Section 08 · Monograph

Edaravone

Reviewed Nov 2026FDA label

Radicava / Radicava ORSFree radical scavenger

Indications

Treatment of amyotrophic lateral sclerosis (ALS) in adultsFDA-labeled
Available as RADICAVA (intravenous infusion) and RADICAVA ORS (oral suspension), both dosed on the same cyclic scheduleFDA-labeled

Exact mechanism of therapeutic effect in ALS is unknown
Proposed to act as a free-radical scavenger that reduces oxidative stress believed to contribute to motor neuron degeneration
In vitro data suggest edaravone can eliminate lipid peroxides and hydroxyl radicals implicated in neuronal injury
Not thought to significantly inhibit or induce major cytochrome P450 enzymes or transporters

RADICAVA IV: 60 mg infused intravenously over 60 minutes
RADICAVA ORS: 105 mg (5 mL) taken orally or via feeding tube once daily in the morning after overnight fasting
Initial treatment cycle: daily dosing for 14 consecutive days, followed by a 14-day drug-free period
Subsequent cycles: dosing on 10 of 14 days, followed by a 14-day drug-free period
RADICAVA ORS fasting requirements: avoid high-fat meal within 8 hours before/after dose, low-fat meal within 4 hours, caloric supplement within 2 hours, and any food/beverage except water within 1 hour after dosing

History of hypersensitivity to edaravone or any inactive ingredient in the IV or oral suspension formulation

No clinically significant CYP-mediated or transporter-mediated drug-drug interactions identified in studies
RADICAVA ORS bioavailability is markedly reduced by food; strict fasting windows must be observed around dosing
Contains sodium bisulfite (both formulations) — theoretical additive risk with other sulfite-containing products in sulfite-sensitive patients
No formal interaction studies with other ALS therapies (e.g., riluzole) revealed clinically significant effects

Observe closely during and after each infusion/dose for signs of hypersensitivity
Monitor for sulfite-related allergic-type reactions, especially in patients with asthma
Track functional status (e.g., ALSFRS-R) and pulmonary function per routine ALS care
Assess adherence to fasting windows with RADICAVA ORS to ensure adequate drug exposure
Monitor injection/infusion site for irritation or bruising with the IV formulation

Animal reproduction studies showed decreased fetal body weight and delayed ossification/behavioral effects at clinically relevant exposures; no adequate human data — may cause fetal harm
Edaravone and metabolites are excreted in the milk of lactating rats; unknown whether present in human milk
Weigh developmental/health benefits of breastfeeding against the mother's clinical need and any potential adverse effects on the infant