ALS experts share their experiences with RADICAVA^®

This video is sponsored by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The speaker is presenting on behalf of, and has received compensation from MTPA.

RADICAVA ORS^® Treatment Initiation Checklist

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RADICAVA ORS^® recognized as a MAJOR CONTRIBUTION TO PATIENT CARE by the FDA.¹ Request a rep visit.

Safety Profile of RADICAVA ORS^®

Learn more about common and serious adverse reactions (side effects), the rate of discontinuation, and use in specific populations.

THE DIFFERENCE IS EXPERIENCE

RADICAVA formulations have had 7+ years on the market since initial FDA approval in 2017^2,3

REVIEW RADICAVA ORS^® CLINICAL HISTORY

Demonstrated Safety and Tolerability Profile²

With RADICAVA^® IV, the most common adverse reactions were contusion, gait disturbance, and headache^{2, a (see footnote)}

Safety profile was demonstrated in pooled placebo-controlled trials^{b (see footnote)} in which 184 patients with ALS were administered RADICAVA^® IV (60 mg) in 24-week treatment cycles.²

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA^® IV and ≥2% more frequently in placebo-treated patients²

Adverse reactions that occurred in patients treated with RADICAVA® (edaravone) and in placebo-treated patients.

Hypersensitivity reactions and cases of anaphylaxis have been reported in postmarketing reports with RADICAVA^® IV²
Discontinuations were not associated with contusion, gait disturbance, or headache in patients treated with RADICAVA^® IV⁴

The safety profile of RADICAVA ORS^® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.^2,3

In addition to contusion (15%), gait disturbance (13%), and headache (10%) reported with RADICAVA^® IV, fatigue was observed in 7.6% (14/185) of patients receiving RADICAVA ORS^®²

The safety profiles of RADICAVA^® IV and RADICAVA ORS^® were derived from 500+ patients with ALS in multiple clinical trials¹

Only 4 patients discontinued treatment in the first 2 months (4/185).⁵

5.9% (11/185) of patients discontinued RADICAVA ORS^® due to AEs during the phase 3 clinical trial⁵
1.1% (2/185) of patients discontinued RADICAVA ORS^® due to GI-related AEs including diarrhea (0.5%, 1/185) and dysphagia (0.5%, 1/185)⁵
- Other reasons for discontinuation in ≥1% of patients included respiratory failure 1.1% (2/185) of patients and muscular weakness in 1.1% (2/185) of patients

Differences in discontinuations do not represent differences in efficacy or safety.

The Safety Profile of RADICAVA ORS^® Was Generally Consistent Across Age, Race, and Gender^5,6

No overall differences in safety or effectiveness of RADICAVA ORS^® were observed between geriatric patients over the age of 65 and younger patients, but greater sensitivity of some older individuals cannot be ruled out²

RADICAVA ORS^® Has No Known Drug Interactions²

In clinical trials, RADICAVA^® and RADICAVA ORS^® have been taken with other approved treatments for ALS^4,7
The pharmacokinetics of edaravone are not expected to be significantly affected by inhibitors of cytochrome P450 (CYP) enzymes, UGTs, or major transporters²

RADICAVA ORS^® contains 1.1 mg of sodium per dose.⁵

The recommended daily sodium intake is <2300 mg.⁸

RADICAVA ORS^® has no flavoring added, but it does contain sorbitol, an ingredient with a mildly sweet taste.^2,9

Use in Specific Populations²

RADICAVA ORS^® in clinical trials

Pharmacokinetics: There were no significant differences in pharmacokinetics among subjects based on race, age, or gender
Pregnancy: There are no adequate data on the developmental risk associated with use of RADICAVA^® IV in pregnant women
Lactation: There are no data on the presence of edaravone in human milk, the effects on the breastfed infant, or the effects of the drug on milk production
Pediatric: Safety and effectiveness in pediatric patients have not been established
Renal impairment: No dosage adjustments are necessary in patients with mild to moderate renal impairment. The effects of severe renal impairment on the pharmacokinetics of edaravone have not been studied
Hepatic impairment: No dosage adjustments are necessary in patients with hepatic impairment

The multicenter clinical trial for RADICAVA ORS^®

included male and female patients (aged 18-75) in the United States, Canada, France, Germany, Italy, and Japan, and included people of various ethnicities⁷

RADICAVA ORS^® - the ONLY FDA-approved oral form of edaravone - was built on years of clinical research and development

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^aOccurred in ≥10% of patients on RADICAVA^® IV and ≥2% more frequently than placebo. Return to content

^bPooled placebo-controlled trials included 2 additional studies with 231 additional patients, all using the same treatment regimen.¹ Return to content

^cDetermined by summing the discontinuations for successive cycles, expressed as a percent of patients entering each group. Return to content

AE=adverse event; GI=gastrointestinal; UGT=uridine diphosphate glucuronosyltransferase.

References: 1. US Food and Drug Administration. Clinical superiority findings. Accessed April 11, 2024. https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/clinical-superiority-findings 2. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 3. US Food and Drug Administration. FDA approves oral form for the treatment of adults with amyotrophic lateral sclerosis (ALS). Accessed April 11, 2024. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oral-form-treatment-adults-amyotrophic-lateral-sclerosis-als 4. 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. 5. Data on file. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc. 6. Shimizu H, Nishimura Y, Shiide Y, et al. Evaluation of pharmacokinetics, safety, and drug-drug interactions of an oral suspension of edaravone in healthy adults. Clin Pharmacol Drug Dev. 2021;10(10):1174-1187. 7. Genge A, Pattee GL, Sobue G, et al. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023;67(2):124-129. 8. US Department of Agriculture and US Department of Health and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th ed. 2020. Accessed November 8, 2022. https://www.dietaryguidelines.gov. 9. National Center for Biotechnology Information. PubChem compound summary for CID 5780, sorbitol. Accessed November 8, 2022. https://pubchem.ncbi.nlm.nih.gov/compound/Sorbitol

Safety Profile of RADICAVA ORS^®

Demonstrated Safety and Tolerability Profile²

With RADICAVA^® IV, the most common adverse reactions were contusion, gait disturbance, and headache^{2, a (see footnote)}

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA^® IV and ≥2% more frequently in placebo-treated patients²

The safety profile of RADICAVA ORS^® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.^2,3

Only 4 patients discontinued treatment in the first 2 months (4/185).⁵

The Safety Profile of RADICAVA ORS^® Was Generally Consistent Across Age, Race, and Gender^5,6

RADICAVA ORS^® Has No Known Drug Interactions²

RADICAVA ORS^® contains 1.1 mg of sodium per dose.⁵

RADICAVA ORS^® has no flavoring added, but it does contain sorbitol, an ingredient with a mildly sweet taste.^2,9

Use in Specific Populations²

RADICAVA ORS^® in clinical trials

The multicenter clinical trial for RADICAVA ORS^®

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions

Sulfite Allergic Reactions

Adverse Reactions

Pregnancy

INDICATION

You are now leaving RADICAVAHCP.com

Safety Profile of RADICAVA ORS®

Demonstrated Safety and Tolerability Profile2

With RADICAVA® IV, the most common adverse reactions were contusion, gait disturbance, and headache2, a (see footnote)

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA® IV and ≥2% more frequently in placebo-treated patients2

The safety profile of RADICAVA ORS® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.2,3

Only 4 patients discontinued treatment in the first 2 months (4/185).5

The Safety Profile of RADICAVA ORS® Was Generally Consistent Across Age, Race, and Gender5,6

RADICAVA ORS® Has No Known Drug Interactions2

RADICAVA ORS® contains 1.1 mg of sodium per dose.5

RADICAVA ORS® has no flavoring added, but it does contain sorbitol, an ingredient with a mildly sweet taste.2,9

Use in Specific Populations2

RADICAVA ORS® in clinical trials

The multicenter clinical trial for RADICAVA ORS®

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions

Sulfite Allergic Reactions

Adverse Reactions

Pregnancy

INDICATION

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions

Sulfite Allergic Reactions

Adverse Reactions

Pregnancy

INDICATION

You are now leaving RADICAVAHCP.com

Safety Profile of RADICAVA ORS^®

Demonstrated Safety and Tolerability Profile²

With RADICAVA^® IV, the most common adverse reactions were contusion, gait disturbance, and headache^{2, a (see footnote)}

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA^® IV and ≥2% more frequently in placebo-treated patients²

The safety profile of RADICAVA ORS^® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.^2,3

Only 4 patients discontinued treatment in the first 2 months (4/185).⁵

The Safety Profile of RADICAVA ORS^® Was Generally Consistent Across Age, Race, and Gender^5,6

RADICAVA ORS^® Has No Known Drug Interactions²

RADICAVA ORS^® contains 1.1 mg of sodium per dose.⁵

RADICAVA ORS^® has no flavoring added, but it does contain sorbitol, an ingredient with a mildly sweet taste.^2,9

Use in Specific Populations²

RADICAVA ORS^® in clinical trials

The multicenter clinical trial for RADICAVA ORS^®