Pronunciation:

ed-a-RAV-one

Brand Names:

• Radicava

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Central Nervous System Agent

Uses of This Medicine:

Edaravone is used to treat patients with amyotrophic lateral sclerosis (ALS), which is also known as Lou Gehrig's disease.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of edaravone in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of edaravone in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, or history of or
• Sulfite allergy, history of—This medicine contains sodium bisulfite which may cause an allergic reaction in patients with these conditions.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine. It is given through a needle placed in a vein.

This medicine should come with a patient information leaflet. Read and follow the information carefully. Ask your doctor if you have any questions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Talk to your nurse or doctor right away if you have very fast or irregular breathing, a very fast or irregular heartbeat, a rash, fainting, hive-like swellings on the skin, or swelling of the eyelids or around the eyes, face, lips, or tongue.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Blistering, crusting, irritation, itching, or reddening of the skin

blue lips, fingernails, or skin

chest pain or tightness

change in walking and balance

clumsiness or unsteadiness

cough

confusion

cracked, dry, scaly skin

difficult or troubled breathing

dizziness

fast heartbeat

hives, itching, rash, or swelling

irregular, fast or slow, or shallow breathing

skin rash, encrusted, scaly and oozing

unusual bruising

weakness

Less common

Sugar in the urine

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Headache

itching in genital or other skin areas

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.