Product image of Jaxteran (Dimethyl Fumarate) supplied by GNH India

Jaxteran

Active Ingredient:
Dimethyl Fumarate
Origin:
EU

Jaxteran (Dimethyl Fumarate)

Dimethyl fumarate, the active ingredient in Jaxteran, is an immunomodulator presented as an oral formulation for oral use. It is indicated for relapsing forms of multiple sclerosis and for moderate-to-severe plaque psoriasis in adult patients effectively.

GNH India supplies Jaxteran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality‑assured product availability for qualified healthcare providers. The company adheres to EU GMP standards and provides regulatory documentation to support import and distribution across multiple regions.

Manufacturer / TM Owner

Zentiva, K.S.

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Indications & Clinical Uses

Dimethyl fumarate is employed in immune‑mediated conditions, targeting disease activity in both the central nervous system and the skin, thereby modifying relapse rates and lesion development.

  • Relapsing multiple sclerosis: reduces the frequency of clinical relapses and may slow accumulation of disability.
  • Moderate-to-severe plaque psoriasis: improves skin lesion clearance and decreases disease severity scores.

How It Works

  • Dimethyl fumarate activates the nuclear factor erythroid 2‑related factor 2 (Nrf2) transcription pathway. By modifying cysteine residues on Keap1, it releases Nrf2, allowing translocation into the nucleus where antioxidant response element genes are up‑regulated. This enhances cellular antioxidant capacity, reduces oxidative stress, and modulates pro‑inflammatory cytokine production, providing anti‑inflammatory and neuroprotective effects relevant to multiple sclerosis and psoriasis.

Side Effects

Dimethyl fumarate is associated with a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Flushing: transient warmth and redness, often occurring after the first doses.
  • Gastrointestinal discomfort: nausea, abdominal pain, or diarrhoea.
  • Upper respiratory tract symptoms: nasopharyngitis or sore throat.
  • Decreased lymphocyte count: mild reductions observed in routine blood tests.

Serious or Rare Side Effects

  • Progressive multifocal leukoencephalopathy (PML): rare opportunistic brain infection.
  • Severe hypersensitivity reactions: including Stevens‑Johnson syndrome or toxic epidermal necrolysis.

Precautions & Warnings

When prescribing dimethyl fumarate, clinicians should consider several precautionary measures to minimize risk.

  • Baseline monitoring: obtain complete blood count and liver function tests before initiating therapy.
  • Infection risk: assess for active infections and avoid use in patients with known immunosuppression.
  • Pregnancy: avoid use during pregnancy unless potential benefit justifies risk, as safety data are limited.
  • Vaccination: administer necessary vaccines prior to treatment initiation.
  • Renal or hepatic impairment: use with caution and monitor organ function regularly.
  • Store at ambient temperature: keep below 25 °C, retain in original packaging, and protect from moisture.

Avoid Interactions

Dimethyl fumarate may interact with other medicines, affecting its efficacy or safety profile.

Major Interactions (Avoid)

  • Live vaccines: concurrent use can increase risk of vaccine‑derived infection.
  • Immunosuppressants: combined therapy may heighten infection risk.

Moderate Interactions (Monitor Closely)

  • Antioxidant supplements (e.g., vitamin C, E): may attenuate Nrf2 activation.
  • CYP450 substrates: dimethyl fumarate can modestly influence metabolism of drugs processed by CYP enzymes.
  • Anticoagulants: monitor for altered bleeding risk due to potential platelet effects.

Frequently Asked Questions

Jaxteran contains dimethyl fumarate and is prescribed for adults with relapsing forms of multiple sclerosis to reduce relapse frequency and for moderate-to-severe plaque psoriasis to improve skin lesions.

Dimethyl fumarate activates the Nrf2 pathway, leading to increased expression of antioxidant genes, reduction of oxidative stress, and modulation of inflammatory cytokines, which together provide neuroprotective and anti‑inflammatory effects.

The dosing regimen for Jaxteran is determined by the prescribing clinician based on the patient’s condition, response, and tolerance. Specific dose information should be obtained from the treating healthcare professional.

Safety data for dimethyl fumarate in pregnancy and lactation are limited. It should be avoided unless the potential benefit justifies the potential risk to the fetus or infant, and the decision should be made by a qualified healthcare provider.

To order Jaxteran, 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 and any required import documentation.

The primary alternative for relapsing MS is another oral immunomodulator such as fingolimod or interferon‑beta injections. Compared with interferons, dimethyl fumarate (Jaxteran) offers oral administration and a different safety profile, while fingolimod has a distinct mechanism involving sphingosine‑1‑phosphate receptors.

Jaxteran should be stored at ambient temperature, preferably below 25 °C, in its original packaging to protect from moisture and light. Keep the product out of reach of children and do not use after the expiry date.

Jaxteran is taken orally, usually with food to reduce gastrointestinal discomfort. The tablets should be swallowed whole with a glass of water and not crushed or chewed unless otherwise directed by a healthcare professional.

Serious risks include progressive multifocal leukoencephalopathy (PML), severe lymphopenia that can predispose to infections, and rare severe hypersensitivity reactions such as Stevens‑Johnson syndrome. Patients should report any new neurological symptoms, persistent infections, or skin reactions promptly.

Jaxteran is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any excipients, those with active serious infections, and individuals receiving live vaccines. Caution is also advised for patients with severe hepatic or renal impairment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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