Safety
Learn more about common and serious adverse reactions (side effects), the rate of discontinuation, and use in specific populations for
Adverse Reactions
The most common adverse reactions were contusion, gait disturbance, and headachea
Safety outcomes were derived from pooled placebo-controlled trialsb in which 184 patients with ALS were administered
aOccurred in ≥10% of
Adverse reactions that occurred in ≥2% of patients treated with RADICAVA® and ≥2% more frequently in placebo-treated patients1
| 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
Serious Adverse Reactions
- 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
Cumulative discontinuations during the double-blind period2,3,c
cDetermined by summing the discontinuations for successive cycles, expressed as a percent of patients entering in each group.
| Placebo | ||
|---|---|---|
| Entered (n) | 69 | 68 |
| Completed (n) | 67 | 60 |
| Discontinued (n) | 2/69 | 8/68 |
| Reasons for discontinuation |
|
|
Lack of discontinuations in the
Specific Populations
Pharmacokinetics of RADICAVA®
In clinical trials, no differences in pharmacokinetics were found in1:
29% were age 65 and older
59% were male
Pharmacokinetic data are available in patients with renal impairment or heptic impairment.1 To learn more, please see Prescribing Information.
Use in geriatric patients
Of the 184 patients who received
- 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
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: 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
To learn more, please see the full Prescribing Information.
-
References:
- RADICAVA Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2018.
- Data on file. Mitsubishi Tanabe Pharma America, Inc.
- 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.
