Radicava (Edaravone)
Dosage & administration
See the
Instructions for UseUse a new 5 mL oral syringe and bottle adapter when using a new bottle of RADICAVA ORS (see Figure A)

Take RADICAVA ORS as prescribed by your healthcare provider.





Note:
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.



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








Marketed and distributed by:
Tanabe Pharma America, Inc.
Jersey City, NJ 07310
For more information, go to www.Radicava.com or call 1- 888-292-0058.
RADICAVA ORS®
is a registered trademarks of K.K. BCJ-94.© 2025 Tanabe Pharma America, Inc. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. 22022-3
Issued: 12/2025

















Prior to opening the bottle, turn it upside down (invert) and shake vigorously up and down for at least 30 seconds.
RADICAVA ORS can be administered by mouth or via feeding tube
RADICAVA ORS should be taken in the morning on an empty stomach after overnight fasting. Food should not be consumed for 1 hour after administration except water
12.2 PharmacodynamicsAt exposures at least 5 times higher than that of the recommended doses of RADICAVA and RADICAVA ORS, edaravone does not prolong the QT interval to any clinically relevant extent.
Type of food/caloric supplement consumed | Fasting time before and after RADICAVA ORS dose administration with regards to meal type |
High-fat meal (800-1,000 calories, 50% fat) | 8 hours before administration and one hour after administration |
Low-fat meal (400-500 calories, 25% fat) | 4 hours before administration and one hour after administration |
Caloric supplement (250 calories, e.g., protein drink) | 2 hours before administration and one hour after administration |
Administer RADICAVA ORS using a 5 mL oral syringe that comes with the product. A household teaspoon is not an adequate measuring device.
Dispose of any RADICAVA ORS that is not used within 15 days after opening the bottle or within the 30 days from the date of shipment indicated on the carton pharmacy label, which ever happens first.
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Radicava prescribing information
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
See the
Instructions for UseRead 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 questions you have about how to measure your prescribed dose. If you miss a dose,do nottake 2 doses of RADICAVA ORS the next day.Do nottake a dose of RADICAVA ORS on days 15 through 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 5 mL oral syringes provided with the bottle.Do notuse a household teaspoon to measure your medicine.
• 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 uses 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 30 days from the date of shipment shown on the carton pharmacy label, whichever 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.
• 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)

• 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.
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.o 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.o There may be some medicine that remains in each bottle after 10 doses. Throw away (discard) any medicine that remains.
- Fasting Information:
• Do noteat or drink anything 8 hours before each dose of RADICAVA ORS if you eat a high-fat meal.• Do noteat or drink anything 4 hours before each dose of RADICAVA ORS if you eat a low-fat meal.• Do noteat 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.



- Figure D


Note:
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.



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








Marketed and distributed by:
Tanabe Pharma America, Inc.
Jersey City, NJ 07310
For more information, go to www.Radicava.com or call 1- 888-292-0058.
RADICAVA ORS®
is a registered trademarks of K.K. BCJ-94.© 2025 Tanabe Pharma America, Inc. All rights reserved.
This Instructions for Use has been approved by the U.S. Food and Drug Administration. 22022-3
Issued: 12/2025

















Prior to opening the bottle, turn it upside down (invert) and shake vigorously up and down for at least 30 seconds.
RADICAVA ORS can be administered by mouth or via feeding tube
RADICAVA ORS should be taken in the morning on an empty stomach after overnight fasting. Food should not be consumed for 1 hour after administration except water
12.2 PharmacodynamicsAt exposures at least 5 times higher than that of the recommended doses of RADICAVA and RADICAVA ORS, edaravone does not prolong the QT interval to any clinically relevant extent.
Type of food/caloric supplement consumed | Fasting time before and after RADICAVA ORS dose administration with regards to meal type |
High-fat meal (800-1,000 calories, 50% fat) | 8 hours before administration and one hour after administration |
Low-fat meal (400-500 calories, 25% fat) | 4 hours before administration and one hour after administration |
Caloric supplement (250 calories, e.g., protein drink) | 2 hours before administration and one hour after administration |
Administer RADICAVA ORS using a 5 mL oral syringe that comes with the product. A household teaspoon is not an adequate measuring device.
Dispose of any RADICAVA ORS that is not used within 15 days after opening the bottle or within the 30 days from the date of shipment indicated on the carton pharmacy label, which ever happens first.
• Nasogastric (NG) tubes or percutaneous endoscopic gastrostomy (PEG) tubes made of silicone, polyvinyl chloride (PVC), or polyurethane can be used• Before and after administration, use a catheter-tip syringe to flush the tube with at least 1 ounce (30 mL) of water
RADICAVA is supplied for intravenous infusion in a single-dose polypropylene bag containing 30 mg of edaravone in 100 mL of clear, colorless aqueous solution.
RADICAVA ORS is supplied as an oral suspension in a multi-dose amber glass bottle 105 mg/5 mL of white to off-white color.
Pregnancy: Based on animal data, may cause fetal harm. (
8.1 PregnancyThere are no adequate data on the developmental risk associated with the use of RADICAVA or RADICAVA ORS in pregnant women. In animal studies, administration of edaravone to pregnant rats and rabbits resulted in adverse developmental effects (increased mortality, decreased growth, delayed sexual development, and altered behavior) at clinically relevant doses. Most of these effects occurred at doses that were also associated with maternal toxicity
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk for major birth defects and miscarriage in patients with ALS is unknown.
In rats, intravenous administration of edaravone (0, 3, 30, or 300 mg/kg/day) throughout the period of organogenesis resulted in reduced fetal weight at all doses. In dams allowed to deliver naturally, offspring weight was reduced at the highest dose tested. Maternal toxicity was also observed at the highest dose tested. There were no adverse effects on reproductive function in the offspring. A no-effect dose for embryofetal developmental toxicity was not identified; the low dose is less than the recommended human dose of 60 mg for RADICAVA on a body surface area (mg/m2) basis.
In rabbits, intravenous administration of edaravone (0, 3, 20, or 100 mg/kg/day) throughout the period of organogenesis resulted in embryofetal death at the highest dose tested, which was associated with maternal toxicity. The higher no-effect dose for embryofetal developmental toxicity is approximately 6 times the recommended human dose (RHD) for RADICAVA on a body surface area (mg/m2) basis.
The effects on offspring of edaravone (0, 3, 20, or 200 mg/kg/day), administered by intravenous injection to rats from GD 17 throughout lactation, were assessed in two studies. In the first study, offspring mortality was observed at the high dose and increased activity was observed at the mid and high doses. In the second study, there was an increase in stillbirths, offspring mortality, and delayed physical development (vaginal opening) at the highest dose tested. Reproduction function in offspring was not affected in either study. Maternal toxicity was evident in both studies at all but the lowest dose tested. The no-effect dose for developmental toxicity (3 mg/kg/day) is less than the RHD on a mg/m2basis.
Reproductive and developmental toxicology studies of edaravone using the oral route have not been conducted.
RADICAVA and RADICAVA ORS are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred
5.1 Hypersensitivity ReactionsHypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA and/or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves
5.2 Sulfite Allergic ReactionsRADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity occurs more frequently in asthmatic than non-asthmatic people.
• Hypersensitivity Reactions: Advise patients to seek immediate medical care ()5.1 Hypersensitivity ReactionsHypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA and/or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves
[see Contraindications (4)].• Sulfite Allergic Reactions: RADICAVA and RADICAVA ORS contain sodium bisulfite, which may cause allergic type reactions, including anaphylactic symptoms and asthmatic episodes in susceptible people ()5.2 Sulfite Allergic ReactionsRADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown. Sulfite sensitivity occurs more frequently in asthmatic than non-asthmatic people.