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Radicava and Radicava ORS

Generic name: edaravone

What are Radicava and Radicava ORS?

Radicava and Radicava ORS are prescription medicines used to treat people with amyotrophic lateral sclerosis (ALS).

It is not known if Radicava or Radicava ORS are safe and effective in children.

Who should not use Radicava and Radicava ORS?

Do not receive Radicava or Radicava ORS if you are allergic to edaravone or any of the ingredients in Radicava and Radicava ORS. See below for a complete list of ingredients in Radicava and Radicava ORS.

What should I tell my healthcare provider before using Radicava and Radicava ORS?

Before you take Radicava or Radicava ORS, tell your healthcare provider about all of your medical conditions, including if you:

  • have asthma.
  • are allergic to other medicines.
  • are pregnant or plan to become pregnant. It is not known if Radicava or Radicava ORS will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Radicava or Radicava ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive Radicava or Radicava ORS or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use Radicava and Radicava ORS?

How should I use Radicava?

  • You will be prescribed Radicava by a healthcare provider and told how often you will receive Radicava.
  • Radicava will be given by intravenous (IV) infusion into your vein.
  • It takes about 1 hour to receive the full dose of Radicava.
  • Your healthcare provider will monitor you closely during your treatment with Radicava.

How should I take Radicava ORS?

  • See the detailed Instructions for Use on how to take Radicava ORS below.
  • You will be prescribed Radicava ORS by a healthcare provider and told how often you will take Radicava ORS.
  • Radicava ORS is to be taken by mouth or by using a feeding tube.
  • Radicava ORS should be taken in the morning on an empty stomach. You should stop eating at bedtime.
    • Do not eat or drink anything 8 hours before each dose of Radicava ORS if you eat a high-fat meal.
    • Do not eat or drink anything 4 hours before each dose of Radicava ORS if you eat a low-fat meal.
    • Do not eat or drink anything 2 hours before each dose of Radicava ORS if you take a calorie supplement.
  • You should wait at least 1 hour after taking your medicine before eating or drinking anything except water.

What are the possible side effects of Radicava and Radicava ORS?

Radicava and Radicava ORS may cause serious side effects including:

1. Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving Radicava or taking Radicava ORS and can happen after your medicine has been given. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:

  • hives
  • swelling of the lips, tongue andface
  • fainting
  • breathing problems
  • dizziness
  • itching
  • wheezing

2. Sulfite allergic reactions. Radicava and Radicava ORS contain sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe allergic reactions, for example, asthma episodes, in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:

  • hives
  • swelling of the lips, tongue and face
  • wheezing
  • trouble breathing or swallowing
  • dizziness
  • fainting
  • itching
  • asthma attack (in people with asthma)

Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions.

The most common side effects of Radicava and Radicava ORS include bruising (contusion), problems walking (gait disturbance), and headache.

These are not all the possible side effects of Radicava and Radicava ORS. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to www.fda.gov/medwatch or Mitsubishi Tanabe Pharma America, Inc. at 1-888-292- 0058.

How should I store Radicava ORS?

  • Store Radicava ORS upright at room temperature between 68°F to 77°F (20°C to 25°C). Protect from light.
  • Opening the bottle:
    • When you open the bottle of Radicava ORS for the first use, write the date you open the bottle on the bottle label.
    • After opening the bottle of Radicava ORS, use within 15 days.
  • After a bottle of Radicava ORS 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 Radicava ORS can continue to be used as prescribed.
  • Keep bottle tightly closed between each use.
  • Throw away (discard) any Radicava ORS that is not used within 15 days after opening the bottle or within the 30 days from the date of shipment shown on the carton pharmacy label, which ever happens first. Ask your pharmacist how to properly throw away (discard) Radicava ORS you are no longer able to use.
  • Keep Radicava ORS and all medicines out of the reach of children.

What are the ingredients in Radicava and Radicava ORS?

Active ingredient: edaravone

Inactive ingredients:

Radicava: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide.

Radicava ORS: L-cysteine hydrochloride hydrate, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sorbitol, and xanthan gum. Phosphoric acid and sodium hydroxide are added to adjust to pH 4.

For more information, go to www.Radicava.com or call 1-888-292-0058.

Instructions for use for Radicava ORS

Radicava (ra di ká vah) ORS
(edaravone)
oral suspension

Read this Instructions for Use before you take Radicava ORS 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 provider about your medical condition or treatment.

Important information about measuring Radicava ORS: Always measure your prescribed dose of Radicava ORS using the oral syringe provided. Ask your healthcare provider or pharmacist who provided the medicine any question you have about how to measure your prescribed dose. If you miss a dose, do not take 2 doses of Radicava ORS the next day. Do not take a dose of Radicava ORS on days 15 through day 28.

How to prepare Radicava ORS:

Keep this Instructions for Use handy when preparing the treatment.

  • If your healthcare provider prescribes a Starter Kit, you will receive 2 bottles of Radicava ORS. Each bottle will contain 35 mL of Radicava ORS 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 ORS that contains a total of 50 mL of Radicava ORS. After the first treatment cycle, Radicava ORS is to be used for 10 days out of 14 day periods.
  • Only use the bottle adapter and the 2 reusable 5mL oral syringes provided with the bottle. Do not use a household teaspoon to measure your medicine.

How to store Radicava ORS:

  • Store Radicava ORS upright at room temperature between 68°F to 77°F (20°C to 25°C). Protect from light.
  • Opening the bottle:
    • When you open the bottle of Radicava ORS for the first use, write the date you open the bottle on the bottle label.
    • After opening the bottle of Radicava ORS, use within 15 days.
  • After a bottle of Radicava ORS 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 Radicava ORS can continue to be used as prescribed.
  • Keep bottle tightly closed between each use.
  • Throw away (discard) any Radicava ORS that is not used within 15 days after opening the bottle or within the 30 days from the date of shipment shown on the carton pharmacy label, which ever happens first. Ask your pharmacist how to properly throw away (discard) Radicava ORS you are no longer able to use.
  • Keep Radicava ORS and all medicines out of the reach of children.

Each Radicava ORS carton contains:

  • 1 Radicava ORS bottle
  • 1 bottle adapter
  • 2 (5 mL) reusable oral syringes

Each Radicava ORS carton contains 1 Radicava ORS 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 ORS (see Figure A).

Important information:

  • Keep these instructions for future use.
  • Do not share Radicava ORS with anyone else.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • People who have problems using their hands may need assistance to draw up and give the correct dose of Radicava ORS.

How to take Radicava ORS:

Take Radicava ORS as prescribed by your healthcare provider.

Dosing Information:
Radicava ORS has 2 different dosing schedules:

  • For the first treatment cycle, you will take Radicava ORS every day for 14 days, followed by 14 days without the medicine.
  • For the cycles after the first treatment cycle, you will take Radicava ORS daily for 10 out of 14 days, followed by 14 days without the medicine.

How Radicava ORS will be provided:

  • If your healthcare provider prescribes the Starter Kit, you will receive 2 bottles of Radicava ORS. Each bottle contains 35 mL of Radicava ORS 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 you were not prescribed the starter kit, for each treatment cycle, you will receive 1 bottle of Radicava ORS that contains a total of 50 mL of Radicava ORS 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:

  • Do not eat or drink anything 8 hours before each dose of Radicava ORS if you eat a high-fat meal.
  • Do not eat or drink anything 4 hours before each dose of Radicava ORS if you eat a low-fat meal.
  • Do not eat or drink anything 2 hours before each dose of Radicava ORS if you take a calorie supplement.
  • You should wait at least 1 hour after taking your medicine before eating or drinking anything except water.

Step 1 – Before each use of Radicava ORS:

Before 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 bottle up and down for at least 30 seconds.image
Shake up and down for at least 30 seconds

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.

Insert the ribbed end of the bottle adapter into the bottle by firmly pressing it in as far as it will go.image

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).

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).image

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). Check the amount of medicine again 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.

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). Check the amount of medicine again before moving on to the next step (see Figure I).image

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.

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.image

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).

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.image

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. Allow it to air dry.

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. Allow it to air dry.image

Step 8:

When the oral syringe (plunger and barrel) are 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 ORS" before starting Step 9 under "How to take a dose of Radicava ORS oral suspension through a feeding tube.”

How to take a dose of Radicava ORS 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).

Using a catheter-tip syringe, flush the feeding tube with 1 ounce (30 mL) of water.image

Step 10.

Place the oral syringe provided (containing the 5 mL of Radicava ORS) into the feeding tube. Slowly push down the plunger until the oral syringe is empty (see Figure N).

Place the oral syringe provided (containing the 5 mL of Radicava ORS) into the feeding tube. Slowly push down the plunger until the oral syringe is empty.image

Step 11.

Using a catheter-tip syringe, flush the feeding tube with 1 ounce (30 mL) of water after taking the dose of Radicava ORS (see Figure O).

Using a catheter-tip syringe, flush the feeding tube with 1 ounce (30 mL) of water after taking the dose of Radicava ORS.image

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).

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.image

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.

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.image

Step 14.

When the oral syringe (plunger and barrel) are 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.

Instructions for use approved 5/2022.

Source: Food and Drug Administration (FDA). Last updated May 12, 2022.