Edaravone Injection

Edaravone injection is used to treat 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). Edaravone injection is in a class of medications called antioxidants. It may work to slow the nerve damage associated with the worsening of ALS symptoms.

Edaravone injection comes as a solution (liquid) to be injected intravenously (into a vein) over 60 minutes by a health care professional in a doctor's office or medical facility. Initially, it is usually given once a day for the first 14 days of a 28-day cycle. After the first cycle, it is given once a day for the first 10 days of a 28-day cycle. Your doctor will decide how often you are to receive edaravone based on your body's response to this medication.

Edaravone may cause serious reactions during or after you receive your infusion. Your doctor may need to stop your treatment if you experience certain side effects. Tell your doctor if you experience any of the following symptoms: wheezing or difficulty breathing, shortness of breath, cough, fainting, flushing, itching, rash, hives, swelling of the throat, tongue, or face, throat tightness, or difficulty swallowing. It is important for you to tell your doctor how you are feeling during your treatment with edaravone injection. Call your doctor right away or get immediate emergency medical attention if you experience any of these symptoms after you leave your doctor's office or medical facility.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving edaravone injection,

• tell your doctor and pharmacist if you are allergic to edaravone, any other medications, sodium bisulfite, or any of the ingredients in edaravone injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements, you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had asthma.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving edaravone, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive edaravone, call your doctor as soon as possible.

Edaravone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bruising
• difficulty walking
• headache
• red, itchy, or scaly rash

Some side effects can be serious. If you experience any of these symptoms or those in the HOW section, call your doctor immediately or get emergency medical treatment:

• difficulty breathing, chest tightness, wheezing, and coughing (especially in people with asthma)

Edaravone injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor.

Ask your pharmacist if you have any questions you have about edaravone injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Radicava^®