Edaravone (ed-a-RAV-one)

Treats amyotrophic lateral sclerosis (ALS).

Brand Name(s):

Radicava ORS

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have a history of asthma or sulfite allergy.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Headache
• Problems with balance or walking
• Unusual bruising

If you notice other side effects that you think are caused by this medicine, tell your doctor

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