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Fumaric acid ester (immunomodulator)

Dimethyl fumarate

Brand names: Tecfidera, Skilarence (psoriasis)

Dimethyl fumarate is an oral disease-modifying therapy for relapsing-remitting multiple sclerosis.

Dosing — being independently re-sourced

ClinCalc Pro is rebuilding its dose data from primary open sources — the manufacturer SmPC (eMC), the WHO Model Formulary and other official references — under clinician review. This drug's structured dose is not yet published here. Confirm all doses against the product SmPC and your local formulary before prescribing.

Clinical monograph

How it works

It and its active metabolite activate the Nrf2 antioxidant pathway and modulate immune cell responses, producing anti-inflammatory and cytoprotective effects, though the precise mechanism in MS is not fully defined.

Prescribing in practice

  • Prolonged lymphopenia increases the risk of progressive multifocal leukoencephalopathy, so full blood count must be monitored and treatment reviewed or withdrawn if severe sustained lymphopenia develops.
  • Flushing and gastrointestinal upset are common early and may be eased by taking with food and, where appropriate, short-term symptomatic measures.
  • Check full blood count and liver and renal function before starting, and counsel patients to report symptoms of serious infection.

Monitoring

Monitor full blood count (especially lymphocytes) before and regularly during treatment, alongside liver and renal function, and remain alert for new neurological symptoms suggesting PML.

Counselling the patient

  • Flushing and stomach upset are common at first and often settle; taking with food can help.
  • Report persistent or worsening new neurological symptoms or signs of infection.
  • Attend regular blood tests as scheduled.

Evidence & guidelines

The DEFINE and CONFIRM trials showed dimethyl fumarate reduces relapse rate and MRI activity in relapsing-remitting multiple sclerosis, supporting its NICE-recommended use.

Reference: NICE TA320; NICE TA475; ABN MS-DMT; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.