Edaravone
RADICAVA
Pronunciation: e-DAR-a-voen (ra-di-KAH-va)
“Eat a raven, Radi-cave”
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 (ALS) | Adults | 60 mg IV over 60 min QD (cyclic) | 60 mg IV QD in 14-day cycles | 60 mg/day |
Renal Undefined
Hepatic Undefined
Pediatric safety and effectiveness not established.
Instructions
- Cycle 1: QD for 14 days, then 14-day drug-free period; later cycles: QD for 10 of 14 days, then 14-day drug-free period
- Give each 60 mg dose as two consecutive 30 mg bags over 60 min total (~1 mg/min)
- Do not inject other drugs into or mix with the infusion bag
- Use within 24 hours of opening overwrap; do not use if oxygen indicator is blue or purple
- Stop infusion at first sign of hypersensitivity
Available strengths
- inj 30 mg/100 mL
- susp 105 mg/5 mL
Cautions
- Hypersensitivity reactions
- Sulfite allergic reactions (contains sodium bisulfite)
Adverse reactions
- Contusion
- Gait disturbance
- Headache
- Dermatitis
- Eczema
- Respiratory failure/disorder, hypoxia
- Glycosuria
- Tinea infection
Pregnancy No adequate human data; animal studies showed adverse developmental effects at clinically relevant doses.
Lactation No human data; edaravone and metabolites excreted in rat milk.
Cost
| Strength | #/mo | generic $/unit | CostPlus | |
|---|---|---|---|---|
| 30 mg/100 mL | inj | per unit | not offered |
Generic entry2024
NO BOXED WARNINGS
Principal riskBurdensome dosing cycles; unproven outside the trial subgroup
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.
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