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Rare Neurological Disorders Pregnancy: Avoid — limited data; ALS in pregnancy is rare; discuss with specialist

Edaravone

Brand names: Radicava

Adult dose

Dose: 60 mg IV once daily for 14 days, then 14-day drug-free period per cycle; initial 60 mg daily for 14 consecutive days (initial cycle), then for 10 of 14 days per subsequent cycle
Route: IV infusion over 60 minutes
Frequency: Cyclical — 14 days on, 14 days off
Max: 60 mg per day
Dilute in 100 mL sodium chloride 0.9%. Do not add other drugs to same IV line. Available for a subset of ALS patients meeting eligibility criteria. Oral form (Radicava ORS) approved in US 2022.

Paediatric dose

Dose: Seek specialist opinion N/A/kg
Route: IV
Frequency: N/A
Max: N/A
Not established in paediatrics — ALS is rare in children; seek specialist opinion

Dose adjustments

Renal

Use with caution in renal impairment — edaravone and metabolites renally excreted; limited data; consult specialist

Hepatic

Use with caution in hepatic impairment — limited data

Paediatric weight-based calculator

Not established in paediatrics — ALS is rare in children; seek specialist opinion

Clinical pearls

  • Mechanism: free radical scavenger — edaravone is a potent antioxidant that scavenges hydroxyl radicals and peroxynitrite; oxidative stress is implicated in motor neuron death in ALS; reduces oxidative damage to neural tissue
  • MCI186 ALS 19 trial (Lancet Neurology 2017): edaravone vs placebo in a selected ALS subgroup (early-stage, rapid progression, ALSFRS-R above 2 on all items) — significant slowing of functional decline (32.5% difference at 24 weeks); trial positive in this specific subgroup
  • Eligibility criteria: edaravone is ONLY for early-stage ALS patients meeting strict criteria; not for late-stage or slower-progressing ALS; approved in Japan 2015, US 2017, Canada 2018; MHRA 2023 granted approval for UK
  • MHRA 2023: edaravone licensed in UK for adults with ALS who meet eligibility criteria (ALSFRS-R 2 or above on all items, FVC above 80% predicted, disease duration under 2 years); NICE assessment ongoing
  • Sulfite allergy WARNING: Radicava IV formulation contains sodium bisulfite — asthmatics and sulfite-sensitive patients may develop severe hypersensitivity including anaphylaxis; detailed allergy history required before prescribing
  • Modest benefit: effects are disease-slowing, not reversing; magnitude of benefit is modest; must be discussed openly with patients and families in context of ALS prognosis

Contraindications

  • Known hypersensitivity to edaravone or sodium bisulfite (excipient — allergy risk in sulfite-sensitive patients including asthmatics)
  • Severe renal or hepatic impairment (limited data)

Side effects

  • Bruising
  • Gait disturbance
  • Headache
  • Hypersensitivity reactions (including anaphylaxis — sulfite excipient; asthmatic patients at particular risk)
  • Respiratory failure (disease progression may be confused with drug effect)

Interactions

  • Anticoagulants and antiplatelets (edaravone has antiplatelet-like effects — monitor bleeding risk)
  • No significant CYP450 interactions

Monitoring

  • ALSFRS-R (ALS Functional Rating Scale-Revised) — monthly disease progression tracking
  • FVC (forced vital capacity — respiratory monitoring in ALS)
  • Signs of hypersensitivity during infusion (especially asthmatics)
  • Renal function
  • Liver function

Reference: BNFc; BNF 90; MCI186 ALS19 trial Lancet Neurology 2017;16(7):505-512; MHRA 2023; FDA label; EFNS ALS Guidelines. Verify against your local formulary and the latest BNF before prescribing.

Related

Curated clinical cross-links plus same-class fallbacks.

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