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Fumaric acid ester (immunomodulator)

Dimethyl fumarate

Brand names: Tecfidera, Skilarence (psoriasis)

Adult dose

Dose: MS: start 120mg BD for 7 days, then 240mg BD; Psoriasis: start 30mg/day, titrate per protocol to max 720mg/day
Route: Oral
Frequency: BD

Clinical pearls

  • NICE TA320: relapsing-remitting MS; NICE TA475 psoriasis
  • ABN MS-DMT prescribing guideline
  • Monitor lymphocyte count; PML risk increases with prolonged severe lymphopaenia (<0.5)
  • Diroximel fumarate is alternative with better GI tolerability

Contraindications

  • Severe lymphopaenia
  • Severe renal/hepatic impairment
  • Active serious infection
  • Pregnancy
  • Hypersensitivity

Side effects

  • Flushing (very common — give 30 min before with food, may co-administer aspirin 75mg)
  • GI upset
  • Lymphopaenia
  • Progressive multifocal leukoencephalopathy (PML — JCV-associated)
  • Hepatotoxicity
  • Proteinuria
  • Anaphylaxis (rare)

Interactions

  • Other immunosuppressives
  • Live vaccines

Monitoring

  • FBC (especially lymphocytes)
  • LFTs
  • Renal function
  • Urinalysis
  • JCV antibody if prolonged lymphopaenia
  • Pregnancy

Reference: BNF; NICE TA320; NICE TA475; ABN MS-DMT; SmPC; https://bnf.nice.org.uk/drugs/dimethyl-fumarate/. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.