Radicut (Edaravone): Mechanism, Uses, Side Effects and Dosing Guide

Drug Summary

Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disorder that causes motor neuron degeneration, leading to muscle weakness and respiratory failure. Radicut (edaravone) is one of the pharmaceutical compounds approved to slow down the progression of ALS. It is specifically designed to help slow the progression of the disease rather than just manage its symptoms.^1-3

For patients in India, access of Radicut can be arranged through authorised international medicine channels via Named Patient Program, and platforms like Rx4U help simplify the process by connecting patients with trusted access pathways. Read on to find out more about the same.  

Uses and Indications

Since the approval of edaravone for the treatment of ALS in Japan and Korea in 2015 and by the US FDA in 2017, it has been increasingly used in the clinical setting.⁴ Its primary use is to slow the decline in motor function deterioration.³

Clinical trial data have suggested that it can provide a considerable survival benefit. For instance, a Japanese study of 45 ALS patients showed that those treated with edaravone had a median survival of 49 months compared with 25 months in the control group. The drug has also been found to slow the decline in forced vital capacity and thereby preserve lung function. Furthermore, analysis suggests that edaravone may benefit specific patient groups, such as those with more severe disease, longer disease duration or slower progression.⁴

^{How Radicut Works (Mechanism of Action)}

Although its exact mechanism isn’t fully understood, Radicut is believed to be effective due to its powerful antioxidant properties. Oxidative stress is a key pathway and factor in neuronal damage and death that contributes to the progression of ALS.⁴

By acting as an antioxidant that scavenges free radicals, edaravone aims to reduce oxidative stress and neuroinflammation.⁴

By preventing this oxidative damage, edaravone helps hinder the progression of motor function deterioration, thereby potentially reducing the morbidity and mortality rates associated with ALS.⁴ Targeting oxidative stress, apart from managing glutamate levels, is one of the methods currently available for the treatment of ALS.^3,4

^{Dosage and Administration Guidelines}

The recommended dose of Radicut is 60 mg administered via a 60-minute intravenous infusion once daily. The treatment cycle is as follows:¹

Initial cycle: Once daily for 14 days, followed by a 14-day drug-free period.

Subsequent cycles: Once daily for 10 of 14 days, each followed by a 14-day drug-free period.

The infusion rate should be approximately 1 mg (3.33 mL) per minute. A crucial administration guideline is that no other medications be injected or mixed with edaravone in the infusion bag.¹

^{Warnings and Precautions}

Edaravone is contraindicated in patients with known hypersensitivity to the drug or to other ingredients in the product. Since edaravone contains sodium bisulfite, patients must also be monitored for sulfite-related allergic reactions, including anaphylactic symptoms. Sulfite sensitivity is more common among individuals with asthma.¹

Patients should be carefully monitored for signs of hypersensitivity reactions, such as redness and wheals, and symptoms of anaphylaxis, such as urticaria, decreased blood pressure and dyspnea.¹

If hypersensitivity reactions occur, edaravone should be discontinued immediately, and patients should be managed and monitored until the condition resolves.¹

^{Side Effects/Adverse Reactions}

Radicut (edaravone) is generally considered safe, with most side effects being mild and reversible. Its safety profile is notable, as severe adverse effects, death and treatment discontinuation were found to be the same or lesser than with placebo.⁴

The most commonly reported side effects include the following:⁴

• bruising,
• gait disturbances (problems with walking),
• headaches,
• constipation and dysphagia (difficulty swallowing)

Drug Interactions

The manufacturer advises that no other medications be injected or mixed with edaravone in the infusion bag.¹

^{Use in Special Populations}

No additional precautions have been advised for elderly patients. Furthermore, the drug is not contraindicated in individuals with renal or hepatic impairment. However, data on risks during pregnancy or breastfeeding remain unknown.⁴

^{Monitoring and Follow-Up}

Careful monitoring is essential, particularly for hypersensitivity reactions (including sulfite-associated allergic reactions and anaphylaxis) during treatment. If hypersensitivity occurs, treatment must be stopped immediately, and the patient managed symptomatically until the effects wear off.¹

^Toxicity

Repeat dose toxicity studies in dogs and monkeys showed central and peripheral nerve fibre degeneration when edaravone was administered by continuous 24-hour intravenous infusion. Concern about this toxicity is diminished in humans since the drug is not administered by continuous infusion.⁵

 ^FAQs

1. What are the FDA-approved drugs for ALS?

- Edaravone (Radicut), sodium phenylbutyrate/taurursodiol and Riluzole are the FDA-approved drugs for ALS.³

2. What are the common side effects of edaravone?

- Bruising, gait disturbances and headaches are among most commonly reported side effects of edaravone.⁴

3. How is edaravone given?

- It can be taken as an intravenous infusion or oral suspension, usually in 28-day treatment cycles with drug-free breaks.⁴

4. Can I access Radicut in India?

- Yes, Radicut can be accessed through the Named Patient Program, through websites such as rx4u.in.

References

1. Cruz MP. Edaravone (Radicava): a novel neuroprotective agent for the treatment of amyotrophic lateral sclerosis. Pharm & Ther. 2018;43(1):25-28.
2. Brotman RG, Moreno-Escobar MC, Joseph J, et al. Amyotrophic lateral sclerosis. [Updated 2024 Feb 12]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK556151/
3. Tzeplaeff L, Wilfling S, Requardt MV, Herdick M. Current state and future directions in the therapy of ALS. 2023;12(11):1523. doi:10.3390/cells12111523
4. Neupane P, Thada PK, Singh P, et al. Investigating edaravone use for management of amyotrophic lateral sclerosis (ALS): a narrative review. 2023;15(1):e33746. doi:10.7759/cureus.33746.
5. Food and Drug Administration. Pharmacology/Toxicology NDA Review and Evaluation: Application No. 209-176 (Edaravone; RADICAVA™). US Department of Health & Human Services; 2017

Disclaimer:

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Note:

The information provided is for education purpose only and is subjected to prescribing information of the drug and the guidance of your treating physician. Always consult your health care provider before making any medical decision for starting your treatment.