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.
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What is Fotemustine?
Fotemustine, the active ingredient in Muphoran, is a nitrosourea alkylating agent presented as an intravenous solution for intravenous administration. It is used in the treatment of malignant melanoma and high‑grade glioma, primarily in adult oncology patients requiring systemic chemotherapy.
GNH USA supplies Muphoran as a licensed, Good Distribution Practice‑compliant international pharmaceutical supplier, providing the product to oncology centres, hospitals and pharmacies worldwide under regulated conditions. The product conforms to European Union marketing authorisation standards and is shipped in temperature‑controlled packaging to maintain stability.
What is Fotemustine used for?
Fotemustine is employed in oncology for DNA‑alkylating chemotherapy targeting aggressive skin and brain tumors.
Malignant melanoma: provides a systemic chemotherapy option for patients with unresectable or metastatic disease, aiming to reduce tumor burden and extend survival. High‑grade glioma: used in adults with recurrent or progressive glioblastoma or anaplastic astrocytoma, often after radiotherapy, to achieve tumor cell kill and disease control.
What are the side effects of Fotemustine?
Fotemustine may be associated with a range of adverse reactions, varying in frequency and severity.
Common Side Effects: - Nausea and vomiting: gastrointestinal upset occurring shortly after infusion. - Myelosuppression: leukopenia, neutropenia, and thrombocytopenia requiring regular blood‑count monitoring. - Fatigue: persistent tiredness that can affect daily activities. - Elevated liver enzymes: transient increases in ALT/AST indicating hepatic stress.
Serious or Rare Side Effects: - Pulmonary fibrosis: progressive scarring of lung tissue, potentially leading to respiratory compromise. - Severe infection: heightened risk due to neutropenia, necessitating prompt antimicrobial therapy. - Acute renal failure: rare but serious impairment of kidney function requiring close monitoring.
What precautions apply to Fotemustine?
Prior to initiating therapy, clinicians should assess baseline organ function and monitor patients closely for toxicity.
Monitor blood counts: perform regular complete blood counts to detect myelosuppression. Assess liver function: schedule periodic liver‑function tests to identify hepatotoxicity. Evaluate pulmonary status: obtain baseline and periodic lung assessments for early signs of fibrosis. Avoid use in severe renal impairment: consider dose adjustment or contraindication in patients with markedly reduced renal clearance. Pregnancy and lactation: contraindicated or unknown risk; avoid use in pregnant or breastfeeding women. Store at ambient temperature: keep in original container, protect from light and moisture.
What does Fotemustine interact with?
Fotemustine can interact with several drug classes, requiring careful management.
Major Interactions (Avoid): - Concomitant myelosuppressive agents: additive bone‑marrow toxicity may lead to severe cytopenias. - Live vaccines: immunosuppression increases risk of vaccine‑derived infection. - Strong CYP450 inducers: may reduce fotemustine plasma levels and diminish efficacy.
Moderate Interactions (Monitor Closely): - Anticoagulants: thrombocytopenia can enhance bleeding risk; monitor coagulation parameters. - Nephrotoxic drugs: combined use may exacerbate renal dysfunction. - Radiation therapy: concurrent treatment can increase normal‑tissue toxicity.



