenia), life‑threatening diarrhea, intestinal perforation, and allergic reactions such as anaphylaxis. Patients should be monitored closely for signs of infection, gastrointestinal toxicity and hypersensitivity.
Who should not use Mizantrone?+
Mizantrone is contraindicated in patients with known hypersensitivity to irinotecan or any of its excipients, in those with recent bowel obstruction or perforation, and in individuals with severe hepatic impairment where drug clearance is markedly reduced.
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
Vocate Φαρμακευτικη Αε
Origin
EU

Related products