Pronunciation:

ed-a-RAV-one

Brand Names:

• Radicava ORS

Dosage Forms:

• Suspension

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. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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

Take this medicine in the morning on an empty stomach. Do not eat or drink anything at bedtime for at least 8 hours if you eat a high-fat meal, 4 hours if a low-fat meal, or 2 hours if you take a calorie supplement.

Do not eat or drink anything except water for 1 hour after taking this medicine.

To use:

• This medicine can be taken by the mouth or be given through nasogastric or PEG tubes.
• Shake the bottle well for at least 30 seconds until no small pieces at the bottom before each use.
• Measure the oral liquid medicine with the provided oral dosing syringe. The average household teaspoon may not hold the right amount of liquid.
• Place the tip of the oral syringe in the mouth towards inside of the cheek. Swallow all the medicine. You may also use 8 ounces or 1 cup of water to help you swallow the medicine.
• If it is given through a feeding tube: Using a catheter-tip syringe, rinse the feeding tube with 30 milliliters (mL) of water. Then, inject the oral syringe with medicine into the feeding tube and rinse the tube with 30 mL water.

If you are receiving the injection form of this medicine, your doctor may switch you to the oral liquid form. Ask your doctor if you have questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (suspension):
  • For amyotrophic lateral sclerosis (ALS):
    • Adults—
      • First treatment cycle—105 milligrams (mg) or 5 milliliters (mL) once a day in the morning for 14 days, followed by 14 days without the medicine.
      • For cycles after the first treatment cycle—105 mg or 5 mL once a day in the morning for 10 days, followed by 14 days without the medicine.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused liquid after 15 days of opening the bottle or 30 days from the date of shipment on the carton label, whichever comes first.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are using 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 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 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

confusion

difficult or trouble breathing

dizziness

fast heartbeat

headache

irregular, fast or slow, or shallow breathing

swelling

trouble in walking

unusual bruising

weakness

Less common

Itching in the genital or other skin areas

scaling

sugar in the urine

Incidence not known

Chest tightness

cough

difficulty swallowing

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

skin itching, rash, or redness

swelling of the face, throat, or tongue

unusual tiredness or weakness

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.