Europe — EMA
Mustophoran (Fotemustine)
GNH USA supplies Mustophoran (Fotemustine), a nitrosourea alkylating agent for metastatic melanoma and primary brain tumors.
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What is Fotemustine?
Fotemustine, the active ingredient in Mustophoran, is a nitrosourea alkylating agent presented as an injectable solution for intravenous use. It is employed in the treatment of metastatic melanoma and primary brain tumors, primarily in adult oncology patients requiring systemic chemotherapy.
GNH USA supplies Mustophoran as a licensed, GDP‑compliant international pharmaceutical product to hospitals, oncology centres, and pharmacies worldwide. The company adheres to stringent quality standards and provides regulatory documentation to support safe import and clinical use through its global distribution network.
What is Fotemustine used for?
Fotemustine is used in oncology for malignant tumors that are responsive to alkylating agents.
- Metastatic melanoma: provides disease control in patients with advanced cutaneous melanoma. - Primary brain tumors (e.g., glioblastoma): delivers cytotoxic activity against intracranial neoplasms. - Recurrent glioma: offers a therapeutic option after failure of standard radiotherapy and chemotherapy.
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 - Myelosuppression (leukopenia, thrombocytopenia) - Fatigue - Elevated liver enzymes
Serious or Rare Side Effects: - Pulmonary fibrosis - Hemorrhagic cystitis - Anaphylactic or severe hypersensitivity reactions
What precautions apply to Fotemustine?
When using Mustophoran, clinicians should observe several safety measures to minimize risk.
- Monitor blood counts: perform regular complete blood count assessments. - Assess liver function: check transaminases before and during therapy. - Evaluate pulmonary status: obtain baseline lung function and monitor for respiratory symptoms. - Avoid use in patients with severe bone marrow suppression: contraindicated if neutrophils <1.0 ×10⁹/L. - Adjust dose in renal impairment: reduce or discontinue if creatinine clearance is markedly reduced. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.
What does Fotemustine interact with?
Fotemustine can interact with other medicines, affecting efficacy or toxicity.
Major Interactions (Avoid): - Concurrent nitrosoureas or other alkylating agents: additive myelosuppression. - High‑dose radiotherapy: increased risk of tissue necrosis. - Bone‑marrow suppressive drugs (e.g., cyclophosphamide): heightened hematologic toxicity.
Moderate Interactions (Monitor Closely): - Anticoagulants (warfarin, heparin): may enhance bleeding risk. - Hepatotoxic agents (e.g., azole antifungals): require liver function monitoring.



