In clinical trials, Radicava^™ was shown to slow decline in the loss of physical function in people with ALS. Participants received either Radicava^™ (60 mg) or placebo. The trial was limited to 6 months for ethical considerations, so that people would not receive placebo any longer than necessary. Participants were also allowed to take riluzole, another treatment for ALS, throughout the study.

Physical Function in Daily Activities*

As measured by average total score on the ALS Functional Rating Scale–Revised (ALSFRS-R) after 6 months

The ALS Functional Rating Scale–Revised (ALSFRS-R) is a 48-point scale that assesses loss of physical function. The average rate of decline without treatment is about 1 point per month.

*Learn more about the ALSFRS-R >

The safety profile of Radicava^™ was demonstrated in multiple clinical trials. Participants received either Radicava^™ (60 mg) or placebo for 6 months.

Other common side effects included skin rash (dermatitis), inflammation of the skin (eczema), respiratory failure, respiratory disorder, not enough oxygen (hypoxia), glucose in the urine (glycosuria), and fungal (tinea) infection.

These are not all of the possible side effects of Radicava^™. Call your HCP for medical advice about side effects.

Below are answers to some questions you may have about Radicava^™. Remember that your HCP is the best person to talk to about your medical condition and questions you may have about Radicava^™ and any possible side effects.

What is Radicava^™?

Radicava^™ is a prescription medicine used to treat people with amyotrophic lateral sclerosis (ALS).

Is Radicava^™ right for me?

Radicava^™ is FDA approved for the treatment of ALS. In clinical trials, Radicava^™ was shown to slow decline in the loss of physical function. If you have ALS, talk to your HCP to see if Radicava^™ is right for you.

What should I tell my healthcare provider before receiving Radicava^™?

Before you receive Radicava^™, tell your HCP 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 HCP should decide if you will receive Radicava^™ or breastfeed)

Tell your HCP about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Who should not receive Radicava^™?

Do not receive Radicava^™ if you are allergic to edaravone or any of the ingredients in Radicava^™. See the next question for a complete list of ingredients in Radicava^™.

What are the ingredients in Radicava^™?

Active ingredient: edaravone. Inactive ingredients: L-cysteine hydrochloride hydrate, sodium bisulfite, sodium chloride, phosphoric acid and sodium hydroxide.

Can I receive Radicava^™ if I am pregnant or breastfeeding?

If you are pregnant, it is not known if Radicava^™ will harm your unborn baby. Tell your HCP if you are pregnant or plan to become pregnant.

It is not known if Radicava^™ passes into breastmilk. Tell your HCP if you are breastfeeding or plan to breastfeed. You and your HCP should decide if you will receive Radicava^™ or breastfeed.

How will I receive Radicava^™?

Your HCP will order Radicava^™ for you. Radicava^™ will be given by intravenous (IV) infusion into your vein.

• It takes about 1 hour to receive the full dose of Radicava^™
• Your HCP will tell you how often you will receive Radicava^™
• Your HCP will monitor you closely during your treatment with Radicava^™

To learn more about the infusion process, go here.

Where do I go for my infusions?

Radicava^™ should be administered under the guidance of an HCP at an infusion center, in a doctor's office, in a hospital, or at home. Talk to your HCP and your insurance provider to find out which options are right for you. Searchlight Support^™ can help you find an infusion site of care. To learn more about the services offered by Searchlight Support^™, call 1-844-SRCHLGT (1-844-772-4548) or go here.

How long do I stay on Radicava^™?

You and your HCP will decide how long to stay on Radicava^™.

How will I know if Radicava^™ is working?

Because Radicava^™ does not cure or reverse ALS, you may think that it is not working or you may feel it is not making a difference. It may help to remember that in clinical trials, Radicava^™ was shown to slow decline in the loss of physical function in people with ALS. It is important to continue to receive Radicava^™ as prescribed and talk to your HCP about any concerns you may have.

Can I receive Radicava^™ if I'm taking riluzole or other medications?

Yes. In clinical trials, riluzole (also known as Rilutek^®) was given along with Radicava^™ in more than 90% of patients. Be sure to tell your HCP about all of the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of Radicava^™?

The most common side effects of Radicava^™ include bruising (contusion), problems walking (gait disturbance), and headache.

Radicava^™ may cause serious side effects. These include:

• Hypersensitivity (allergic) reactions. Hypersensitivity reactions have happened in people receiving Radicava^™ and can happen after your infusion is finished.
• 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 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 HCP 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 HCP will monitor you during treatment to watch for signs and symptoms of all of the serious side effects.

These are not all of the possible side effects of Radicava^™. Call your HCP 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 www.fda.gov/medwatch.

Is Radicava^™ covered by my insurance?

Searchlight Support^™ can help you navigate insurance questions. To learn more, call 1-844-SRCHLGT (1-844-772-4548).

The information and advice provided here are general in nature and are not intended to be a substitute for professional medical advice, diagnosis, or treatment. You are strongly encouraged to seek the advice of your doctor or other qualified healthcare provider with any questions regarding a medical condition.