RADICAVA ORS® has been evaluated in several medical studies
RADICAVA ORS® can be taken orally or via feeding tube, without the need for dose adjustment
5 mL dose may take only a few minutes to administer on treatment daysb,c (see footnote)
RADICAVA ORS® should be taken in the morning on an empty stomach. You should stop eating at bedtime
RADICAVA ORS® & RADICAVA® IV?
RADICAVA ORS® (edaravone) is an ORAL administration option of RADICAVA® (edaravone), an ALS treatment shown to slow the loss of physical function.
Have questions as you learn about RADICAVA®?
Call a JourneyMate Resource Specialist at 1-855-457-6968 between 9 AM and 9 PM ET, Monday through Friday.
RADICAVA ORS® Is Formulated to Fit Your Life's Routines
Prioritizing the needs of those with ALS
Building on the legacy of RADICAVA®, Mitsubishi Tanabe Pharma America is prioritizing helping people with ALS by continuing to invest in research with edaravone to help meet the needs of the ALS community.
Edaravone has been studied for over a decade in research and development.
Wide experience with RADICAVA®
RADICAVA® has been used to treat 8000+ patients with approximately 1.1 million+ days of therapy since approved by the FDA.a,d (see footnote)
RADICAVA® has been prescribed by nearly 2000 healthcare providers.a (see footnote)
ALS can progress rapidly. Beginning treatment with RADICAVA ORS® or RADICAVA® IV can be important in slowing the loss of physical function.
RADICAVA ORS® is an oral administration option of RADICAVA (edaravone)
RADICAVA® has been shown to slow the loss of physical function by 33% (approximately one-third) vs placebo.
Slowed loss of physical function at 24 weeks
Patients lost fewer points on the ALSFRS-R
In the pivotal study, RADICAVA® slowed the loss of physical function as measured by the ALSFRS-R. At 24 weeks (about 6 months), patients who did not receive RADICAVA® declined more rapidly in physical function, having lost an average of 2.49 points more than those who received RADICAVA®.
Individual results may vary.
Patients taking RADICAVA® lost fewer points at 24 weeks as measured by the ALSFRS-R.
3X as many patients given RADICAVA® lost 2 or less points
(39.1% RADICAVA® vs 13.2% placebo)
A similar number of patients in both treatment arms lost 3 to 10 points (37/69 with RADICAVA® and 43/68 with placebo).
3X as many patients given placebo lost 11 or less points
(23.5% placebo vs 7.2% RADICAVA®)
Over 90% of patients in each group were also being treated with riluzole.
Understanding the Safety Profile of RADICAVA ORS® and RADICAVA® IV
RADICAVA ORS® has a similar safety profile as the IV formulation of RADICAVA® (edaravone).
The safety profile of RADICAVA® and RADICAVA ORS® was established in 500+ patients with ALS in multiple clinical studies.
Side effect profile:
The safety of the IV formulation of RADICAVA® was evaluated in multiple placebo-controlled studies in 184 patients with ALS.
The safety of RADICAVA ORS® was demonstrated in a 24-week clinical study of 185 patients with ALS.
The most common side effects were bruising (contusion) [15%], problems with walking (gait disturbance) [13%], and headache [10%]. Fatigue was also reported in 7.6% of patients taking RADICAVA ORS®.
These are not all of the possible side effects with RADICAVA® or RADICAVA ORS®.
RADICAVA ORS® and RADICAVA® IV have no known drug interactions
Fewer than 6% of patients discontinued RADICAVA ORS® because of side effects in the 24-week safety study in 185 patients with ALS
Approximately 1% of patients discontinued RADICAVA ORS® due to gastrointestinal side effects (diarrhea and trouble swallowing)
The Prescribing Information has no requirement for monitoring kidney or liver function.
RADICAVA® and RADICAVA ORS® may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Make sure to tell your doctor:
If you have asthma
If you are allergic to other medications
If you are pregnant or intend to become pregnant
If you are breastfeeding or intend to breastfeed
All of the medications you are taking
Please see additional Important Safety Information.
Understanding Your Treatment With RADICAVA ORS®
Watch this video to learn more about this oral ALS treatment option.
Get answers to FAQs about RADICAVA ORS® and RADICAVA® IV.
aBased on RADICAVA ORS® and RADICAVA® IV prescriptions submitted in the US as of September 2022. Not independently verified. Return to content
bThe 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
cUse the provided 5 mL syringe that comes with the product. Do not use a household teaspoon to measure your medication. Return to content
dDays of therapy based on number of RADICAVA ORS® and RADICAVA® IV cartons sold as of September 2022. Each carton represents a day’s supply of therapy. Return to content
FDA=Food and Drug Administration; IV=intravenous.