edaravone 60 mg/100mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other nervous system drugs class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Edaravone injection is used to treat amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken). Edaravone injection is in a class of medications called antioxidants. It may work to slow the nerve damage associated with the worsening of ALS symptoms.
Read the full MedlinePlus article ↗- Radicava is approved to treat ALS — amyotrophic lateral sclerosis, sometimes called Lou Gehrig's disease. It's a progressive disease that affects the nerve cells controlling your m...
- Each infusion takes about 60 minutes and is given by a healthcare provider — you won't be doing this at home on your own. The schedule works in cycles: for your first cycle, you go...
- How is the IV infusion given, and how often do I need to go in?
- The most common side effects seen in studies include bruising, changes in your walking or balance, and headache. Skin reactions like rash or eczema can also happen. The ones to act...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Edaravone — tap one for details:
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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20 mg / 100 mL
UNII ZT934N0X4W
A naturally occurring amino acid salt used as a reducing agent and antioxidant in medications. It helps prevent ingredient breakdown and may improve product stability during storage.
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UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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40 mg / 100 mL
UNII TZX5469Z6I
Sodium bisulfite is a chemical salt used as a preservative and antioxidant in medicines. It prevents discoloration and degradation of active ingredients, especially in liquid formulations and injectables.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| edaravone 60 mg/100mLthis 39822-4510-01 | XGen | 1 vial | — | — | FDA listed | — |
| edaravone 60 mg/100mL 68083-0501-01 | Gland | 1 pouch | — | AP | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 39822-4510-01 You're viewing this | 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-4510-1) / 100 mL in 1 VIAL, SINGLE-DOSE | 2024-12-02 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE 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 ▾
2 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 )
2.1Dosage 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
2.2Preparation 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.
2.4Switching 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 ▾
3 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 ▾
4 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 Cautions ▾
5 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 )
5.1Hypersensitivity 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) ] .
5.2Sulfite 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.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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) ] .
6.2Postmarketing 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 ▾
8 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.
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric Use Safety and effectiveness of edaravone injection in pediatric patients have not been established.
8.5Geriatric 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 ▾
8.1Pregnancy 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 ▾
8.4Pediatric Use Safety and effectiveness of edaravone injection in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The mechanism by which edaravone injection exerts its therapeutic effect in patients with ALS is unknown.
12.2Pharmacodynamics Cardiac Electrophysiology At exposures at least 5 times higher than that of the recommended doses of edaravone injection, edaravone does not prolong the QT interval to any clinically relevant extent.
12.3Pharmacokinetics Edaravone injection is administered by IV infusion. The maximum plasma concentration (C max ) of edaravone was reached by the end of infusion. There was a trend of more than dose-proportional increase in area under the concentration-time curve (AUC) and C max of edaravone.
With multiple-dose administration, edaravone does not accumulate in plasma. Distribution Edaravone is bound to human serum proteins (92%), mainly to albumin, with no concentration dependence in the range of 0.1 to 50 micromol/L. Edaravone has a mean volume of distribution after intravenous administration of
63.1L. Elimination The mean terminal elimination half-life of edaravone is approximately 4.5 to 9 hours. The half-lives of its metabolites are 3 to 6 hours. Following intravenous administration, the total clearance of edaravone is estimated to be
35.9L/h. Metabolism Edaravone is metabolized to a sulfate conjugate and a glucuronide conjugate, which are not pharmacologically active. The glucuronide conjugation of edaravone involves multiple uridine diphosphate glucuronosyltransferase (UGT) isoforms (UGT1A1, UGT1A6, UGT1A7, UGT1A8, UGT1A9, UGT1A10, UGT2B7, and UGT2B17).
In human plasma, edaravone is mainly detected as the sulfate conjugate, which is presumed to be formed by sulfotransferases. Excretion In Japanese and Caucasian healthy volunteer studies, edaravone was excreted mainly in the urine as its glucuronide conjugate (60-80% of the dose up to 48 hours). Approximately 6-8% of the dose was recovered in the urine as the sulfate conjugate, and < 1% of the dose was recovered in the urine as the unchanged drug.
In vitro studies suggest that the sulfate conjugate of edaravone is hydrolyzed back to edaravone, which is then converted to the glucuronide conjugate in the kidney before excretion into the urine. Specific Populations Geriatric Patients No age effect on edaravone pharmacokinetics has been found [see USE IN SPECIFIC POPULATIONS (8.5) ]. Patients with Renal Impairment Following single IV infusion of 30 mg edaravone (half the recommended dosage of edaravone injection) over 60 minutes, mean C max and AUC 0-∞ of unchanged edaravone were 1.15- and 1.20-fold greater in the subjects with mild renal impairment (eGFR 60-89 mL/min/1.73m 2 ), and were 1.25- and 1.29-fold greater in the subjects with moderate renal impairment (eGFR 30-59 mL/min/1.73m 2 ) when compared to subjects with normal renal function, respectively.
These changes in exposures are not considered to be clinically significant and therefore no dosage adjustments are necessary in patients with mild to moderate renal impairment. The effects of severe renal impairment on the pharmacokinetics of edaravone have not been studied. Patients with Hepatic Impairment Following single IV infusion of 30 mg edaravone (half of the recommended dose of edaravone injection) over 60 minutes, mean C max and AUC 0-∞ of unchanged edaravone were 1.20- and 1.07-fold greater in the subjects with mild hepatic impairment (Child-Pugh score 5 or 6), were 1.24- and 1.14-fold greater in the subjects with moderate hepatic impairment (Child-Pugh score 7 to 9), and were 1.20- and 1.19-fold greater in the subjects with severe hepatic impairment (Child-Pugh score 10 to 14) when compared to subjects with normal hepatic function, respectively.
These changes in exposures are not considered to be clinically significant and therefore no dosage adjustments are necessary in patients with hepatic impairment. Male and Female Patients No gender effect on edaravone pharmacokinetics has been found. Racial or Ethnic Groups There were no significan…
🧬 Mechanism of Action ▾
12.1Mechanism of Action The mechanism by which edaravone injection exerts its therapeutic effect in patients with ALS is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How 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
16.2Storage 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.
16.1How 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 and Handling ▾
16.2Storage 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.
📋 Description ▾
11 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
💬 Information for Patients ▾
PATIENT INFORMATION EDARAVONE INJECTION (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