The Food and Drug Administration has approved an oral suspension form of edaravone (Radicava ORS) for the treatment of amyotrophic lateral sclerosis (ALS). The drug was previously available only intravenously. ALS is a progressive, neurologic disease in which the nerve cells controlling voluntary muscles are damaged, resulting in the muscles becoming weak and paralyzed. Most patients will die of respiratory failure, usually within three to five years of symptom onset. Oxidative stress may be one mechanism involved in the development of ALS.1 Edaravone is a "potent radical scavenger" that has antioxidative effects.1

Approval for the oral route of drug administration was based on a clinical trial that showed comparable levels of edaravone in the bloodstream whether given orally or intravenously. Both forms of the drug can produce the following adverse effects: bruising, gait disturbances, and headaches. Fatigue is also common with the oral form. Serious adverse effects from both forms are hypersensitivity reactions and potentially life-threatening allergic reactions if the patient has a sulfite sensitivity.

Nurses should educate the patient or family on how to administer the drug. The drug should be taken on an empty stomach in the morning, either by mouth or through a feeding tube. Patients should avoid eating or drinking, except water, for one hour after administration. If Radicava ORS is given via a feeding tube, the tube should be flushed with at least 30 mL of water before and after use, as food significantly decreases the drug's availability. The drug can be stored at room temperature and should be protected from light. The bottle of Radicava ORS should be used within 15 days of opening. Unopened bottles dated more than 30 days from date of shipment should be discarded.

For complete prescribing information for Radicava ORS, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215446s000lbl.pdf.

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