Generic name: edaravone [ e-DAR-a-vone ]
Brand names: Radicava, Radicava ORS
Drug class: Miscellaneous central nervous system agents
What is Radicava?
Radicava works by relieving the effects of oxidative stress, which may be related to the death of motor neurons (nerve cells) in people with amyotrophic lateral sclerosis (ALS). Keeping motor neurons healthy may help to preserve muscle function.
Radicava is used to treat amyotrophic lateral sclerosis.
Radicava is an injection that is given by intravenous infusion over 60 minutes. Radicava ORS is an oral suspension that is taken orally by mouth, or via a feeding tube.
Warnings
Radicava can cause serious allergic reactions. Get emergency medical help if you have hives, itching, trouble breathing, swelling in your face or throat, or if you feel light-headed.
Before taking this medicine
You should not be treated with Radicava or Radicava ORS if you are allergic to edaravone.
To make sure Radicava is safe for you, tell your doctor if you have ever had:
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asthma or a sulfite allergy.
It is not known whether Radicava will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether edaravone passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.
How is Radicava given?
Radicava is injected into a vein through an IV. A healthcare provider will give you this injection.
Radicava is usually given in a 28-day treatment cycle. You may need to use the medicine only during the first 2 weeks of each cycle. Your doctor will determine how long to treat you with this medicine.
This medicine must be given slowly and the IV infusion can take at least 60 minutes to complete.
How should I take Radicava ORS?
Radicava ORS is an oral suspension that is taken by mouth or by using a feeding tube.
Always measure your prescribed dose using the oral syringe provided. Ask your healthcare provider or pharmacist if you have any questions about how to measure your prescribed dose.
Follow the Instructions for Use provided with your prescription for detailed information on how to prepare and store Radicava ORS.
Radicava ORS should be taken in the morning on an empty stomach. You should stop eating at bedtime.
- Do not eat or drink anything 8 hours before each dose if you eat a high-fat meal.
- Do not eat or drink anything 4 hours before each dose if you eat a low-fat meal.
- Do not eat or drink anything 2 hours before each dose if you take a calorie supplement.
- You should wait at least 1 hour after taking your medicine before eating or drinking anything except water.
Dosing information
Usual Adult Dose for Amyotrophic Lateral Sclerosis:
Radicava
-Initial Treatment Cycle: 60 mg once a day as IV infusion for 14 days followed by a 14-day drug-free period.
-Subsequent Treatment Cycles: 60 mg once a day as IV infusion for 10 days out of 14-day periods, followed by 14-day drug-free periods.
Comments:
-Administer each 60 mg dose as 2 consecutive 30 mg IV infusion bags over a total of 60 minutes (infusion rate approximately 1 mg per minute [3.33 mL per minute]).
-Upon the first observation of any signs or symptoms of a hypersensitivity reaction, promptly discontinue the infusion.
Use: Treatment of amyotrophic lateral sclerosis (ALS)
Radicava ORS
-Initial Treatment Cycle: 105 mg (5 mL) once a day orally or via feeding tube for 14 days followed by a 14-day drug-free period.
-Subsequent Treatment Cycles: 105 mg (5 mL) once a day orally or via feeding tube for 10 days out of 14-day periods, followed by 14-day drug-free periods.
Comments:
-Dose should be administered in the morning after overnight fasting. Food should not be consumed for 1 hour after administration except water.
Use: Treatment of amyotrophic lateral sclerosis (ALS)
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Radicava injection.
If you miss a dose of Radicava ORS, do not take 2 doses the next day. Do not take a dose of Radicava ORS on days 15 through day 28.
What happens if I overdose?
Since the injection is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if you take too much Radicava ORS.
What should I avoid while receiving Radicava?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Radicava side effects
Radicava and Radicava ORS can cause serious side effects including:
Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving Radicava or taking Radicava ORS and can happen after your medicine has been given. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:
- hives
- breathing problems
- itching
- swelling of the lips, tongue, face
- dizziness
- wheezing
- fainting
Sulfite allergic reactions. Radicava and Radicava ORS contain sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe allergic reactions, for example, asthma episodes, in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:
- hives
- trouble breathing or swallowing
- itching
- swelling of the lips, tongue, face
- dizziness
- asthma attack (in people with asthma)
- wheezing
- fainting
Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects and allergic reactions.
Common Radicava side effects may include:
-
bruising;
-
headache; or
-
trouble walking.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Radicava?
Other drugs may interact with edaravone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
What are the ingredients in Radicava and Radicava ORS?
Active ingredient: edaravone
Radicava Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide.
Radicava ORS Inactive ingredients: L-cysteine hydrochloride hydrate, polyvinyl alcohol, simethicone emulsion, sodium bisulfite, sorbitol, and xanthan gum. Phosphoric acid and sodium hydroxide are added to adjust to pH 4.
Where can I get more information?
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Radicava only for the indication prescribed.
Popular FAQ
What is Radicava used to treat?
Radicava (edravone) injection and Radicava ORS, an oral suspension, are used to treat amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease.
ALS is a progressive neurodegenerative disease, which affects nerve cells in the spinal cord and brain. As the disease progresses and motor neurons die the ability of the brain to control the body is lost, affecting a persons ability to speak, eat, move and breathe.
References
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Drug class: miscellaneous central nervous system agents
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