Before you receive Radicava® (edaravone), 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.
What are the possible side effects of Radicava®?
- Radicava® may cause serious side effects, including hypersensitivity (allergic)
reactions and sulfite allergic reactions.
- Hypersensitivity reactions have happened in people receiving Radicava® and can
happen after your infusion is finished.
- 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 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; swelling of the lips, tongue, or face; fainting;
breathing problems; wheezing; trouble swallowing; dizziness; itching; or an 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.
These are not all the possible side effects of Radicava®. Call your healthcare
provider for medical advice about side effects. You may report side effects to
Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or
Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
For more information about RADICAVA®, call