Edaravone

What it is and how it works

Mechanism of Action The mechanism by which RADICAVA and RADICAVA ORS exert their therapeutic effect in patients with ALS is unknown.

Indications

and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Dosage and administration (summary)

RADICAVA: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes RADICAVA ORS: The recommended dosage is 105 mg (5 mL) taken orally or via feeding tube in the morning after overnight fasting. Food should not be consumed for 1 hour after administration except water ( 2.1 , 2.3 ) For RADICAVA and RADICAVA ORS: 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 Dosage Information The recommended dosage of RADICAVA and RADICAVA ORS is as follows: RADICAVA: an intravenous infusion of 60 mg administered over a 60-min…

Contraindications

and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred . Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA and/or RADICAVA ORS

Warnings and precautions

Hypersensitivity Reactions: Advise patients to seek immediate medical care Sulfite Allergic Reactions: RADICAVA and RADICAVA ORS contain sodium bisulfite, which may cause allergic type reactions, including anaphylactic symptoms and asthmatic episodes in susceptible people Hypersensitivity Reactions Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with RADICAVA. Patients should be monitored carefully for hypersensitivity reactions.

Pregnancy

Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of RADICAVA or RADICAVA ORS 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 behav…

Storage and supply

Storage and Handling RADICAVA Store RADICAVA at up to 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F) . Protect from light. Store in overwrapped package to protect from oxygen degradation until time of use. The oxygen indicator will turn blue or purple if the oxygen has exceeded acceptable levels.

Source: Edaravone (Radicava Ors) — US FDA prescribing information, 2026-05-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.