Radicava (Shionogi): Uses, Side Effects and Dosage

What RADICAVA (oral suspension) is used for:

RADICAVA (oral suspension) is a prescription medicine used to treat patients with amyotrophic lateral sclerosis (ALS).

It is not known if RADICAVA (oral suspension) is safe and effective in children.

How RADICAVA (oral suspension) works:

The exact way RADICAVA (oral suspension) works in the body of patients with ALS is unknown. It slows the loss of physical function including speech, swallowing, handwriting, cutting food and other functions.

The ingredients in RADICAVA (oral suspension) are:

Medicinal ingredient: edaravone

Non-medicinal ingredients: L-cysteine hydrochloride hydrate, phosphoric acid, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sodium hydroxide, sorbitol, water, xanthan gum

RADICAVA (oral suspension) comes in the following dosage form:

Oral suspension 105 mg/5 mL

Do not use RADICAVA (oral suspension) if:

• You are allergic to edaravone or any of the ingredients in RADICAVA (oral suspension), including sulfites. See What are the ingredients in RADICAVA (oral suspension) for a complete list of ingredients in RADICAVA (oral suspension).

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take RADICAVA (oral suspension). Talk about any health conditions or problems you may have, including if you:

• have asthma.
• are allergic to other medicines or sulfites.

• are pregnant or plan to become pregnant. It is not known if RADICAVA (oral suspension) will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if RADICAVA (oral suspension) passes into your breastmilk. You and your healthcare professional should decide if you will receive RADICAVA (oral suspension) or breastfeed.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with RADICAVA (oral suspension):

Interactions with other drugs have not been established.

How to take RADICAVA (oral suspension):

• Before using the RADICAVA (oral suspension) suspension, read the detailed Instructions for Use on how to take it at the end of the Patient Medication Information for Radicava (oral suspension).

• Take RADICAVA (oral suspension)

  • as prescribed by your healthcare professional.
  • by mouth or using a feeding tube.

  • in the morning on an empty stomach after not eating overnight for at least 8 hours.

    • If you are unable to fast overnight for 8 hours before your morning dose, you can reduce the fasting time to:

      • 4 hours if you eat a low-fat meal (400-500 calories, 25% fat),

or

• 2 hours if you take a calorie supplement (250 calories, e.g. Protein Drink).
• wait at least 1 hour after taking RADICAVA (oral suspension) before eating or drinking anything except water.

Usual dose:

Adults: Take 105 mg (5 mL) by mouth or via a feeding tube according to the following schedule:

• For the first treatment cycle of 14 days with the Starter Kit, you will take RADICAVA (oral suspension) every day for 14 days, followed by 14 days without the medicine.
• For the cycles after the first treatment cycle, you will take RADICAVA (oral suspension) daily for 10 out of 14 days, followed by 14 days without the medicine.

Overdose:

If you think you, or a person you are caring for, have taken too much RADICAVA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed Dose:

• If you miss a dose of RADICAVA (oral suspension), take it as soon as possible if it is the same day.
• Never take two doses of RADICAVA (oral suspension) on the same day to make up for a missed dose.

Possible side effects from using RADICAVA (oral suspension):

These are not all the possible side effects you may have when taking RADICAVA (oral suspension). If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects reported with RADICAVA (oral suspension) were fatigue, dizziness and headache.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Pharmacy: Store RADICAVA (oral suspension) refrigerated between 2 – 8°C and protect from light. Do not freeze. Store upright.

• Patients:

  • Store upright at room temperature between 20 – 25°C. Protect from light.
  • Discard 15 days after opening bottle or if unopened 30 days from date of shipment indicated on the carton pharmacy label.

See detailed storage information on How to store RADICAVA (oral suspension) in the Instructions for Use at the end of the Patient Medication Information.

Keep RADICAVA (oral suspension) and all medicines out of the reach and sight of children.

If you want more information about RADICAVA (oral suspension):

• Talk to your healthcare professional.

• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-productdatabase.html)); the manufacturer’s website (https://www.shionogi.com/ca/en/), or by calling 1-888-212-2253.

  INSTRUCTIONS FOR USE

  ^PrRADICAVA®

  Edaravone Oral Suspension

Read this “Instructions for Use” before you take RADICAVA (oral suspension) for the first time and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare professional about your medical condition or treatment.

Important information about measuring RADICAVA (oral suspension): Always measure your prescribed dose of RADICAVA (oral suspension) using the oral syringe provided. Ask your healthcare professional who provided the medicine any question you have about how to measure your prescribed dose. If you miss a dose of RADICAVA (oral suspension), take it as soon as possible if it is the same day. Never take two doses of RADICAVA (oral suspension) on the same day to make up for a missed dose. Do not take a dose of RADICAVA (oral suspension) on days 15 through day 28.

How to prepare RADICAVA (oral suspension): Keep this “Instructions for Use” handy when preparing the treatment.

• If your healthcare provider prescribes Starter Kit, you will receive 2 bottles of RADICAVA (oral suspension). Each bottle will contain 35 mL of RADICAVA (oral suspension) for a total of 70 mL to be used for your first treatment cycle of 14 days. Only open the second bottle when you have finished the first bottle.
• If you were not prescribed the Starter Kit, for each treatment cycle you will receive 1 bottle of RADICAVA (oral suspension) that contains a total of 50 mL of RADICAVA (oral suspension) to be used for 10 days out of 14-day periods.
• Only use the bottle adapter and the two reusable 5mL oral syringes provided with the bottle.

How to store RADICAVA (oral suspension):

• Store upright at room temperature between 20 - 25°C. Protect from light.
• Discard 15 days after opening bottle or if unopened 30 days from date of shipment indicated on the carton pharmacy label.

• Opening the bottle:

  • When you open the bottle of RADICAVA (oral suspension) for the first use, write the date you open the bottle on the bottle label.
  • After opening the bottle of RADICAVA (oral suspension), use within 15 days.
• Once a bottle of RADICAVA (oral suspension) has been opened and used, a white crust may form on the neck or on the side of the bottle. This is due to normal use and you can continue to use RADICAVA (oral suspension) as prescribed.
• Keep bottle tightly closed between each use. Protect from light.
• Throw away (discard) any RADICAVA (oral suspension) that is not used within 15 days after opening the bottle or if unopened within the 30 days from the date of shipment shown on the carton pharmacy label, whichever happens first. Ask your healthcare professional how to properly throw away (discard) RADICAVA (oral suspension) you are no longer able to use.
• Keep RADICAVA (oral suspension) and all medicines out of the reach of children.

Each RADICAVA (oral suspension) carton contains:

• 1 RADICAVA (oral suspension) bottle
• 1 bottle adapter
• 2 (5 mL) reusable oral syringes

Use a new 5 mL oral syringe and bottle adapter when using a new bottle of RADICAVA (oral suspension) (see Figure A).

Figure A

Important information:

• Keep these instructions for future use.
• Do not share RADICAVA (oral suspension) with anyone else.
• Call your healthcare professional for medical advice about side effects. You may report any suspected side effects to Health Canada (see the Reporting Side Effects section in the Patient Medication Information for RADICAVA (oral suspension)).
• People who have problems using their hands may need assistance to draw up and give the correct dose of RADICAVA (oral suspension).

How to take RADICAVA (oral suspension):

Take RADICAVA (oral suspension) as prescribed by your healthcare professional.

Dosing Information:

RADICAVA (oral suspension) has 2 different dosing schedules:

• For the first treatment cycle of 14 days with the Starter Kit, you will take RADICAVA (oral suspension) every day for 14 days, followed by 14 days without the medicine.
• For the cycles after the first treatment cycle, you will take RADICAVA (oral suspension) daily for 10 out of 14 days, followed by 14 days without the medicine.

How RADICAVA (oral suspension) will be provided:

• If your healthcare professional prescribes the Starter Kit, you will receive two (2) bottles of RADICAVA (oral suspension). Each bottle contains 35 mL of RADICAVA (oral suspension) for a total of 70 mL to deliver 14 doses. There may be some medicine that remains in each bottle after the dose on day 7 and day 14 of the first treatment cycle. Throw away (discard) any medicine that remains.
• If your healthcare professional prescribes treatment cycles after the first treatment cycle with the Starter Kit, for each treatment cycle, you will receive one (1) bottle of RADICAVA (oral suspension) that contains a total of 50 mL of RADICAVA (oral suspension) to deliver 10 doses. There may be some medicine that remains in each bottle after 10 doses. Throw away (discard) any medicine that remains.

Fasting Information:

• Take RADICAVA (oral suspension) in the morning on an empty stomach after not eating overnight for at least 8 hours. If you are unable to fast overnight for 8 hours before your morning dose, you can reduce the fasting time to:

  • 4 hours if you eat a low-fat meal (400-500 calories, 25% fat),

    or

  • 2 hours if you take a calorie supplement (250 calories, e.g. Protein Drink).
• Wait at least 1 hour after taking RADICAVA (oral suspension) before eating or drinking anything except water.

Step 1: – Before each use of RADICAVA (oral suspension): Prior to opening the bottle, turn it upside down (invert) and shake vigorously up and down for at least 30 seconds (see Figure B). Look at the liquid medicine to make sure it is mixed well. If you see any small pieces at the bottom of the bottle, invert the bottle and shake it up and down for another 30 seconds or until you can no longer see the pieces at the bottom of the bottle (see Figure B). If the liquid medicine all looks the same, you can proceed to Step 2.

Shake up and down for

at least 30 seconds

Figure B

Step 2: Open the bottle by firmly pressing down on the bottle cap and turning it counterclockwise (to the left). Place the open bottle upright on a flat surface. Do not throw away the bottle cap, you will need to replace it after taking each dose.

First time use of a bottle only. This must only be done 1 time for each bottle. Insert the ribbed end of the bottle adapter into the bottle by firmly pressing it in as far as it will go (see Figure C). Do not remove the bottle adapter.

Figure C

Step 3: Remove the oral syringe from plastic wrap and make sure the plunger is inserted all the way into the barrel. Push the oral syringe plunger toward its tip to remove excess air (see Figure D). Insert the oral syringe into the opening of the bottle adapter until it is firmly in place (see Figure E). Turn the bottle upside down and slowly pull the plunger to remove a small amount of liquid (see Figure F).

Figure D Figure E Figure F

Step 4: Keep the bottle upside down and pull the plunger until it goes up to the last line (5 mL) (see Figure G). While keeping the plunger in the same position, turn the bottle upright, and place it carefully on a flat surface. Remove the oral syringe by gently twisting or pulling it out from the bottle (see Figure H). Double check the amount of medicine before moving on to the next step (see Figure I).

Note: Do not remove the oral syringe while the bottle is upside down (medicine may leak out through the adapter).

Note: If the dose is not correct, insert the oral syringe tip firmly into the bottle adapter. Push the plunger all the way in so that the medicine flows back into the bottle. Turn the bottle upside down. Repeat Step 4.

Figure G Figure H Figure I

Step 5: Place the tip of the oral syringe in the mouth and aim towards the inside of the cheek. Slowly press down on the plunger until the oral syringe is empty. Swallow all of the medicine (see Figure J). If needed, you can use up to 8 ounces or 1 cup of water to help swallow the medicine.

Note: It is normal for a small amount of medicine to remain in the tip of the syringe after taking.

Figure J

Step 6: Leave the bottle adapter inside the bottle. Place the bottle cap on the bottle and turn the cap clockwise (to the right). Keep bottle tightly closed between each use (see Figure K).

Figure K

Step 7: Remove the plunger from the oral syringe barrel by pulling the plunger and the barrel away from each other. Rinse the oral syringe (plunger and barrel) with water only (see Figure L). Allow it to air dry.

Figure L

Step 8: When the oral syringe (plunger and barrel) is dry, put the plunger back into the oral syringe barrel. Do not throw away the oral syringe. Store the syringe in a clean, dry place.

You must complete Steps 1 through 4 under "How to take RADICAVA (oral suspension)" before starting Step 9 under "How to take a dose of RADICAVA (oral suspension) through a feeding tube."

How to take a dose of RADICAVA (oral suspension) through a feeding tube:

Step 9: Using a catheter-tip syringe, flush the feeding tube with 1 ounce (30 mL) of water (see Figure M).

Figure M

Step 10: Place the oral syringe provided (containing the 5 mL of RADICAVA (oral suspension)) into the feeding tube. Slowly push down the plunger until the oral syringe is empty (see Figure N).

Figure N

Step 11: Using a catheter-tip syringe, flush the feeding tube with 1 ounce (30 mL) of water after taking dose of RADICAVA (oral suspension) (see Figure O).

Figure O

Step 12: Leave the adapter in the bottle. Place the bottle cap on the bottle and turn it clockwise (to the right) to close the bottle. Keep the bottle tightly closed between each use (see Figure P).

Figure P

Step 13: Remove the plunger from the oral syringe barrel by pulling the plunger and barrel away from each other. Rinse the oral syringe (plunger and barrel) with water only (see Figure Q). Allow it to air dry.

Figure Q

Step 14: When the oral syringe (plunger and barrel) is dry, put the plunger back into the oral syringe barrel. Do not throw away the oral syringe. Store the oral syringe in a clean, dry place.

Manufacturer:

Shionogi Inc.

400 Campus Drive

Florham Park, NJ

USA 07932

Importer: Innomar Strategies, Inc. 3470 Superior Court Oakville, Ontario L6L 0C4

For more information, go to https://www.shionogi.com/ca/en or call 1-888-212-2253.

RADICAVA^® is a registered trademark of Shionogi Inc. © 2026 Shionogi Inc. All rights reserved. Last Revised: JUN 29, 2026