Radicava ORS 105 mg/5 mL oral suspension

Generic name:
Edaravone - oral

Pronunciation
(e-DAR-a-vone)

Brand name(s)
Radicava ORS

Edaravone is used to treat a certain type of nerve disease called amyotrophic lateral sclerosis (ALS, also commonly called Lou Gehrig's disease). It helps to slow down the worsening of this disease. However, it is not a cure for ALS, and it does not reverse nerve damage or muscle weakness.

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using edaravone and with each treatment cycle. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth or through a feeding tube on an empty stomach as directed by your doctor. This medication is usually taken in the morning after not eating overnight (for at least 8 hours after a high-fat meal, 6 hours after a low-fat meal, 2 hours after a calorie supplement). Do not eat or drink (except for water) for at least 1 hour after taking your medication.

For the first treatment cycle, this medication is usually taken once daily for 14 days, followed by no edaravone for 14 days. After that, each treatment cycle is usually scheduled as edaravone taken once daily for 10 days out of a 14-day period, followed by no edaravone for 14 days. Follow your doctor's instructions carefully on how to use this medication.

Shake the medication well before using. Carefully measure the medication using the provided dose-measuring syringe. Do not use a household spoon because you may not get the correct dose.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Bruising, problems walking, tiredness, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using edaravone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (including sulfites such as sodium bisulfite), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• asthma

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests may be done while you are using this medication. Keep all medical and lab appointments.

If you miss a dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store the bottle upright at room temperature away from light. Discard medication 15 days after opening bottle, or 30 days from date of shipment, whichever is sooner. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.