ALS experts share their experiences with RADICAVA^® IV

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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Safety Profile of RADICAVA ORS^® & RADICAVA^® IV

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

Actor portrayals.

RADICAVA ORS^® (edaravone) offers a similar safety profile as the IV formulation.^1,2

The most common adverse reactions in patients treated with RADICAVA^® (edaravone) or RADICAVA ORS^® included contusion, gait disturbance, headache, and fatigue.^{1,a (see footnote)}

Demonstrated Safety and Tolerability Profile of RADICAVA^®1

With RADICAVA^®, the most common adverse reactions were contusion, gait disturbance, and headache^{1, a (see footnote)}

Safety profile was demonstrated in pooled placebo-controlled trials^{b (see footnote)} in which 184 patients with ALS were administered RADICAVA^® (60 mg) in 24-week treatment cycles.¹

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA^® and ≥2% more frequently in placebo-treated patients¹

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^®1
Discontinuations were not associated with contusion, gait disturbance, or headache in patients treated with RADICAVA^®3

The RADICAVA^® arm had fewer dropouts than the placebo arm³

Fewer patients on RADICAVA^® discontinued during the double-blind period of the pivotal trial.³

Cumulative Discontinuations During the Double-Blind Period^{3,4,c (see footnote)}

Line graph of cumulative discontinuations during the double-blind period. Lack of discontinuations in the RADICAVA® (edaravone) arm does not equate to product efficacy.

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

RADICAVA ORS^® Offers a Similar Safety Profile as the IV Formulation^1,2

RADICAVA ORS^® was generally well-tolerated^1,2

In addition to contusion, gait disturbance (13%), and headache (10%) reported with RADICAVA^® (edaravone), fatigue was observed in 7.6% (14/185) of patients receiving RADICAVA ORS^®1

The safety profile of RADICAVA ORS^® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.^1,2

The safety profiles of RADICAVA^® 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, & 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 out¹

RADICAVA ORS^® Has No Known Drug Interactions¹

In clinical trials, RADICAVA^® and RADICAVA ORS^® have been taken with other approved treatments for ALS^2,3
The pharmacokinetics of edaravone are not expected to be significantly affected by inhibitors of cytochrome P450 (CYP) enzymes, UGTs, or major transporters¹

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

The recommended daily sodium intake is <2300 mg.⁷

RADICAVA ORS^® has no flavoring added, but it does contain sorbitol, an ingredient with a mildly sweet taste.^1,8

Use in Specific Populations¹

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^® 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 ethnicities²

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^aOccurred in ≥10% of patients on RADICAVA^® 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.

References: 1. RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022. 2. 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. 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, 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(sup1):49-54. 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. 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. 8. 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^® & RADICAVA^® IV

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

RADICAVA ORS^® (edaravone) offers a similar safety profile as the IV formulation.^1,2

Demonstrated Safety and Tolerability Profile of RADICAVA^®1

With RADICAVA^®, the most common adverse reactions were contusion, gait disturbance, and headache^{1, a (see footnote)}

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA^® and ≥2% more frequently in placebo-treated patients¹

The RADICAVA^® arm had fewer dropouts than the placebo arm³

Cumulative Discontinuations During the Double-Blind Period^{3,4,c (see footnote)}

RADICAVA ORS^® Offers a Similar Safety Profile as the IV Formulation^1,2

RADICAVA ORS^® was generally well-tolerated^1,2

The safety profile of RADICAVA ORS^® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.^1,2

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, & Gender^5,6

RADICAVA ORS^® Has No Known Drug Interactions¹

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.^1,8

Use in Specific Populations¹

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 Radicava.com

Safety Profile of RADICAVA ORS® & RADICAVA® IV

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

RADICAVA ORS® (edaravone) offers a similar safety profile as the IV formulation.1,2

Demonstrated Safety and Tolerability Profile of RADICAVA®1

With RADICAVA®, the most common adverse reactions were contusion, gait disturbance, and headache1, a (see footnote)

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA® and ≥2% more frequently in placebo-treated patients1

The RADICAVA® arm had fewer dropouts than the placebo arm3

Cumulative Discontinuations During the Double-Blind Period3,4,c (see footnote)

RADICAVA ORS® Offers a Similar Safety Profile as the IV Formulation1,2

RADICAVA ORS® was generally well-tolerated1,2

The safety profile of RADICAVA ORS® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.1,2

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, & Gender5,6

RADICAVA ORS® Has No Known Drug Interactions1

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.1,8

Use in Specific Populations1

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 Radicava.com

Safety Profile of RADICAVA ORS^® & RADICAVA^® IV

RADICAVA ORS^® (edaravone) offers a similar safety profile as the IV formulation.^1,2

Demonstrated Safety and Tolerability Profile of RADICAVA^®1

With RADICAVA^®, the most common adverse reactions were contusion, gait disturbance, and headache^{1, a (see footnote)}

Adverse reactions that occurred in ≥2% of patients treated with RADICAVA^® and ≥2% more frequently in placebo-treated patients¹

The RADICAVA^® arm had fewer dropouts than the placebo arm³

Cumulative Discontinuations During the Double-Blind Period^{3,4,c (see footnote)}

RADICAVA ORS^® Offers a Similar Safety Profile as the IV Formulation^1,2

RADICAVA ORS^® was generally well-tolerated^1,2

The safety profile of RADICAVA ORS^® was demonstrated in a 6-month, phase 3, open-label clinical trial in 185 patients.^1,2

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, & Gender^5,6

RADICAVA ORS^® Has No Known Drug Interactions¹

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.^1,8

Use in Specific Populations¹

RADICAVA ORS^® in clinical trials

The multicenter clinical trial for RADICAVA ORS^®