Edaravone
60 mg/100mL · Injection, Solution
- Prescription only
- Active substance
- Edaravone
- Made by
- XGen Pharmaceuticals DJB, Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
What it is for
This information is not included in the verified source. Open the official leaflet
How it works
From the US prescribing label for the same active substance (RADICAVA ORS). It describes the substance, not this exact product.
The mechanism by which RADICAVA and RADICAVA ORS exert their therapeutic effect in patients with ALS is unknown.
Edaravone is metabolized to a sulfate conjugate and a glucuronide conjugate, which are not pharmacologically active.
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).
Following oral administration of RADICAVA ORS to healthy subjects, the C max decreased by 82%, and the AUC decreased by 61% with a high-fat meal compared to fasted conditions.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-05
Safety of the active substance
From the US prescribing label for the same active substance (RADICAVA ORS). It describes the substance, not this exact product.
- 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 [see Warnings and Precautions (5.1, 5.2) ].
- Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in RADICAVA and/or RADICAVA ORS ( 4 )
Most Common Adverse Reactions Observed During Clinical Studies Table 2 lists the adverse reactions that occurred in ≥2% of patients in the RADICAVA-treated group and that occurred at least 2% more frequently than in the placebo-treated group in randomized placebo-controlled ALS trials.
Quoted from the US prescribing label for the same active substance. Your own pack’s leaflet is the authority for your product. DailyMed
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.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | XGen Pharmaceuticals DJB, Inc. |
|---|---|
| Active substance | Edaravone |
| Strength | 60 mg/100mL |
| Form | Injection, Solution |
| Route | Intravenous |
| Packs | 1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE |
| NDC | 39822-4510 |
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).
Other strengths and forms
5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection, Solution4 products
30 mg/100mL2
30 mg/100mL · 2 companies
60 mg/100mL2
60 mg/100mL · 2 companies
- Gland Pharma Limited
- XGen Pharmaceuticals DJB, Inc. · this page
- Injection1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.