Edaravone
RADICAVA
What it isFree-radical scavenger; amyotrophic lateral sclerosis.
Why this oneIts modest functional benefit was first demonstrated in a narrowly defined early-disease population.
What limits itTreatment cycles are burdensome, benefit outside the studied phenotype is less certain, and sulfite can trigger hypersensitivity.
FDA-approved for
- amyotrophic lateral sclerosis (2017)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Amyotrophic lateral sclerosis | Adults | 60 mg IV over 60 min daily | 60 mg IV daily (cyclic) | 60 mg/day |
Renal Undefined
Hepatic Undefined
Cyclic dosing with 14-day drug-free periods
Instructions
- IV infusion over 60 minutes
- Initial cycle: daily x14 days then 14-day drug-free period; subsequent cycles: daily x10 of 14 days then 14-day drug-free period
- Discontinue infusion at first sign of hypersensitivity
Cautions
- Hypersensitivity reactions and anaphylaxis
- Sulfite allergic reactions (contains sodium bisulfite)
Adverse reactions
- Contusion
- Gait disturbance
- Headache
- Dermatitis
- Eczema
Pregnancy May cause fetal harm based on animal data.
Lactation No human data; excreted in rat milk.
NO BOXED WARNINGS
Principal riskBurdensome dosing cycles; unproven outside the trial subgroup
Cost, est. cash$1,000–$20,000/month
Generic entry2024
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Edaravone ballicule
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