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 an intravenous formulation for use in oncology. It is employed to treat malignant melanoma and high‑grade glioma, targeting rapidly dividing tumor cells in adult patients.

GNH India supplies Mustophoran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Les Laboratoires Servier (Suresnes)

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Indications & Clinical Uses

  • Fotemustine is used in oncology to address aggressive solid tumours that are responsive to alkylating chemotherapy.
  • Malignant melanoma: provides disease control and may extend survival in advanced cases.
  • High‑grade glioma: used as part of a chemotherapy regimen to reduce tumour burden.
  • Recurrent glioma: employed when standard therapies have failed to achieve adequate response.

How It Works

  • Fotemustine exerts its antineoplastic effect by alkylating DNA and forming interstrand cross‑links, which impede DNA replication and transcription. The resulting DNA damage triggers cell‑cycle arrest and apoptosis, preferentially affecting rapidly proliferating tumor cells while sparing most normal tissues.

Side Effects

Fotemustine may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting
  • Fatigue or weakness
  • Myelosuppression (decreased blood cell counts)
  • Alopecia (hair loss)
  • Elevated liver enzymes
  • Mild fever or chills

Serious or Rare Side Effects

  • Severe bone‑marrow suppression leading to infection or bleeding
  • Pulmonary fibrosis or interstitial lung disease
  • Acute hepatic failure
  • Life‑threatening allergic reactions (anaphylaxis)
  • Seizures or neurological toxicity
  • Secondary malignancies

Precautions & Warnings

  • When using Fotemustine, clinicians should observe several safety measures.
  • Monitor blood counts: perform regular complete blood count assessments.
  • Assess liver function: check hepatic enzymes before and during therapy.
  • Evaluate pulmonary status: screen for pre‑existing lung disease.
  • Avoid in patients with known hypersensitivity to nitrosoureas.
  • Use caution in renal impairment: adjust monitoring frequency.
  • Store at ambient temperature: keep in original packaging, protect from moisture and light.

Avoid Interactions

Fotemustine can interact with other medicines, requiring careful management.

Major Interactions (Avoid)

  • Concurrent use with other alkylating agents (excessive bone‑marrow toxicity)
  • Combination with radiotherapy (enhanced tissue damage)
  • Co‑administration with strong myelosuppressive drugs (risk of severe cytopenia)

Moderate Interactions (Monitor Closely)

  • Anticonvulsants that induce hepatic enzymes (may reduce efficacy)
  • Non‑steroidal anti‑inflammatory drugs (increase bleeding risk)
  • Warfarin (potential alteration of anticoagulant effect)

Frequently Asked Questions

Mustophoran contains the chemotherapeutic agent fotemustine and is used to treat malignant melanoma and high‑grade glioma, including recurrent brain tumours, in adult patients. It belongs to the nitrosourea class of alkylating agents and is administered intravenously under specialist supervision.

Fotemustine works by adding alkyl groups to DNA, creating cross‑links that prevent DNA replication and transcription. This damage triggers cell‑cycle arrest and programmed cell death, preferentially affecting rapidly dividing cancer cells while sparing most normal tissues.

The dosing regimen for Mustophoran is determined by the treating oncologist based on the patient’s condition, body surface area, and clinical response. Physicians calculate the appropriate intravenous dose and schedule according to established oncology protocols.

Fotemustine is classified as contraindicated in pregnancy because it can cause fetal harm. Women of child‑bearing potential should use effective contraception. Breastfeeding is not recommended, as the drug may be excreted in milk and affect the infant.

To order 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 any cold‑chain requirements) and necessary import documentation.

Mustophoran (fotemustine) is similar to other nitrosoureas such as carmustine and lomustine in its mechanism of DNA alkylation, but it is formulated for intravenous use and has a distinct pharmacokinetic profile that may offer different efficacy and toxicity patterns, especially in melanoma and high‑grade glioma.

Mustophoran should be stored at ambient temperature, below 25 °C, in its original container. Protect the product from moisture, direct sunlight and extreme temperatures. Do not freeze. Follow standard aseptic handling procedures for intravenous solutions.

Mustophoran is given as an intravenous infusion under the supervision of qualified healthcare professionals. The infusion rate and duration are set by the prescribing oncologist and nursing staff, typically in a controlled clinical setting to monitor for immediate reactions.

The most serious risks include severe bone‑marrow suppression leading to infection or bleeding, pulmonary fibrosis, acute liver failure, and life‑threatening allergic reactions. Patients should be closely monitored for signs of infection, respiratory difficulty, jaundice or rash during treatment.

Mustophoran is contraindicated in patients with known hypersensitivity to fotemustine or other nitrosoureas, in those with severe bone‑marrow failure, uncontrolled liver disease, or active pulmonary fibrosis. It should also be avoided in pregnant women and in individuals who cannot receive intravenous therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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