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Rare Neurological Disorders Pregnancy: There are no adequate data on the developmental risk associated with use in pregnant women. In animal studies, administration of edaravone to pregnant rats and rabbits resulted in adverse developmental effects (increased mortality, decreased growth, delayed sexual development and altered behaviour) at clinically relevant doses, most of which occurred at doses also associated with maternal toxicity; a no-effect dose for embryofetal developmental toxicity was not identified in rats (US labelling §8.1).

Edaravone

Brand names: Radicava

Edaravone is a free-radical scavenger used to slow functional decline in amyotrophic lateral sclerosis (motor neurone disease) in selected patients.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Intravenous (RADICAVA): 60 mg per dose. Oral suspension (RADICAVA ORS): 105 mg (5 mL) per dose
Route: Intravenous infusion over a 60-minute period, given as two consecutive 30 mg intravenous infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute, i.e. 3.33 mL per minute); OR 105 mg (5 mL) oral suspension taken by mouth or via a nasogastric or PEG feeding tube
Frequency: Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period. Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods
No UK SPC (eMC) record was fetched in this bundle — all figures are from the US prescribing information for RADICAVA / RADICAVA ORS (Shionogi, label date 2026-05-05) and must be verified against the UK SPC before use. Indication is amyotrophic lateral sclerosis. IV PREPARATION AND ADMINISTRATION: for intravenous infusion only; do not use if the oxygen indicator has turned blue or purple before opening the package; once the overwrap package is opened, use within 24 hours; inspect visually for particulate matter and discoloration; promptly discontinue the infusion on the first observation of any signs or symptoms consistent with a hypersensitivity reaction; other medications must not be injected into the infusion bag or mixed with RADICAVA. ORAL SUSPENSION: invert the bottle and shake vigorously up and down for at least 30 seconds before opening; take in the morning on an empty stomach after overnight fasting, and do not consume food for 1 hour after administration except water. Label fasting table: high-fat meal (800-1,000 calories, 50% fat) — 8 hours before and 1 hour after the dose; low-fat meal (400-500 calories, 25% fat) — 4 hours before and 1 hour after; caloric supplement (250 calories, e.g. a protein drink) — 2 hours before and 1 hour after. Administer using the 5 mL oral syringe supplied — a household teaspoon is not an adequate measuring device. Discard any oral suspension not used within 15 days of opening the bottle, or within 30 days of the shipment date on the carton pharmacy label, whichever comes first. FEEDING TUBE: nasogastric or PEG tubes made of silicone, polyvinyl chloride or polyurethane can be used; flush the tube with at least 30 mL (1 ounce) of water before and after administration using a catheter-tip syringe. SWITCHING: patients treated with 60 mg RADICAVA intravenous infusion may be switched to 105 mg (5 mL) RADICAVA ORS using the same dosing frequency, following the oral suspension food recommendations. PAEDIATRIC: safety and effectiveness of RADICAVA or RADICAVA ORS in paediatric patients have not been established — verify any under-18 use against a children's formulary.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • History of hypersensitivity to edaravone or to any of the inactive ingredients in the product — hypersensitivity reactions and anaphylactic reactions have occurred

Side effects

  • Contusion (most common, at least 10% of patients and greater than placebo)
  • Gait disturbance (most common, at least 10% of patients and greater than placebo)
  • Headache (most common, at least 10% of patients and greater than placebo)
  • Hypersensitivity reactions — a labelled warning; discontinue the infusion promptly at the first sign or symptom
  • Sulfite allergic reactions — a labelled warning (the product contains sodium bisulfite)

Clinical monograph

How it works

It acts as an antioxidant that scavenges reactive oxygen species, thereby reducing oxidative stress thought to contribute to motor neurone injury.

Prescribing in practice

  • Hypersensitivity and anaphylactic reactions can occur, so administer with appropriate monitoring and resuscitation provision available for intravenous use.
  • Sodium bisulfite-containing formulations may provoke reactions in susceptible individuals, including those with sulfite sensitivity.
  • Treatment is given in intermittent cycles, and an oral formulation is available in some settings as an alternative to the intravenous route.

Monitoring

Monitor for hypersensitivity reactions during and after administration and assess functional status to judge ongoing benefit.

Counselling the patient

  • Report any rash, breathlessness, swelling or itching during or after treatment.
  • Treatment is given in repeated cycles; keep to the scheduled appointments.
  • Discuss any history of sulfite sensitivity with the team.

Evidence & guidelines

A randomised placebo-controlled trial demonstrated a reduction in the rate of functional decline in a defined ALS subgroup.

Reference: MCI186 ALS19 trial Lancet Neurology 2017; 16(7):505-512; MHRA 2023; FDA label; EFNS ALS Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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