Generic Name: edaravone
Date of Approval: May 5, 2017
Dosage Form: Injection
Company: Mitsubishi Tanabe Pharma
Treatment for: Amyotrophic Lateral Sclerosis
FDA Approves Radicava
The U.S. Food and Drug Administration (FDA) has approved Radicava (edaravone), a free radical scavenger that relieves the effects of oxidative stress, a likely factor in the onset and progression of amyotrophic lateral sclerosis.
Read this Patient Information before you start, and each time you receive treatment. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
What is Radicava?
Radicava is a prescription medicine used to treat people with Amyotrophic Lateral Sclerosis (ALS).
It is not known if this medicine is safe and effective in children.
Do not receive Radicava if you are allergic to edaravone or any of the other ingredients. See the end of this page for a complete list of ingredients.
Before you receive Radicava, tell your healthcare provider about all of your medical conditions, including if you:
- have asthma.
- are allergic to other medicines.
- are pregnant or plan to become pregnant. It is not known if Radicava will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Radicava passes into your breastmilk. You and your healthcare provider should decide if you will receive Radicava or breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Radicava?
- You will be prescribed Radicava by a healthcare provider. The injection will be given by intravenous (IV) infusion into your vein.
- It takes about one hour to receive the full dose.
- Your healthcare provider will tell you how often you will receive Radicava.
- Your healthcare provider will monitor you closely during your treatment.
Radicava side effects
Radicava may cause serious side effects including:
- Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving Radicava and can happen after your infusion is finished. Tell you healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:
- swelling of the lips, tongue, face
- breathing problems
- Sulfite allergic reactions. Radicava contains 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 you healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:
- swelling of the lips, tongue, face
- trouble breathing or swallowing
- asthma attack (in people with asthma)
Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.
The most common side effects include bruising (contusion), problems walking (gait disturbance), and headache.
These are not all the possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to MT Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What are the ingredients in Radicava?
Active ingredient: edaravone
Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid and sodium hydroxide.