RADICAVA® (Edaravone)

RADICAVA®

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Important Safety Information

RADICAVA® (edaravone) is a prescription infusion medication used to treat amyotrophic lateral sclerosis (ALS). It’s the only FDA-approved medication for ALS. It is not a cure, and it does not restore functions that have already been lost, but it can help slow down the decline of additional physical functions.

Prior to starting treatment, discuss your medical history with your healthcare provider — especially if you have experienced allergic reactions from other medications or if you have asthma. RADICAVA® may interact with other medications. Tell your doctor about all other drugs you’re currently taking — regardless of whether they’re prescription, over-the-counter, vitamins, or herbal supplements.

RADICAVA® will harm an unborn baby. Therefore, tell your doctor if you’re pregnant or if there’s a possibility that you may be pregnant before starting treatment. It is unknown whether the medication could be transferred to your child via breast milk. Talk to your healthcare provider about alternative feeding options for your baby.

What is the most important information I should know about RADICAVA®?

RADICAVA® contains sodium bisulfite, which could cause life-threatening allergic reactions in some individuals. This risk is higher in patients who have asthma. Tell your medical provider immediately if you experience hives, wheezing, breathing difficulties, swelling of the face, lips, and/or tongue, trouble swallowing, and/or itching — as these could be signs of such an allergic reaction.

Side Effects of RADICAVA®

As with any prescription medication, RADICAVA® carries the risk of side effects. The most common ones include:

  • Headaches
  • Walking difficulties
  • Bruising
  • Skin rash
  • Eczema Fungal infections
  • Glucose in the urine

In rare cases, RADICAVA® may cause more serious side effects. Seek emergency medical care if you experience breathing difficulties, as the medication may cause respiratory disorders and/or failure.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

RADICAVA® is used to treat amyotrophic lateral sclerosis (ALS). The recommended dosage is 60 mg over 60 minutes, with variations between the initial dose and subsequent treatment.

Please refer to the full prescribing information.