Watch Leading ALS Experts Present on Radicava

In this video series, a panel of ALS experts discuss the benefits, risks, and appropriate uses of Radicava® (edaravone).

ALS Functional Rating Scale–Revised

Learn about the ALS Functional Rating Scale–Revised (ALSFRS-R), the measure used to evaluate the clinical efficacy of Radicava®.

Pivotal trial in ALS

Review information on the pivotal trial of Radicava® in ALS, including the clinical development program, key inclusion criteria, and baseline patient characteristics.

Efficacy and safety

View primary efficacy endpoint data and safety information from the pivotal trial of Radicava®.

Clinical pharmacology

Learn about the pharmacokinetics, dosing, and administration of Radicava®.

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.