Edaravone

What is Edaravone?

• Edaravone (Radicava) used to treat people with Amyotrophic Lateral Sclerosis (ALS).

What are the uses of this medicine?

• This medicine is used for the treatment of amyotrophic lateral sclerosis (ALS).

How does this medicine work?

• The mechanism by which Radicava exerts its therapeutic effect in patients with ALS is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• a history of hypersensitivity to edaravone or any of the inactive ingredients of this product.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Radicava.

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

Recommended Dosageː The recommended dosage is 60 mg administered as an intravenous infusion over 60 minutes as follows:

• Initial treatment cycle: daily dosing for 14 days followed by a 14-day drug-free period
• Subsequent treatment cycles: daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods

Administration

• You will be prescribed Radicava by a healthcare provider.
• Radicava will be given by intravenous (IV) infusion into your vein.
• It takes about 1 hour to receive the full dose of Radicava.
• Your healthcare provider will tell you how often you will receive Radicava.
• Your healthcare provider will monitor you closely during your treatment with Radicava.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 30 mg/100 mL in a single-dose polypropylene bag

This medicine is available in fallowing brand namesː

• Radicava

What side effects can this medication cause?

The most common side effects of this medicine include:

• bruising (contusion)
• problems walking (gait disturbance)
• headache

Radicava may cause serious side effects including:

• Hypersensitivity (allergic) reactions
• Sulfite allergic reactions

What special precautions should I follow?

• Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported with Radicava. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue Radicava, treat per standard of care, and monitor until the condition resolves.
• Radicava contains sodium bisulfite, a sulfite that may cause allergic type reactions, including anaphylactic symptoms and life-threatening.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of Radicava in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness of Radicava in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: edaravone
• Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide.

Who manufactures and distributes this medicine?

• Marketed and distributed by: Mitsubishi Tanabe Pharma America, Inc., a US subsidiary of Mitsubishi Tanabe Pharma Corporation, 525 Washington Blvd., Suite 400, Jersey City, NJ 07310

What should I know about storage and disposal of this medication?

• Store at up to 25°C (77°F).
• Excursions permitted from 15°C to 30°C (59°F to 86°F) .
• Protect from light.
• Store in 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.

• Dailymed label info on Edaravone
• FDA Edaravone

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