Europe — EMA
Muphoran (Fotemustine)
GNH USA supplies Muphoran (Fotemustine), a nitrosourea alkylating agent for metastatic malignant melanoma and primary brain tumors.
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What is Fotemustine?
Fotemustine, the active ingredient in Muphoran, is a nitrosourea alkylating agent presented as an intravenous formulation for use in oncology patients. It is employed primarily for the treatment of metastatic malignant melanoma and certain primary brain tumors, where it exerts cytotoxic effects on rapidly dividing cancer cells.
GNH USA supplies Muphoran as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and pharmacies worldwide.
What is Fotemustine used for?
Fotemustine is an alkylating chemotherapy used in the management of aggressive solid tumours that are responsive to nitrosourea agents. - Metastatic malignant melanoma: helps to control disease progression and may improve survival. - Primary brain tumors: used to reduce tumour burden and support surgical or radiotherapy outcomes.
What are the side effects of Fotemustine?
Fotemustine may cause a range of adverse reactions that vary in frequency and severity.
Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Fatigue: persistent tiredness affecting daily activities. - Myelosuppression: reduction in white blood cells, platelets, or red cells.
Serious or Rare Side Effects: - Pulmonary fibrosis: progressive scarring of lung tissue. - Hepatic toxicity: elevated liver enzymes or hepatitis. - Severe bone‑marrow suppression: profound pancytopenia requiring transfusion or growth‑factor support.
What precautions apply to Fotemustine?
Before initiating Fotemustine therapy, clinicians should assess baseline organ function and monitor patients closely for toxicity. - Monitor blood counts: perform regular complete blood count to detect myelosuppression. - Assess liver function: check hepatic enzymes before each cycle. - Evaluate pulmonary status: baseline chest imaging for patients with respiratory risk. - Avoid use in patients with known hypersensitivity to nitrosoureas. - Use effective contraception: advise women of child‑bearing potential to avoid pregnancy during treatment. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze.
What does Fotemustine interact with?
Fotemustine can interact with other medicines, altering its efficacy or safety profile.
Major Interactions (Avoid): - Concurrent myelosuppressive chemotherapy: markedly increased risk of bone‑marrow failure. - Radiation therapy: synergistic tissue toxicity, especially in the brain. - Live vaccines: heightened risk of infection due to immunosuppression.
Moderate Interactions (Monitor Closely): - Enzyme‑inducing anticonvulsants (e.g., phenytoin): may lower Fotemustine plasma levels. - CYP450 inhibitors (e.g., azole antifungals): potential increase in toxicity. - Nephrotoxic drugs (e.g., aminoglycosides): require renal function monitoring.



