Edaravone

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Edaravone Injection:
• The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes as follows ( 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:
• 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
• Do not use if the oxygen indicator has turned blue or purple before opening the package .
• Once the overwrap package is opened, use within 24 hours [see How Supplied/Storage and Handling (16.1 , 16.2 )].
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Discard unused portion.
• Administration Administer a 60 mg dose of edaravone injection as two consecutive 30 mg intravenous infusion bag over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 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 infusion bag or mixed with edaravone injection.
• 2.4 Switching from Edaravone Injection to RADICAVA ORS Patients treated with 60 mg of edaravone injection intravenous infusion may be switched to 105 mg (5 mL) Radicava ORS using the same dosing frequency.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

Safety and effectiveness of edaravone injection in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.

Quoted from the official label, section “Geriatric Use”.

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 Piramal Crtical Care, Inc. at 1-800-414-1901 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 to ­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 )].

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patients to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Advise patients to seek immediate medical care if they experience signs or symptoms of a hypersensitivity reaction [see Warnings and Precautions (5.1) ]. Sulfite Allergic Reactions Advise patients about potential for sulfite sensitivity. Inform patients that edaravone injection contains sodium bisulfite, which may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, and to seek immediate medical care if they experience these signs or symptoms [see Warnings and Precautions (5.2) ]. Pregnancy and Breastfeeding Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during edaravone injection therapy [see Use in Specific Populations (8.1) ]. Advise patients to notify their healthcare provider if they intend to breastfeed or are breastfeeding an infant [see Use in Specific Populations (8.2) ]. Manufactured for:
• Piramal Crtical Care, Inc. Bethlehem, PA 18017, USA Issued:
• 09/2023 PATIENT INFORMATION Edaravone Injection (e-dar-a-vone) for intravenous use 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:
• 1. 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
• fainting
• breathing problems
• dizziness
• itching
• wheezing 2. 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
• 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 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 Piramal Critical Care, Inc. at 1-800-414-1901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. What are the ingredients in Edaravone injection? Active ingredient:
• edaravone Inactive ingredients:
• L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured for:
• Piramal Crtical Care, Inc. Bethlehem, PA 18017, USA Issued:
• 09/2023 17 17

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Edaravone injection is supplied for intravenous infusion in a single-dose polypropylene bag containing 30 mg of edaravone in 100 mL of clear, colorless aqueous solution. Injection:
• 30 mg/100 mL in a single-dose polypropylene bag ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• 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 a single-dose polypropylene bags, each overwrapped with clear pouch secondary packaging containing an oxygen absorber and oxygen indicator, which should be pink to reflect appropriate oxygen levels and clear pouch is further overwrapped in PET pouch [see Dosage and Administration (2.2) and How Supplied/Storage and Handling (16.2) ] .
• These are supplied in cartons as listed below.
• NDC 66794-259-61 30 mg/100 mL (0.3 mg/mL) single-dose bag NDC 66794-259-64 2 bags per carton
• 16.2 Storage and Handling Store Edaravone Injection at 20º to 25ºC (68º to 77ºF); excursions permitted from 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
• Protect from light.
• Store in overwrapped package to protect from oxygen degradation until time of use.
• The oxygen indicator will turn blue or purple if the oxygen has exceeded acceptable levels.
• Once the overwrap package is opened, use within 24 hours.

Quoted from the official label, section “How Supplied”.

What is in it

• 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.
• Edaravone injection is supplied for intravenous infusion in a polypropylene bag containing 30 mg edaravone in 100 mL isotonic, sterile, aqueous solution, which is further overwrapped with clear pouch.
• The overwrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation.
• Clear pouch is further overwrapped in PET pouch.
• Each bag 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.
• Edaravone-SPL-Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Edaravone