Edaravone (Intravenous)

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

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

Your doctor will monitor your progress carefully while you are taking this medicine. This will help your doctor determine if the medicine is effective and check for any side effects.

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

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits it may provide. Consider the following for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also let your health care provider know if you have other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the effects of edaravone in children. Safety and effectiveness have not been established.

Geriatric

So far, studies have not found any geriatric-specific problems that would limit the usefulness of edaravone in older adults.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used together even if an interaction might happen. In such cases, your doctor might want to adjust the dose or take other precautions. Inform your healthcare provider if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare provider about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may influence the use of this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

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

Along with its needed effects, a medicine may cause some unwanted effects. Not all side effects may occur, but if they do, 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. 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.

In the U.S.

• Radicava

Available Dosage Forms:

• Solution

Therapeutic Class: Central Nervous System Agent

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.