Product image of Mustophoran (Fotemustine) supplied by GNH India

Mustophoran

Active Ingredient:
Fotemustine
Origin:
EU

Mustophoran (Fotemustine)

Fotemustine, the active ingredient in Mustophoran, is a nitrosourea alkylating agent presented as a sterile solution for injection for intravenous use. It is employed in the treatment of metastatic melanoma and high‑grade brain tumors such as glioblastoma, providing cytotoxic activity against rapidly dividing cancer cells in adult patients. It is indicated for patients with advanced disease where conventional therapies have limited efficacy.

GNH India supplies Mustophoran as a licensed, GDP‑compliant international pharmaceutical supplier serving oncology centres, hospitals and specialty pharmacies worldwide, ensuring quality‑controlled sourcing and regulatory compliance for clinical use and supports clinical trial participation.

Manufacturer / TM Owner

Les Laboratoires Servier (Suresnes)

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Indications & Clinical Uses

  • Fotemustine is used in oncology for the treatment of malignant melanoma and primary brain tumors.
  • Metastatic melanoma: prolongs progression‑free survival in patients with unresectable disease.
  • Glioblastoma: provides cytotoxic effect to reduce tumor burden.
  • Primary brain tumors (e.g., anaplastic astrocytoma): contributes to disease control when combined with radiotherapy.

How It Works

  • Fotemustine generates chloroethyl radicals that alkylate the O6 position of guanine in DNA, creating interstrand cross‑links that block DNA replication and transcription. This damage triggers apoptosis in rapidly dividing tumor cells. The nitrosourea moiety also releases nitric oxide, adding to its overall cytotoxic profile.

Side Effects

Fotemustine may be associated with a range of adverse reactions, varying from mild to severe.

Common Side Effects

  • Nausea and vomiting.
  • Fatigue and general weakness.
  • Myelosuppression manifested as leukopenia or thrombocytopenia.
  • Alopecia (hair loss).
  • Transient elevation of liver enzymes.

Serious or Rare Side Effects

  • Pulmonary fibrosis.
  • Severe or opportunistic infections.
  • Hemorrhagic cystitis.
  • Delayed bone‑marrow failure.
  • Anaphylactic or hypersensitivity reactions.
  • Renal toxicity.

Precautions & Warnings

Before initiating Mustophoran therapy, several safety measures should be observed.

  • Baseline assessment: perform complete blood count and liver function tests prior to the first dose.
  • Monitoring: repeat hematology and biochemistry weekly during treatment.
  • Renal function: assess creatinine clearance because of potential nephrotoxicity.
  • Pregnancy and lactation: avoid use; the drug may cause fetal harm.
  • Concomitant myelosuppressive agents: use with caution to prevent additive bone‑marrow suppression.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Fotemustine can interact with several medicines, requiring careful management.

Major Interactions (Avoid)

  • Other alkylating or cytotoxic agents: may cause excessive myelosuppression.
  • Live vaccines: increased risk of infection due to immunosuppression.
  • Anticoagulants: heightened bleeding risk because of thrombocytopenia.
  • Strong enzyme inducers: may reduce drug exposure.

Moderate Interactions (Monitor Closely)

  • Radiation therapy: enhanced tissue toxicity when given concurrently.
  • Immunosuppressants: increased susceptibility to infections.
  • Nephrotoxic drugs: potential additive renal impairment.

Frequently Asked Questions

Mustophoran contains the alkylating agent fotemustine and is prescribed for the treatment of certain advanced cancers, specifically metastatic melanoma and high‑grade brain tumors such as glioblastoma. It is used when conventional therapies have limited effectiveness, aiming to control tumor growth and improve patient outcomes.

Fotemustine exerts its antineoplastic effect by forming chloroethyl radicals that alkylate DNA at the O6‑guanine position. This creates cross‑links that block DNA replication and transcription, leading to apoptosis of rapidly dividing tumor cells. The nitrosourea structure also releases nitric oxide, contributing to its cytotoxic activity.

The dosing regimen for Mustophoran is individualized. A qualified prescriber determines the appropriate dose, schedule, and duration based on the patient’s clinical condition, tumor type, prior therapies, and laboratory parameters. Exact dosing information should be obtained from the treating oncologist or prescribing information.

Mustophoran is classified as contraindicated during pregnancy and lactation because it can cross the placenta and may cause fetal harm or be excreted in breast milk. Women of child‑bearing potential should use effective contraception, and breastfeeding should be avoided while receiving treatment.

To request Mustophoran, submit an enquiry on the product page at gnhindia.com, specifying 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 assistance with import documentation.

The primary alternative to fotemustine is temozolomide, another oral alkylating agent used for gliomas. Fotemustine is administered intravenously and often shows activity in tumors resistant to temozolomide, but it carries a higher risk of myelosuppression and requires careful monitoring. Choice of therapy depends on tumor genetics, prior treatment response and patient tolerance.

Mustophoran must be stored at 2‑8 °C in a refrigerator. Keep the vial in its original packaging, protect it from light, and do not freeze or shake the solution. Before use, allow the product to reach room temperature if required, and follow aseptic techniques for preparation and intravenous administration.

Mustophoran is supplied as a sterile solution for injection and is given by intravenous infusion under the supervision of a qualified healthcare professional. The infusion rate and total volume are determined by the prescribing physician, and patients are monitored for infusion‑related reactions and hematologic parameters throughout the treatment course.

The most serious adverse events include severe myelosuppression (especially neutropenia and thrombocytopenia), pulmonary fibrosis, hemorrhagic cystitis, opportunistic infections, and rare but life‑threatening hypersensitivity reactions. Patients should be educated to report signs of infection, respiratory difficulty, blood in urine, or any unexpected allergic symptoms immediately.

Mustophoran is contraindicated in patients with known hypersensitivity to fotemustine or other nitrosoureas, in pregnant or breastfeeding women, and in individuals with severe bone‑marrow failure or uncontrolled infections. Caution is also advised for patients with significant hepatic or renal impairment, and those receiving other myelosuppressive therapies.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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