Radicava ORS (Oral)

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

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

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

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical help. Contact your doctor right away if you experience 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.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. For this medicine, here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know 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.

Pediatric

Studies have not been conducted to determine how age affects the use of edaravone in children. The safety and effectiveness for this group have not been established.

Geriatric

Current studies have not found any specific issues that would limit the use of edaravone in older adults. However, older patients may be more sensitive to the effects of this medicine than younger 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 and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a chance of interaction. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Other medical issues may impact the use of this medicine. Be sure to tell 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 necessary effects, a medicine can cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Blistering, crusting, irritation, itching, or reddening of the skin
• Blue lips, fingernails, or skin
• Confusion
• Difficulty or trouble breathing
• Dizziness
• Fast heartbeat
• Headache
• Irregular, fast or slow, or shallow breathing
• Swelling
• Trouble 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 happen in some patients. If you notice any other effects, consult your healthcare professional.

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

In the U.S.

• Radicava ORS

Available Dosage Forms:

• Suspension

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.