GNH USA

Europe — EMA

Muphoran (Fotemustine)

GNH USA supplies Muphoran (Fotemustine), a nitrosourea alkylating agent for malignant melanoma and high‑grade glioma. Request a quote for global supply.

Fotemustine

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What is Fotemustine?

Fotemustine, the active ingredient in Muphoran, is an alkylating agent (nitrosourea) presented as an injectable solution for intravenous use. It is employed in the treatment of malignant melanoma, high‑grade glioma such as glioblastoma, and other advanced solid tumours in adult oncology patients.

GNH USA supplies Muphoran as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and specialty pharmacies worldwide, with a focus on reliable quality and regulatory compliance. Our distribution network ensures timely delivery and adherence to local import requirements.

What is Fotemustine used for?

Fotemustine is used in oncology to treat malignant tumours that are responsive to nitrosourea chemotherapy. - Malignant melanoma: improves progression‑free survival in patients with advanced disease. - High‑grade glioma (e.g., glioblastoma): provides tumor control and may extend overall survival. - Advanced solid tumours: offers therapeutic benefit in selected cases where standard options are limited.

What are the side effects of Fotemustine?

Fotemustine may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects: - Nausea and vomiting - Fatigue or weakness - Decreased blood cell counts (anemia, leukopenia, thrombocytopenia) - Elevated liver enzymes

Serious or Rare Side Effects: - Severe bone marrow suppression with risk of infection or bleeding - Pulmonary toxicity (interstitial pneumonitis) - Allergic reactions including anaphylaxis

What precautions apply to Fotemustine?

When using Fotemustine, careful monitoring and patient assessment are essential. - Monitor complete blood count: perform regular CBC to detect myelosuppression early. - Assess liver function: check transaminases before and during therapy. - Adjust dose in renal impairment: use caution and consider dose reduction in severe renal dysfunction. - Avoid in patients with known hypersensitivity to nitrosoureas: discontinue if allergic reaction occurs. - Use contraception: advise effective contraception during treatment and for several weeks after. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Fotemustine interact with?

Fotemustine can interact with several medicines; awareness of major and moderate interactions helps manage risk.

Major Interactions (Avoid): - Concurrent use of other myelosuppressive agents: may cause profound bone marrow toxicity. - Warfarin or other anticoagulants: increased risk of bleeding due to thrombocytopenia. - Live vaccines: risk of infection due to immunosuppression. - Enzyme‑inducing anticonvulsants (e.g., carbamazepine, phenytoin): may reduce fotemustine plasma levels.

Moderate Interactions (Monitor Closely): - CYP450 inhibitors (e.g., fluconazole): may increase drug exposure. - Radiotherapy to the same region: can enhance local tissue toxicity. - Nephrotoxic drugs (e.g., aminoglycosides): monitor renal function closely.

Frequently asked questions

What is Muphoran used for?+
Muphoran, containing the active ingredient fotemustine, is indicated for the treatment of malignant melanoma, high‑grade glioma such as glioblastoma, and selected advanced solid tumours where nitrosourea‑based chemotherapy is appropriate.
How does fotemustine work?+
Fotemustine alkylates DNA at the O6‑guanine position, creating cross‑links that block DNA replication and transcription. This damage leads to cell‑cycle arrest and apoptosis, especially in rapidly dividing cancer cells, while its ability to cross the blood‑brain barrier makes it useful for central nervous system tumors.
What is the usual dose of fotemustine?+
The dosing regimen for fotemustine is individualized and determined by the prescribing oncologist based on the patient’s condition, body surface area, and treatment protocol. Specific dose amounts and schedules should be obtained from the treating physician.
Is fotemustine safe in pregnancy or breastfeeding?+
There is limited clinical data on the use of fotemustine during pregnancy or lactation, and animal studies suggest potential fetal harm. Consequently, it is generally contraindicated in pregnant or breastfeeding women, and effective contraception is recommended during treatment and for several weeks afterward.
How do I order Muphoran from GNH USA?+
To order Muphoran, submit an enquiry on the product page at gnh-usa.com with 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 if needed) and the necessary import documentation.
How does fotemustine compare with other nitrosoureas or temozolomide?+
Fotemustine is a third‑generation nitrosourea with higher lipophilicity, allowing better penetration of the blood‑brain barrier compared with earlier agents like carmustine. Compared with temozolomide, fotemustine often shows activity in temozolomide‑resistant gliomas but may have a higher incidence of hematologic toxicity, requiring closer blood‑count monitoring.
How should Muphoran be stored and handled?+
Muphoran should be stored at 2‑8 °C, protected from light, and kept in its original packaging. It must not be frozen or shaken. Before use, reconstitute according to the product label in a sterile environment and administer promptly.
How is Muphoran given or administered?+
Muphoran is supplied as a sterile injectable solution that is reconstituted and administered intravenously by a qualified healthcare professional. The infusion rate and total volume are determined by the prescribing physician and the product’s preparation instructions.
What are the most serious risks to watch for with fotemustine?+
The most serious risks include severe bone‑marrow suppression leading to infection or bleeding, pulmonary toxicity such as interstitial pneumonitis, and hypersensitivity reactions that can progress to anaphylaxis. Patients should be monitored closely for signs of infection, respiratory difficulty, or allergic symptoms.
Who should not use fotemustine?+
Fotemustine is contraindicated in patients with known hypersensitivity to nitrosoureas, those with severe bone‑marrow failure, uncontrolled infections, or severe renal impairment. Caution is also advised for elderly patients and those receiving other myelosuppressive therapies.
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.
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Product details

Drug
Fotemustine
Route
Intravenous Use
Manufacturer
Servier Hellas Pharmaceuticals Ltd
Origin
EU

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