(e dar' a vone)

Brand Name(s): Radicava ORS^®

WHY is this medicine prescribed?

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

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Edaravone comes as a suspension (liquid) to take by mouth or through a feeding tube. It is usually taken in the morning on an empty stomach. If you have eaten a high-fat meal (800-1000 calories, 50% fat) the night before, you should wait at least 8 hours after eating to take edavarone. If you have eaten a low-fat meal (400-500 calories, 25% fat), you should wait at least 4 hours after eating to take edavarone. If you have eaten a meal supplement such as a protein drink (250 calories), you should wait at least 2 hours before taking edavarone. After taking edaravone, you should wait at least one hour before eating or drinking anything besides water. Take edaravone at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take edaravone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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.

Before opening the bottle, turn edaravone upside down and shake vigorously for at least 30 seconds. The dose of edaravone should only be measured with the oral syringe that comes with it. Edaravone oral suspension can also be placed in nasogastric (NG) or percutaneous endoscopic gastrostomy (PEG) tubes made of silicone or PVC. After administering edaravone through a feeding tube, the feeding tube should be flushed with at least 1 ounce (30 mL) of water using a catheter-tip syringe.

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

What SPECIAL PRECAUTIONS should I follow?

Before receiving edaravone,

• tell your doctor and pharmacist if you are allergic to edaravone, any other medications, sodium bisulfite, or any of the ingredients in edaravone suspension. 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.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Edaravone 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, call your doctor immediately or get emergency medical treatment:

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

Edaravone may cause other side effects. Call your doctor if you have any unusual problems while taking 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). The bottle should be stored upright. Throw away any unused portion 15 days after opening the bottle or 30 days after the date of shipment indicated on the pharmacy label.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 15, 2022.