Nuravon (Edaravone) 1.5mg/ml 20ml Ampoule

Nuravon general information

What is Nuravon used for?

Nuravon injection is used to treat amyotrophic lateral sclerosis (ALS), a rapidly progressive, fatal, neurodegenerative disease that belongs to a wider group of disorders known as motor neuron diseases.  ALS attacks the motor neurons (nerve cells) controlling voluntary muscle action and although not much is known about the pathogenesis of this disease, oxidative stress is known to play an important role.  All muscles in the body become affected including muscles that control breathing which then require ventilation for breathing support.  Survival is usually only 3 to 5 years from the onset of symptoms.  Nuravon injection helps slow progression of the disease and extends life expectancy; however, it does not cure the disease.

How does Nuravon work?

Nuravon injection contains edaravone, a neuroprotective drug with potent antioxidant properties that is used to treat amyotrophic lateral sclerosis (ALS).  Edaravone in Nuravon injection was originally developed as an intravenous treatment of acute ischemic stroke and used to help recovery following a stroke¹.  Further studies indicated a potential benefit in various neurologic diseases, based on its ability to act as a free radical scavenger, which could potentially reduce oxidative stress, which is thought to contribute to neuronal degeneration and cell death in ALS^{2, 3}.  Oxidative stress is the imbalance between the cellular damage caused by free radicals and the body’s ability to detoxify them and prevent their damaging effects on proteins, lipids, and DNA⁴.  Nitrotyrosine is a chemical marker of cell damage, inflammation and oxidative stress caused by free radicles.  Reduced levels of nitrotyrosine were found in cerebrospinal fluid following treatment with intravenous edaravone, which correlated with improved scores on a functional ratings scale to evaluate motor function, and reduced the decline in motor function controlling speech, swallowing and breathing^{5, 6, 7}.  On the basis of clinical studies edaravone was approved by the FDA for treatment of ALS⁸. 

What does Nuravon contain?

Nuravon injection contains the active ingredient edaravone, a neuroprotective drug that is used to treat amyotrophic lateral sclerosis (ALS).

Treating amyotrophic lateral sclerosis (ALS) with Nuravon

Nuravon injection contains edaravone, a neuroprotective drug that is used to treat amyotrophic lateral sclerosis (ALS), a rapidly progressive, fatal, neurodegenerative disease caused by degeneration and cell death of the motor neurons (nerve cells) controlling voluntary muscle action.  Eventually all muscles in the body become affected including muscles that control breathing, which then require ventilation for breathing support.  Oxidative stress is thought to be a key component in the pathogenesis of ALS.  Edaravone in Nuravon injection is a potent antioxidant and is thought to work as a free radical scavenger in the central nervous system.  Clinical studies have shown that edaravone reduces oxidative stress and improves scores on functional ratings scale to evaluate motor function, indicating that edaravone in Nuravon injection helps slow progression of the disease and extends life expectancy.  However, Nuravon injection does not cure the disease.  

What are the side effects of Nuravon?

The most commonly reported side effects when taking Nuravon include contusion (bruising), gait disturbance (problems walking), and headache.

When should Nuravon not be used?

You should not use Nuravon if you:

• are allergic to edaravone or any ingredients in Nuravon
• are pregnant or are breastfeeding

How should Nuravon be taken?

Nuravon injection should be administered as an intravenous infusion of 60 mg administered over a 60-minute period, with an initial treatment cycle of 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.  You should continue to take your Nuravon injection for as long as recommended by your doctor.

How long should you take Nuravon?

You should continue to take your Nuravon injection for as long as recommended by your doctor.

How should Nuravon be stored?

You should store your Nuravon below 25°C in a cool dry place and protect from light.  Store in the 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.

References

1. Miyaji Y, Yoshimura S, Sakai N, Yamagami H, Egashira Y et al. Effect of edaravone on favorable outcome in patients with acute cerebral large vessel occlusion: subanalysis of RESCUE-Japan Registry. Neurol Med Chir (Tokyo) 2015;55(3):241-7.
2. Kikuchi K, KawaharaK-I, Uchikado H, Miyagi N, Terukazu Kuramoto T, et al. Potential of edaravone for neuroprotection in neurologic diseases that do not involve cerebral infarction (Review) Experimental and Therapeutic Medicine 2: 771-775, 2011.
3. Hardiman O, van den Berg LH. Edaravone: a new treatment for ALS on the horizon? Lancet Neurol. 2017 Jul;16(7):490-491.
4. Ahmadinejad F, Geir Møller S, Hashemzadeh-Chaleshtori M, Bidkhori G, Jami MS. Molecular Mechanisms behind Free Radical Scavengers Function against Oxidative Stress. Antioxidants (Basel). 2017 Jul 10;6(3). pii: E51.
5. Nagase M, Yamamoto Y, Miyazaki Y, Yoshino H. Increased oxidative stress in patients with amyotrophic lateral sclerosis and the effect of edaravone administration. Redox Rep 2016 May;21(3):104-12.
6. Yoshino H, Kimura A. Investigation of the therapeutic effects of edaravone, a free radical scavenger, on amyotrophic lateral sclerosis (Phase II study).  Amyotroph Lateral Scler 2006; 7: 241–5
7. Sawada H. Clinical efficacy of edaravone for the treatment of amyotrophic lateral sclerosis. Expert Opin Pharmacother 2017 May;18(7):735-738.
8. Traynor K. FDA approves edaravone for amyotrophic lateral sclerosis. Am J Health Syst Pharm 2017 Jun 15;74(12):868