Radicava is used to treat adults with amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken).

Radicava belongs to a class of medications called antioxidants. 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.

Radicava is an injection that is given by intravenous infusion over 60 minutes. Radicava ORS is an oral suspension that is taken orally by mouth, or via a feeding tube.

Radicava 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.

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

Use Radicava exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Radicava 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 this medicine.

Radicava injection is given as an infusion into a vein by a healthcare provider. The 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: 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.

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

To make sure this medicine is safe for you, 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 this medicine.

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.

If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

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

Radicava 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 to Radicava: 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 Radicava side effects 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 interact with edaravone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.