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. It is employed in the treatment of metastatic malignant melanoma and certain primary brain tumors, acting to inhibit tumor cell replication. GNH USA supplies Muphoran as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres worldwide.
What is Fotemustine used for?
Fotemustine is indicated for malignant conditions where DNA‑alkylating chemotherapy is appropriate.
Metastatic malignant melanoma: provides tumor control in patients with advanced disease refractory to other therapies. Primary brain tumors (e.g., glioblastoma): used as part of a multimodal regimen to reduce tumor burden and improve survival outcomes.
What are the side effects of Fotemustine?
Common Side Effects: - Nausea and vomiting: gastrointestinal upset occurring during or after infusion. - Fatigue: persistent tiredness that may affect daily activities. - Myelosuppression: reduced white blood cells, platelets, or red cells leading to infection risk or bleeding. - Alopecia: hair loss that is typically reversible after treatment. - Elevated liver enzymes: transient changes in hepatic function tests.
Serious or Rare Side Effects: - Pulmonary fibrosis: progressive scarring of lung tissue requiring monitoring. - Severe hepatic toxicity: rare but may lead to liver failure. - Life‑threatening infections: due to profound immunosuppression. - Anaphylactic reactions: acute hypersensitivity requiring immediate intervention. - Renal failure: impaired kidney function in susceptible patients.
What precautions apply to Fotemustine?
Prior to initiating therapy, clinicians should evaluate organ function and consider patient‑specific risk factors.
Renal function: assess baseline creatinine and adjust if impairment is present. Hepatic function: monitor liver enzymes before each cycle. Bone marrow: perform complete blood counts regularly to detect myelosuppression. Pregnancy: avoid use unless benefits outweigh potential fetal risks. Concomitant radiation: limit combined use due to enhanced toxicity. Store at 2-8°C: keep refrigerated, protect from light, do not freeze.
What does Fotemustine interact with?
Fotemustine may interact with other agents that affect bone‑marrow or DNA repair pathways.
Major Interactions (Avoid): - Concurrent use with other alkylating chemotherapeutics: additive myelosuppression. - Combined radiotherapy: increased risk of severe tissue injury. - High‑dose corticosteroids: may mask infection signs.
Moderate Interactions (Monitor Closely): - Anticonvulsants that induce hepatic enzymes (e.g., carbamazepine): may alter drug clearance. - Warfarin: monitor INR closely due to potential bleeding risk.



