Patient information: uses, side effects, how to take - Edaravone
What is edaravone injection?
Edaravone injection is a prescription medicine used to treat people with amyotrophic lateral sclerosis (ALS).
It is not known if edaravone injection is safe and effective in children.
Do not receive edaravone injection if you are allergic to edaravone or any of the ingredients in edaravone injection. See the end of this leaflet for a complete list of ingredients in edaravone injection.
Before you take edaravone injection, 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 edaravone injection will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if edaravone passes into your breastmilk. You and your healthcare provider should decide if you will receive edaravone injection 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 edaravone injection?
- You will be prescribed edaravone injection by a healthcare provider and told how often you will receive edaravone injection.
- Edaravone injection will be given by intravenous (IV) infusion into your vein.
- It takes about 1 hour to receive the full dose of edaravone injection.
- Your healthcare provider will monitor you closely during your treatment with edaravone injection.
What are the possible side effects of edaravone injection?
Edaravone injection may cause serious side effects including:
- 1. Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving edaravone injection and can happen after your infusion is finished. Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms:
- hives
- breathing problem
- itching
- swelling of the lips, tongue, face
- dizziness
- wheezing
- fainting
- 2. Sulfite allergic reactions. edaravone injection 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 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.
The most common side effects of edaravone injection include bruising (contusion), problems walking (gait disturbance), and headache.
These are not all the possible side effects of edaravone injection. For more information, ask your healthcare
provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to www.fda.gov/medwatch or Sandoz Inc. at 1-800-525-8747.
What are the ingredients in edaravone injection?
Active ingredient: edaravone
Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid, and sodium hydroxide.
Manufactured by InfoRLife SA for Sandoz Inc., Princeton, NJ 08540
- This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 10/2023