Product image of Muphoran (Fotemustine) supplied by GNH India

Muphoran

Active Ingredient:
Fotemustine
Origin:
EU

Muphoran (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 India 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.

Manufacturer / TM Owner

Servier Hellas Pharmaceuticals Ltd

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Indications & Clinical Uses

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.

How It Works

  • Fotemustine exerts its antineoplastic activity by alkylating DNA at the O6‑guanine position, leading to intra‑ and inter‑strand cross‑links that block DNA replication and transcription. The resulting DNA damage triggers cell‑cycle arrest and apoptosis preferentially in rapidly dividing tumor cells, while sparing most normal tissues. The nitrosourea moiety releases chloroethyl and methyl radicals that facilitate the alkylation process, and the drug penetrates the blood‑brain barrier, making it effective for central nervous system malignancies.

Side Effects

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

Precautions & Warnings

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.

Avoid Interactions

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

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.

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.

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.

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.

To order Muphoran, submit an enquiry on the product page at gnhindia.com with the required quantity. GNH India 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.

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.

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.

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.

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.

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.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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