Medically reviewed by Drugs.com. Last updated on Jun 30, 2022.
Applies to the following strengths: 30 mg/100 mL; 105 mg/5 mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Amyotrophic Lateral Sclerosis
- Initial Treatment Cycle: 60 mg once a day as IV infusion for 14 days followed by a 14-day drug-free period.
- Subsequent Treatment Cycles: 60 mg once a day as IV infusion for 10 days out of 14-day periods, followed by 14-day drug-free periods.
- Administer each 60 mg dose as 2 consecutive 30 mg IV infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]).
- Upon the first observation of any signs or symptoms of a hypersensitivity reaction, promptly discontinue the infusion.
Use: Treatment of amyotrophic lateral sclerosis (ALS)
Renal Dose Adjustments
Renal Impairment: No adjustment recommended.
Liver Dose Adjustments
- Mild to Moderate Hepatic Impairment: No adjustment recommended.
- Severe Hepatic Impairment: Dose adjustment may be required; however, no specific guidelines have been suggested. Caution is recommended.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available.
- The oxygen indicator will turn blue or purple if the oxygen has exceeded acceptable levels; avoid use in such cases.
- Use within 24 hours once the overwrap package is opened.
- Inspect visually for particulate matter and discoloration prior to administration.
- Store at up to 25 degrees Celsius (77 degrees Fahrenheit); excursions permitted from 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit).
- Protect from light, and keep in overwrapped package to protect from oxygen degradation until time of use.
- Do not inject other medications into the infusion bag or mixed with this drug.
- The efficacy of this drug was established in a 6-month clinical study of Japanese patients with ALS duration of 2 years or less who had normal respiratory function (forced vital capacity of 80% or more); 93% of these patients were living independently and retained most activities of daily living (2 points or better on each item of the ALS Functional Rating Scale - Revised).
- Hypersensitivity/allergic reactions, anaphylaxis, asthmatic episodes (throughout treatment)
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