Edaravone works by relieving the effects of oxidative stress, which may be related to the death of motor neurons (nerve cells) in people with Amyotrophic Lateral Sclerosis (ALS). Keeping motor neurons healthy may help to preserve muscle function.

Edaravone is used to treat amyotrophic lateral sclerosis.

Edaravone may also be used for purposes not listed in this medication guide.

Edaravone can cause serious allergic reactions. Get emergency medical help if you have hives, itching, trouble breathing, swelling in your face or throat, or if you feel light-headed.

Edaravone is injected into a vein through an IV. A healthcare provider will give you this injection.

Edaravone is usually given in a 28-day treatment cycle. You may need to use the medicine only during the first 2 weeks of each cycle. Your doctor will determine how long to treat you with edaravone.

This medicine must be given slowly and the IV infusion can take at least 60 minutes to complete.

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.

Comments:
-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)

You should not be treated with edaravone if you are allergic to it.

To make sure edaravone is safe for you, tell your doctor if you have ever had:

• asthma or a sulfite allergy.

It is not known whether edaravone will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether edaravone passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Call your doctor for instructions if you miss an appointment for your edaravone injection.

Since edaravone is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Edaravone can cause serious allergic reactions. The symptoms may not appear until after your IV infusion is finished.

Get emergency medical help if you have signs of an allergic reaction: hives, itching; wheezing, difficult breathing; feeling light-headed; swelling of your face, lips, tongue, or throat.

Edaravone may cause serious side effects. Call your doctor at once if you have:

• bronchospasm (wheezing, chest tightness, trouble breathing); or

• a light-headed feeling, like you might pass out.

Common side effects of edaravone may include:

• bruising;

• headache; or

• trouble walking.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with edaravone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.