FDA recognizes RADICAVA ORS® as MAJOR CONTRIBUTION TO PATIENT CARE Call a JourneyMate Resource Specialist at 1-855-457-6968.
FDA recognizes RADICAVA ORS® as MAJOR CONTRIBUTION TO PATIENT CARE Call a JourneyMate Resource Specialist at 1-855-457-6968.
RADICAVA ORS® (edaravone) is an ORAL administration option of RADICAVA® (edaravone), an ALS treatment shown to slow the loss of physical function.
RADICAVA® has been shown to result in 33% less decline in physical function vs placebo as measured by the ALSFRS-R.
RADICAVA ORS® 5 mL dose may take only a few minutes to administer on treatment days.c,d (see footnote)
Review steps about starting RADICAVA®. Learn about financial support options.
RADICAVA ORS® was recognized by the FDA in 2024 for its major contribution to patient care.
RADICAVA ORS® is supported by a foundation of clinical and real-world experience.
SEE THE FULL STORY
No matter where you are in your ALS journey—from diagnosis to treatment—the JourneyMate Support Program™ gives you the understanding, answers, and resources to help you move forward.
If you’re new to treatment, the program can help you learn more about RADICAVA®. If you’re currently using RADICAVA® IV, the program can help you learn more about switching to RADICAVA ORS®.
Join our community of 18,000+ people who’ve signed up to learn more about RADICAVA ORS® or RADICAVA® IV and why it matters to patients and caregivers.
Help other people living with ALS by sharing your experience with ALS and RADICAVA®. See how you can share
ALS=amyotrophic lateral sclerosis; IV=intravenous.
aBased on RADICAVA ORS® and RADICAVA® IV prescriptions submitted in the US as of August 2024. Not independently verified. Return to content
bDays of therapy based on number of RADICAVA ORS® and RADICAVA® IV cartons sold as of August 2024. Each carton of RADICAVA® IV includes 1 day of therapy. For RADICAVA ORS®, each Starter Kit includes 14 days of therapy, and each Maintenance Kit includes 10 days of therapy. Return to content
cThe initial treatment cycle starts with daily dosing of RADICAVA ORS® for 14 days followed by a 14-day drug-free period. Subsequent treatment cycles include daily dosing 10 out of 14 days followed by a 14-day drug-free period. Return to content
dUse the provided 5 mL syringe that comes with the product. Do not use a household teaspoon to measure your medication. Return to content
Do not receive RADICAVA (edaravone) or RADICAVA ORS (edaravone) if you are allergic to edaravone or any of the ingredients in RADICAVA and RADICAVA ORS.
Before you take RADICAVA or RADICAVA ORS, 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 or RADICAVA ORS will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if RADICAVA or RADICAVA ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA or RADICAVA ORS 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 and RADICAVA ORS?
RADICAVA and RADICAVA ORS may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Hypersensitivity reactions have happened in people receiving RADICAVA or taking RADICAVA ORS and can happen after your medicine has been given.
RADICAVA and RADICAVA ORS contain 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 and allergic reactions.
The most common side effects include bruising (contusion), problems walking (gait disturbance) and headache.
These are not all the possible side effects of RADICAVA or RADICAVA ORS. 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 Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058.
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information and Patient Information.
Do not receive RADICAVA (edaravone) or RADICAVA ORS (edaravone) if you are allergic to edaravone or any of the ingredients in RADICAVA and RADICAVA ORS.
Before you take RADICAVA or RADICAVA ORS, 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 or RADICAVA ORS will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if RADICAVA or RADICAVA ORS passes into your breastmilk. You and your healthcare provider should decide if you will receive RADICAVA or RADICAVA ORS 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 and RADICAVA ORS?
RADICAVA and RADICAVA ORS may cause serious side effects, including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Hypersensitivity reactions have happened in people receiving RADICAVA or taking RADICAVA ORS and can happen after your medicine has been given.
RADICAVA and RADICAVA ORS contain 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 and allergic reactions.
The most common side effects include bruising (contusion), problems walking (gait disturbance) and headache.
These are not all the possible side effects of RADICAVA or RADICAVA ORS. 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 Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058.
INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information and Patient Information.
RADICAVA, RADICAVA ORS, the RADICAVA logo, the RADICAVA ORS logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks of Mitsubishi Tanabe Pharma Corporation.
JourneyMate Support Program is a trademark of Mitsubishi Tanabe Pharma America, Inc.
All other company names, product names, trade/service marks or other trade names are the property of their respective owners.
For US audiences only.
© 2024 Mitsubishi Tanabe Pharma America, Inc. All rights reserved. CP-OE-US-0871 10/24
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