Safety

Learn more about common and serious adverse reactions, the rate of discontinuation, and use in specific populations for RADICAVA® (edaravone).

Adverse Reactions

The most common adverse reactions were contusion, gait disturbance, and headachea

Safety was demonstrated in pooled placebo-controlled trialsb in which 184 patients with ALS were administered RADICAVA® in 24-week treatment cycles.1

aOccurred in ≥10% of RADICAVA® patients and ≥2% more frequently than placebo.

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

  RADICAVA® (n=184) Placebo (n=184)
Contusion 15% 9%
Gait disturbance 13% 9%
Headache 10% 6%
Dermatitis 8% 5%
Eczema 7% 4%
Respiratory failure, respiratory disorder, hypoxia 6% 4%
Glycosuria 4% 2%
Tinea infection 4% 2%

bPooled placebo-controlled trials include 2 additional studies with 231 additional patients, all using the same treatment regimen.1

  • There were no hypersensitivity reactions during the double-blind period in any of the trials1
    • There has been 1 reported hypersensitivity reaction in postmarketing use
  • Discontinuations were not associated with contusion, gait disturbance, or headache in patients treated with RADICAVA®2
medical information chart

The safety profile of RADICAVA® was derived from 300+ patients with ALS in multiple clinical trials.1


Serious Adverse Reactions

RADICAVA® may cause serious adverse reactions (ARs), including1:

  • Hypersensitivity reactions (redness, wheals, and erythema multiform) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea). If hypersensitivity reactions occur, discontinue RADICAVA®, treat per standard of care, and monitor until the condition resolves
  • Sulfite allergic reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people

Patients should be monitored carefully for all serious ARs. For more details, see the full Prescribing Information.

Discontinuations

The RADICAVA® arm had fewer dropouts than the placebo arm

Fewer RADICAVA® patients discontinued during the double-blind period of the pivotal trial.2

Cumulative discontinuations during the double-blind period2,3,c

line chart comparing discontinuations between placebo and RADICAVA® (edaravone) in pivotal trial line chart comparing discontinuations between placebo and RADICAVA® (edaravone) in pivotal trial

cDetermined by summing the discontinuations for successive cycles, expressed as a percent of patients entering in each group.

  RADICAVA® Placebo
Entered (n) 69 68
Completed (n) 67 60
Discontinued (n) 2/69 8/68
Reasons for Discontin­uation
  • Respiratory abnormality (1)

  • Tracheostomy (1)

  • Adverse events (4)

  • Withdrew consent (2)

  • Tracheostomy (1)

  • Investigator decision
    (owing to worsening ALS) (1)

Lack of discontinuations in the RADICAVA® arm does not equate to product efficacy.

Specific Populations

Pharmacokinetics of RADICAVA®

In clinical trials, no differences in pharmacokinetics were found in1:



greater than or equal to 65
Geriatric patients
29% were age 65 and older
blue male symbol next to blue female symbol
Gender
59% were male
blue globe
Japanese and Caucasian Patients

No pharmacokinetic data are available in patients with renal impairment or hepatic impairment.1



Use in geriatric patients

Of the 184 patients who received RADICAVA® in 3 placebo-controlled trials, 53 were 65 years of age and older, including 2 who were 75 years of age and older.1

  • No overall differences in safety or effectiveness were observed between these patients and younger patients
  • Greater sensitivity of some older individuals cannot be ruled out

Nearly 30% of patients were ≥65 years

pie chart with blue part showing patients greater than or equal to 65 years and green part showing less than 65 years

Use in other specific populations1

  • Pregnancy: there are no adequate data on the developmental risk associated with the 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 of RADICAVA® in pediatric patients have not been established
  • Renal impairment: the effect of renal impairment on the pharmacokinetics of RADICAVA® has not been studied
  • Hepatic impairment: the effect of hepatic impairment on the pharmacokinetics of RADICAVA® has not been studied

To learn more, please see the full Prescribing Information.

    References:
  1. RADICAVA Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2018.
  2. Data on file. Mitsubishi Tanabe Pharma America, Inc.
  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;16:505-512.
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Important Safety Information

Hypersensitivity Reactions

Radicava® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in Radicava®. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported. Patients should be monitored carefully for hypersensitivity reactions, and if they occur, discontinue Radicava®, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions

Radicava® contains sodium bisulfite, and 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.

Most Common Adverse Reactions

Most common adverse reactions (at least 10% and greater than placebo) are contusion, gait disturbance, and headache.

Pregnancy

Based on animal data, Radicava® may cause fetal harm.

Geriatric Use

No overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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.

Indication

Radicava® is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Please see full Prescribing Information.

For more information about RADICAVA®, call 1-888-292-0058.