Actor portrayals.
Results from a phase 1 pharmacokinetic study in healthy subjects showed equivalent plasma levels with RADICAVA ORS® and RADICAVA®.1,2
91.3%
RADICAVA® IV
(n=63/69)
91.2%
Placebo
(n=62/68)
At randomization3
Deterioration in ALSFRS-R score of 1 to 4 points during 12-week pre-study observation period
Used a defined population based on an analysis of an earlier clinical trial
Identified patients who would be expected to have a sufficient and measurable deterioration over 24 weeks in order to see a treatment effect
bJapan ALS severity classification grades, which were used for the pivotal clinical trial (J19), range from 1 to 5 as follows7:
1. Able to work or perform housework. 2. Independent living but unable to work. 3. Requiring assistance for eating, excretion, or ambulation. 4. Presence of respiratory insufficiency, difficulty in coughing out sputum, or dysphagia. 5. Using a tracheostomy tube, tube feeding, or tracheostomy positive-pressure ventilation.
Physical Function in Daily Activities at 24 Weeks1,3
change in ALSFRS-R scores from baseline vs placebo at 24 weeks1,3
Physical Function in Daily Activities at 24 Weeks1,3
91.3%
RADICAVA® IV
(n=63/69)
91.2%
Placebo
(n=62/68)
In the clinical trial, RADICAVA® was shown to slow the decline of physical function in people with ALS.1
“…the overall distribution shift suggests that the effect of slowing decline…was driven by the majority of patients responding to treatment rather than a response to treatment that was limited to a specific subtype of patient.”9
ALS can progress rapidly.10 Beginning treatment with RADICAVA® ORS can be critical in slowing the loss of physical function.1,3,11
Hear your peers' experiences with RADICAVA® treatment
aPatients who completed the observation period were randomized to RADICAVA® or placebo.3 Return to content
FVC=forced vital capacity.
QD=once daily.
References: 1. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2. Shimizu H, Nishimura Y, Shiide Y, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197. 3. Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512. 4. Takei K, Tsuda K, Takahashi F, et al. Post-hoc analysis of open-label extension period of study MCI186-19 in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):64-70. 5. Data on file. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc. 6. ClinicalTrials.gov. Phase 3 study of MCI-186 for treatment of amyotrophic lateral sclerosis. Accessed January 6, 2022. https://clinicaltrials.gov/ct2/show/NCT01492686 7. Kalin A, Medina-Paraiso E, Ishizaki K, et al. A safety analysis of edaravone (MCI-186) during the first six cycles (24 weeks) of amyotrophic lateral sclerosis (ALS) therapy from the double-blind period in three randomized, placebo-controlled studies. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):71-79. 8. Castrillo-Viguera C, Grasso DL, Simpson E, et al. Clinical significance in the change of decline in ALSFRS-R. Amyotroph Lateral Scler. 2010;11(1-2):178-180. 9. Takei K, Takahashi F, Liu S, et al. Post-hoc analysis of randomised, placebo-controlled, double-blind study (MCI186-19) of edaravone (MCI-186) in amyotrophic lateral sclerosis. Amyotroph Lateral Scler Frontotemporal Degener. 2017;18(suppl 1):49-54. 10. Grad LI, Rouleau GA, Ravits J, et al. Clinical spectrum of amyotrophic lateral sclerosis (ALS). Cold Spring Harb Perspect Med. 2017;7(8):a024117. 11. Leigh PN, Swash M, Iwasaki Y, et al. Amyotrophic lateral sclerosis: a consensus viewpoint on designing and implementing a clinical trial. Amyotroph Lateral Scler Other Motor Neuron Disord. 2004;5(2):84-98. 12. The ALS C.A.R.E. Program. Center for Outcomes Research, University of Massachusetts Medical School. ALS functional rating scale. Accessed January 6, 2022. http://www.outcomes-umassmed.org/ALS/alsscale.aspx
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information.
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred with RADICAVA.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
RADICAVA and RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
The most common adverse reactions (≥10%) reported in RADICAVA-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Based on animal data, RADICAVA and RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).
Please see full Prescribing Information.
RADICAVA, RADICAVA ORS, the RADICAVA logo, and the corporate symbol of Mitsubishi Tanabe Pharma America are registered trademarks, and the RADICAVA ORS logo is a trademark, 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 Healthcare Professionals Only.
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