Amyotrophic Lateral Sclerosis

<section class="Section" data-sectioncode="34089-3"><a name="ID_9ce0e9a2-2d21-4ecb-bd13-5c20a7ecae35"></a><a name="section-8"></a><p></p><h1>11 DESCRIPTION </h1><p class="First">The active ingredient in RADICAVA and RADICAVA ORS 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<span class="Sub">10</span>H<span class="Sub">10</span>N<span class="Sub">2</span>O and the molecular weight is 174.20.</p><p>The chemical structure is:</p><div class="Figure"><a name="id-1519767805"></a><img alt="chemical-structure" src="chemical-structure.jpg"/></div><p>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. </p><p>RADICAVA injection is a clear, colorless liquid provided as a sterile solution.</p><p>RADICAVA 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 polyvinyl alcohol (PVA) secondary packaging. The overwrapped package also contains an oxygen absorber and oxygen indicator to minimize oxidation. 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.</p><p>RADICAVA ORS (edaravone) oral suspension is a white to off-white color, opaque, homogenous suspension containing 105 mg of edaravone per 5 mL of suspension.  </p><p>RADICAVA ORS contains the following inactive ingredients: L-cysteine hydrochloride hydrate, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sorbitol, and xanthan gum. Phosphoric acid and sodium hydroxide are added to adjust to pH 4. </p></section>

RADICAVA

edaravone

Radicava

100 ML edaravone 0.3 MG/ML Injection

100 ML edaravone 0.3 MG/ML Injection [Radicava]

edaravone 21 MG/ML Oral Suspension

edaravone 21 MG/ML Oral Suspension [Radicava]

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Radicava is utilized in treating adults diagnosed with amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease. This condition involves a gradual deterioration of the nerves responsible for muscle movement, leading to muscle atrophy and weakness.

Belonging to the antioxidant class of medications, Radicava operates by alleviating the impact of oxidative stress. This stress is thought to contribute to the degeneration of motor neurons (nerve cells) in individuals affected by ALS. Sustaining the health of these motor neurons might aid in preserving muscle functionality.

Radicava is administered through intravenous infusion, taking approximately 60 minutes. Conversely, Radicava ORS is an oral suspension that can be taken by mouth or via a feeding tube.

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