Classes
DEA Class; Rx
Common Brand Names; Radicava, Radicava ORS
- Neurologics, Other
Description
Oral and intravenous antioxidant
Used for treatment of amyotrophic lateral sclerosis (ALS)
Hypersensitivity reactions, including anaphylaxis, reported
Indications
Indicated for amyotrophic lateral sclerosis (ALS)
Contraindications
Hypersensitivity to drug or any of its excipients
Adverse Effects
- Contusion (15%)
- Gait disturbance (13%)
- Headache (10%)
- Dermatitis (8%)
- Eczema (7%)
- Respiratory failure, respiratory disorder, hypoxia (6%)
- Glycosuria (4%)
- Tinea infection (4%)
- Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis
Warnings
Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) reported; monitor for hypersensitivity reactions; if hypersensitivity reactions occur, discontinue drug, treat per standard of care, and monitor until condition resolves
Contains sodium bisulfite, which may cause allergic type-reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people; sulfite sensitivity occurs more often with history of asthma
Pregnancy and Lactation
There are no adequate data on the developmental risk associated with use in pregnant women
Unknown if distributed in human breast milk
Excreted in the milk of lactating rats
Maximum Dosage
105 mg/dose PO; 60 mg/dose IV.
105 mg/dose PO; 60 mg/dose IV.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Edaravone
solution for IV infusion (Radicava)
- 30mg/100mL single-dose polypropylene bag
oral suspension (Radicava ORS)
- 105mg/5mL