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

Lafadera

Active Ingredient:
Dimethyl Fumarate
Origin:
EU

Lafadera (Dimethyl Fumarate)

Dimethyl fumarate, the active ingredient in Lafadera, is an immunomodulating agent presented as an oral tablet for oral use. It is employed in the management of relapsing forms of multiple sclerosis in adult patients and works by modulating immune responses to reduce inflammatory activity associated with disease progression.

GNH India supplies Lafadera as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. Our distribution network ensures consistent quality and regulatory compliance across global markets.

Manufacturer / TM Owner

Elpen Pharmaceutical Co. Inc.

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Indications & Clinical Uses

Lafadera (dimethyl fumarate) is used within the disease‑modifying therapy class for multiple sclerosis and related demyelinating conditions.

  • Relapsing‑Remitting Multiple Sclerosis: reduces the frequency of clinical relapses and slows disability progression.
  • Clinically Isolated Syndrome: delays conversion to clinically definite multiple sclerosis.
  • Secondary Progressive Multiple Sclerosis with active disease: may lower relapse rates and modestly impact disease activity.

How It Works

  • Dimethyl fumarate activates the nuclear factor erythroid 2‑related factor 2 (Nrf2) transcriptional pathway, leading to increased expression of antioxidant and cytoprotective genes. This results in reduced oxidative stress, modulation of inflammatory cytokine production, and preservation of neuronal integrity, collectively contributing to its therapeutic effect in multiple sclerosis.

Side Effects

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

Common Side Effects

  • Flushing: transient redness and warmth, often mild to moderate.
  • Gastrointestinal discomfort: includes nausea, abdominal pain, and diarrhea.
  • Lymphopenia: reduction in peripheral lymphocyte count, typically mild.

Serious or Rare Side Effects

  • Progressive multifocal leukoencephalopathy (PML): rare but potentially fatal brain infection.
  • Severe infections: increased susceptibility to opportunistic infections.
  • Hepatic injury: elevated liver enzymes or hepatitis.
  • Anaphylaxis: rare severe allergic reaction requiring immediate medical attention.
  • Severe lymphopenia: profound reduction in lymphocytes increasing infection risk.

Precautions & Warnings

Prior to initiating therapy, clinicians should evaluate patient-specific factors and monitor ongoing safety parameters.

  • Monitor lymphocyte counts: baseline and periodic testing recommended to detect lymphopenia.
  • Assess hepatic function: check liver enzymes before starting and during treatment.
  • Avoid in patients with active infections: defer therapy until infection resolves.
  • Pregnancy and breastfeeding: consider only if potential benefits outweigh risks; data are limited.
  • Review concomitant immunosuppressants: increased infection risk may necessitate dose adjustments.
  • Store at ambient temperature: keep below 25 °C, protect from moisture and light in the original packaging.

Avoid Interactions

Dimethyl fumarate may interact with several medications, requiring careful assessment.

Major Interactions (Avoid)

  • Live vaccines: contraindicated during treatment due to impaired immune response.
  • Other immunosuppressive agents: may amplify infection risk.
  • Drugs causing severe lymphopenia: concurrent use should be avoided.

Moderate Interactions (Monitor Closely)

  • Antacids: may affect absorption; separate dosing by at least 2 hours.
  • Carbamazepine: may reduce dimethyl fumarate plasma levels.
  • Warfarin: monitor INR as potential alteration of anticoagulant effect.

Frequently Asked Questions

Lafadera contains dimethyl fumarate and is prescribed as a disease‑modifying therapy for adults with relapsing forms of multiple sclerosis, including relapsing‑remitting MS and clinically isolated syndrome. It helps reduce the frequency of relapses and may slow disability progression.

Dimethyl fumarate activates the Nrf2 signaling pathway, leading to increased production of antioxidant and cytoprotective proteins. This reduces oxidative stress and modulates inflammatory cytokine release, thereby protecting neural tissue and limiting the inflammatory processes that drive multiple sclerosis activity.

The dosing regimen for Lafadera is individualized by the prescribing clinician based on the patient’s condition, tolerability, and clinical response. Physicians determine the starting dose, titration schedule, and maintenance dose according to approved prescribing information and patient needs.

Safety data for dimethyl fumarate during pregnancy and lactation are limited. The drug should be used only if the potential therapeutic benefit justifies any potential risk to the fetus or infant. Women who are pregnant, planning pregnancy, or breastfeeding should discuss risks and alternatives with their healthcare provider.

To request Lafadera, 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.

Lafadera (dimethyl fumarate) is an oral disease‑modifying therapy that offers a convenient dosing schedule compared with injectable agents such as interferon‑beta or glatiramer acetate. Its mechanism via Nrf2 activation differs from the cytokine‑modulating actions of interferons, providing an alternative for patients seeking oral treatment, though safety profiles and individual response vary.

Lafadera tablets should be stored at ambient temperature, preferably below 25 °C, in the original container to protect them from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Lafadera is taken orally as a tablet. Patients should swallow the tablet whole with a glass of water, preferably with food to reduce gastrointestinal discomfort. The exact timing and titration schedule are set by the prescribing physician.

The most serious risks include progressive multifocal leukoencephalopathy (PML), severe lymphopenia that can predispose to infections, and rare cases of hepatic injury. Patients should be monitored regularly for lymphocyte counts, liver function, and any signs of infection, and should report new neurological symptoms promptly.

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

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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