Edaravone
Injection, Solution · Intravenous
Uses
Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). ( 1 )
Dosage and administration
Edaravone injection: The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes ( 2.1 ) Initial treatment cycle: daily dosing for 14 days followed by a 14- day drug-free period ( 2.1 ) Subsequent treatment cycles: daily dosing for 10 days out of 14- day periods, followed by 14-day drug-free periods ( 2.1 ) 2.1 Dosage Information The recommended dosage of edaravone injection is as follows: an intravenous infusion of 60 mg administered over a 60-minute period. Administer edaravone injection according to the following schedule: An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods 2.2 Preparation and Administration Information for Edaravone Injection Edaravone injection is for intravenous infusion only. Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Vial may be inverted for use with a medical infusion set. Prepare the dose for administration by inserting a vented intravenous set through the septum of the 100 mL vial. Examine the container contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed, or if the flip off seal is not intact. Administration 30 mg/100 mL single-dose vials: Administer each 60 mg dose of edaravone injection as two consecutive 30 mg intravenous infusion single-dose vials over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]). 60 mg/100 mL single-dose vials: Administer a 60 mg dose of edaravone injection as an intravenous infusion single-dose vial over a total of 60 minutes (infusion rate approximately 1 mg per minute [1.67 mL per minute]). Promptly discontinue the infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction [see WARNINGS AND PRECAUTIONS ( 5.1 , 5.2 )] . Other medications should not be injected into the single-dose vial or mixed with edaravone injection. 2.4 Switching from Edaravone Injection to RADICAVA ORS® Patients treated with 60 mg of edaravone intravenous infusion may be switched to 105 mg (5 mL) RADICAVA ORS® using the same dosing frequency.
Dosage forms and strengths
Edaravone injection is supplied for intravenous infusion in a single-dose USP Type 1 Glass Vial containing 30 mg or 60 mg of edaravone in 100 mL of clear, colorless aqueous solution. Injection: 30 mg/100 mL in a single-dose USP Type 1 Glass Vial ( 3 ) Injection: 60 mg/100 mL in a single-dose USP Type 1 Glass Vial ( 3 )
Contraindications
Edaravone injection is 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 [see WARNINGS AND PRECAUTIONS ( 5.1 , 5.2 )] . Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in edaravone injection ( 4 )
Warnings and precautions
Hypersensitivity Reactions: Advise patients to seek immediate medical care ( 5.1 ) Sulfite Allergic Reactions: Edaravone injection contains sodium bisulfite, which may cause allergic type reactions, including anaphylactic symptoms and asthmatic episodes in susceptible people ( 5.2 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with edaravone injection. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue edaravone injection, treat per standard of care, and monitor until the condition resolves [see CONTRAINDICATIONS (4) ] . 5.2 Sulfite Allergic Reactions Edaravone injection contains 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.
Side effects
The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.1) ] Sulfite Allergic Reactions [see WARNINGS AND PRECAUTIONS (5.2) ] Most common adverse reactions (at least 10% of patients treated with edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, placebo-controlled trials, 184 patients with ALS were administered edaravone injection 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29-75) and were 59% male. Most (93%) of these patients were living independently at the time of screening. Most Common Adverse Reactions Observed During Clinical Studies Table 2 lists the adverse reactions that occurred in ≥2% of patients in the edaravone injection-treated group and that occurred at least 2% more frequently than in the placebo-treated group in randomized placebo-controlled ALS trials. The most common adverse reactions that occurred in ≥10% of edaravone injection-treated patients were contusion, gait disturbance, and headache. Table 2: Adverse Reactions from Pooled Placebo-Controlled Trials a that Occurred in ≥2% of Edaravone Injection-Treated Patients and ≥2% More Frequently than in Placebo Patients Adverse Reaction Edaravone Injection (N=184) % Placebo (N=184) % Contusion 15 9 Gait disturbance 13 9 Headache 10 6 Dermatitis 8 5 Eczema 7 4 Respiratory failure, respiratory disorder, hypoxia 6 4 Glycosuria 4 2 Tinea infection 4 2 a Pooled placebo-controlled studies include two additional studies with 231 additional patients, all using the same treatment regimen [see CLINICAL STUDIES (14) ] . 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of edaravone injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis [see WARNINGS AND PRECAUTIONS ( 5.1 , 5.2 )].
Use in specific populations
Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of edaravone injection 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 ( see ANIMAL DATA ). 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. Data Animal Data 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 edaravone injection on a body surface area (mg/m 2 ) 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 edaravone injection on a body surface area (mg/m 2 ) 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/m 2 basis. 8.2 Lactation Risk Summary There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Edaravone and its metabolites are excreted in the milk of lactating rats. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for edaravone injection and any potential adverse effects on the breastfed infant from edaravone injection or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness of edaravone injection in pediatric patients have not been established. 8.5 Geriatric Use Of the 184 patients with ALS who received edaravone injection in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age and older, including 2 patients 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of edaravone injection 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 ( see ANIMAL DATA ). 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. Data Animal Data 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 edaravone injection on a body surface area (mg/m 2 ) 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 edaravone injection on a body surface area (mg/m 2 ) 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/m 2 basis.
Pediatric use
8.4 Pediatric Use Safety and effectiveness of edaravone injection in pediatric patients have not been established.
Geriatric use
8.5 Geriatric Use Of the 184 patients with ALS who received edaravone injection in 3 placebo-controlled clinical trials, a total of 53 patients were 65 years of age and older, including 2 patients 75 years of age and older. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Description
The active ingredient in edaravone injection is edaravone, which is a member of the substituted 2-pyrazolin-5-one class. The chemical name of edaravone is [3-methyl-1-phenyl-2-pyrazolin-5-one]. The molecular formula is C 10 H 10 N 2 O and the molecular weight is 174.20. The chemical structure is: Edaravone is a white crystalline powder with a melting point of 129.7°C. It is freely soluble in acetic acid, methanol, or ethanol and slightly soluble in water or diethyl ether. Edaravone injection is a clear, colorless liquid provided as a sterile solution. 30 mg/100 mL single-dose vials: Edaravone injection is supplied for intravenous infusion in a USP Type 1 Glass Vial containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution. Individual vial will be placed in a carton (secondary packaging). Each single-dose vial contains the following inactive ingredients: L-cysteine hydrochloride hydrate (10 mg), sodium bisulfite (20 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4. 60 mg/100 mL single-dose vials: Edaravone injection is supplied for intravenous infusion in a USP Type 1 Glass Vial containing 60 mg edaravone in 100 mL isotonic, sterile, aqueous solution. Individual vial will be placed in a carton (secondary packaging). Each single-dose vial contains the following inactive ingredients: L-cysteine hydrochloride hydrate (20 mg), sodium bisulfite (40 mg). Sodium chloride is added for isotonicity and phosphoric acid and sodium hydroxide are added to adjust to pH 4. edrv-structure
Mechanism of action
12.1 Mechanism of Action The mechanism by which edaravone injection exerts its therapeutic effect in patients with ALS is unknown.
How supplied
16.1 How Supplied Edaravone injection is supplied as a 30 mg/100 mL (0.3 mg/mL) clear, colorless, sterile solution for intravenous infusion in single-dose USP Type 1 Glass Vial [see DOSAGE AND ADMINISTRATION (2.2) and HOW SUPPLIED/STORAGE AND HANDLING (16.2) ] . These are supplied in cartons as listed below. 30 mg/100 mL: NDC 39822-4500-1 single-dose glass vial, 2 vial per carton NDC 39822-4500-2 60 mg/100 mL: NDC 39822-4510-1 single-dose glass vial, 1 vial per carton NDC 39822-4510-1 16.2 Storage and Handling Store edaravone injection at up to 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. 16.1 How Supplied Edaravone injection is supplied as a 30 mg/100 mL (0.3 mg/mL) clear, colorless, sterile solution for intravenous infusion in single-dose USP Type 1 Glass Vial [see DOSAGE AND ADMINISTRATION (2.2) and HOW SUPPLIED/STORAGE AND HANDLING (16.2) ] . These are supplied in cartons as listed below. 30 mg/100 mL: NDC 39822-4500-1 single-dose glass vial, 2 vial per carton NDC 39822-4500-2 60 mg/100 mL: NDC 39822-4510-1 single-dose glass vial, 1 vial per carton NDC 39822-4510-1
Storage
16.2 Storage and Handling Store edaravone injection at up to 25°C (77°F). Excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Patient information
(e-dar-a-vone) For Intravenous Infusion What is edaravone injection? Edaravone injection is a prescription medicine used to treat people with amyotrophic lateral sclerosis (ALS). It is not known if edaravone injection is safe and effective in children. Do not receive edaravone injection if you are allergic to edaravone or any of the ingredients in edaravone injection. See the end of this leaflet for a complete list of ingredients in edaravone injection. Before you receive edaravone injection, 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 edaravone injection will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if edaravone passes into your breastmilk. You and your healthcare provider should decide if you will receive edaravone injection or breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive edaravone injection? You will be prescribed edaravone injection by a healthcare provider and told how often you will receive edaravone injection. Edaravone injection will be given by intravenous (IV) infusion into your vein. It takes about 1 hour to receive the full dose of edaravone injection. Your healthcare provider will monitor you closely during your treatment with edaravone injection. What are the possible side effects of edaravone injection? Edaravone injection may cause serious side effects including: Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving edaravone injection 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, face breathing problems dizziness itching wheezing fainting Sulfite allergic reactions. Edaravone injection contains 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, face trouble breathing or swallowing dizziness itching asthma attack (in people with asthma) wheezing fainting Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all serious side effects and allergic reactions. The most common side effects of edaravone injection include bruising (contusion), problems walking (gait disturbance), and headache. These are not all the possible side effects of edaravone injection. 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 XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411. What are the ingredients in edaravone injection? Active ingredient: edaravone Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride (tonicity agent), phosphoric acid (pH adjuster), and sodium hydroxide (pH adjuster). Manufactured in India for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814 This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 09/2024 EDAR-PIL-01
Label text from the FDA structured product label by XGen Pharmaceuticals DJB, Inc. (revised May 28, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Edaravone in 5 products
Edaravone NDC products (5)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 68083-500 | Edaravone 30 mg/100mL Injection, Solution | Gland Pharma Limited | ANDA |
| 68083-501 | Edaravone 60 mg/100mL Injection, Solution | Gland Pharma Limited | ANDA |
| 66794-259 | Edaravone 30 mg/100mL Injection, Solution | Piramal Critical Care Inc. | ANDA |
| 0781-3527 | Edaravone 30 mg/100mL Injection | Sandoz Inc | ANDA |
| 39822-4510 | Edaravone 60 mg/100mL Injection, Solution | XGen Pharmaceuticals DJB, Inc. | ANDA |
Frequently asked questions
What is Edaravone used for?
Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). ( 1 )
What are the side effects of Edaravone?
The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS (5.1) ] Sulfite Allergic Reactions [see WARNINGS AND PRECAUTIONS (5.2) ] Most common adverse reactions (at least 10% of patients treated with edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED… See the full label for the complete list.
Who makes Edaravone?
Edaravone is listed by 4 labelers in the FDA NDC directory, including Gland Pharma Limited, Piramal Critical Care Inc., Sandoz Inc, XGen Pharmaceuticals DJB, Inc..