Edaravone is used to treat adults with amyotrophic lateral sclerosis (ALS).

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

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Edaravone is usually given in a treatment cycles. 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.

Edaravone injection is given as an infusion into a vein by a healthcare provider. Edaravone injection must be given slowly and the IV infusion can take at least 60 minutes to complete.

Carefully follow instructions provided on when to stop eating to take the medicine. You should stop eating at bedtime the night before.

Take the oral suspension in the morning on an empty stomach. Do not eat for at least 1 hour after each dose.

The oral suspension can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Read and carefully follow any instructions for setting up and using the medicine before preparing your first dose. Ask your doctor or pharmacist if you do not understand these instructions.

Turn the bottle upside down and shake the oral suspension (liquid) for at least 30 seconds. Measure a dose with the supplied measuring device (not a kitchen spoon). Throw away unused medicine 15 days after opening .

Store the oral suspension in an upright position at room temperature, away from light. Throw away any unopened medicine within 30 days after receiving the medicine.

Usual Adult Dose for Amyotrophic Lateral Sclerosis:

Initial treatment cycle:
-Intravenous infusion: 60 mg once daily over 60 minutes for 14 days, followed by a 14-day drug-free period.
-Oral suspension: 105 mg (5 mL) once daily orally or via feeding tube in the morning after overnight fasting for 14 days, followed by a 14-day drug-free period.
Subsequent treatment cycles:
-Intravenous infusion: 60 mg once daily over 60 minutes for 10 days out of 14-day periods, followed by 14-day drug-free periods.
-Oral suspension: 105 mg (5 mL) once daily orally or via feeding tube in the morning after overnight fasting for 10 days out of 14-day periods, followed by 14-day drug-free periods.

Oral administration relative to type of food consumption:
-High-fat meal (800 -1000 calories, 50% fat): 8 hours before administration and one hour after administration.
-Low-fat meal (400-500 calories, 25% fat): 4 hours before administration and one hour after administration.
-Caloric supplement (250 calories, e.g., protein drink): 2 hours before administration and one hour after administration.

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]).
-Discontinue infusion at first sign of hypersensitivity reaction.

Use: For the treatment of Amyotrophic lateral sclerosis (ALS)

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

Tell your doctor if you have ever had:

• asthma or a sulfite allergy.

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

Ask a doctor if it is safe to breastfeed while using edaravone.

Call your doctor for instructions if you miss a dose or an appointment for your medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Edaravone can cause serious allergic reactions. Some side effects may occur during or after the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, 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

• problems with balance or 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 affect edaravone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.