TM Owner Shionogi Inc.
Radicava 30mg/100mL Injection
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Indications & Clinical Uses
- Radicava 30 mg/100 mL is a US brand of edaravone, a free-radical scavenger antioxidant, supplied as a ready-to-infuse intravenous solution and indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults.
- It was approved by the FDA in 2017 (originally Mitsubishi Tanabe Pharma America; the US label is now held by Shionogi Inc. following a 2025 rights transfer) and is administered as a 60 mg intravenous infusion given over 60 minutes once daily, in cycles of 14 daily doses followed by a 14-day drug-free period initially, then 10 doses per 14-day cycle thereafter; it is not self-administered and requires a healthcare provider and IV access for every dose.
- Edaravone is also marketed in Japan under its original brand, Radicut, which in addition to ALS is separately approved there for acute ischaemic stroke -- an indication Radicava does not carry in the US.
- An oral suspension, Radicava ORS, is also available as a non-infused alternative for eligible patients.
Side Effects
- The most common side effects reported with Radicava in clinical trials, affecting 10% or more of patients, are bruising (contusion), difficulty walking (gait disturbance), and headache.
- Radicava's US label carries no boxed warning, but it does contain sodium bisulfite, which can rarely cause serious allergic-type reactions, including anaphylaxis and life-threatening asthma-like breathing problems, particularly in people with sulfite sensitivity; hypersensitivity reactions to edaravone itself, including anaphylaxis, have also been reported and can occur even after earlier infusions were tolerated without a problem.
- Other reported effects include eczema, dermatitis and irritation near the infusion site.
- Because Radicava is given as an intravenous infusion in a clinic or infusion centre, the care team monitors for reactions during and immediately after each dose.
- Tell the team right away about facial, lip or throat swelling, difficulty breathing, wheezing, rash or hives during or after an infusion, since it may need to be stopped and treated urgently.
Precautions & Warnings
- Radicava must not be given to anyone with a known hypersensitivity to edaravone or to any of the product's inactive ingredients, including sodium bisulfite; a sulfite allergy should be discussed with the care team before starting treatment.
- It is for intravenous infusion only, given through a line by a healthcare professional -- it is not given as a rapid bolus and is never self-injected at home.
- No specific dose adjustment for hepatic or renal impairment is described in the label, but general clinical judgement applies.
- Safety in pregnancy and breastfeeding has not been established in controlled human studies; use in pregnancy only if the potential benefit justifies the potential risk, and discuss breastfeeding with the prescriber.
- Radicava has not been studied in children, so its safety and effectiveness in paediatric ALS are unknown.
- Because each infusion takes about an hour and is repeated on a multi-day cycle, patients should plan around clinic visits and discuss driving after a dose if they feel unwell.
Avoid Interactions
- No clinically significant pharmacokinetic drug interactions have been identified for edaravone: concomitant use with CYP3A4 substrates, BCRP substrates and OAT3 substrates produced no meaningful change in exposure to those other medicines in studies.
- Even so, tell the healthcare provider about every prescription and over-the-counter medicine, herbal product and supplement being used, since Radicava is usually given to people with ALS who are also taking riluzole or other ALS therapies, and any new symptom during combined treatment should be reported.
- Anyone with a known sulfite allergy or asthma should mention this before each infusion, because the product's sodium bisulfite content can trigger or worsen allergic and asthma-type reactions.
- There is no specific food or alcohol restriction in the label, but alcohol use should be discussed with the prescriber given the underlying disease.
- Do not mix Radicava with other drugs in the same infusion line without checking compatibility with the pharmacy or care team.
References
- RADICAVA (edaravone injection / RADICAVA ORS) - US Prescribing Information, DailyMed
- Mitsubishi Tanabe Pharma Canada Announces Discontinuation of RADICAVA IV (edaravone) - ALS Society of Canada
- Shionogi Expands Rare Disease Presence with Planned Acquisition of RADICAVA ORS and IV RADICAVA - Shionogi News Release
Frequently Asked Questions
Radicava (edaravone) is an intravenous medicine used to treat amyotrophic lateral sclerosis (ALS) in adults. It's a free-radical scavenger thought to slow the loss of physical function in ALS. In the US it's approved for ALS only; edaravone's Japanese brand, Radicut, also treats acute stroke there.
Radicava is given as a 60 mg intravenous infusion over about 60 minutes, once daily, by a healthcare provider in a clinic or infusion centre. Treatment starts with 14 daily doses, then a 14-day break, followed by 10 doses per 14-day cycle. You do not inject it yourself.
The most common Radicava side effects are bruising, gait problems and headache. It contains sodium bisulfite and can rarely cause serious allergic reactions, including anaphylaxis, even after earlier infusions were tolerated. Seek urgent help for facial or throat swelling, breathing difficulty, wheeze or hives after an infusion.
No major drug interactions have been found with Radicava (edaravone); it doesn't meaningfully change levels of common CYP3A4, BCRP or OAT3 substrate medicines. Still, tell your care team about every medicine and supplement you take, and mention any sulfite or asthma history before each infusion.
Each Radicava dose is a slow intravenous infusion lasting about 60 minutes at a clinic or infusion centre, with staff monitoring you during and after for allergic reactions. Treatment follows repeating cycles: 14 days of daily infusions first, a 14-day break, then 10 infusion days per following 14-day cycle.
Radicava and Radicut are both brand names for edaravone. Radicava is the US brand, approved only for ALS. Radicut is the original Japanese brand, approved for both ALS and acute ischaemic stroke -- an indication Radicava does not carry in the US, so the two are not interchangeable in use.
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