EDARAVONE

Edaravone injection is administered by IV infusion. The maximum plasma concentration (C max ) of edaravone was reached by the end of infusion. There was a trend of more than dose-proportional increase in area under the concentration-time curve (AUC) and Cmax of edaravone. With multiple-dose administration, edaravone does not accumulate in plasma.

DistributionEdaravone is bound to human serum proteins (92%), mainly to albumin, with no concentration dependence in the range of 0.1 to 50 micromol/L...

The efficacy of edaravone injection for the treatment of ALS was established in a 6-month, randomized, placebo-controlled, double-blind study conducted in Japanese patients with ALS who were living independently and met the following criteria at screening: 1. Functionality retained most activities of daily living (defined as scores of 2 points or better on each individual item of the ALS Functional Rating Scale – Revised [ALSFRS-R; described below]) 2. Normal respiratory function (defined as percent-predicted forced vital capacity values of [%FVC] ≥ 80%) 3. Definite or Probable ALS based on El...

The following serious adverse reactions are described elsewhere in the labeling:

• Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]
• Sulfite Allergic Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (at least 10% of patients treated with edaravone injection and greater than placebo) are contusion, gait disturbance, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Piramal Crtical Care, Inc. at 1-800-414-1901 or FDA at 1-800-FDA-1088...

Edaravone injection is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in this product. Hypersensitivity reactions and anaphylactic reactions have occurred [see Warnings and Precautions (5.1 , 5.2 )]. Patients with a history of hypersensitivity to edaravone or any of the inactive ingredients in edaravone injection ( 4 )

Hypersensitivity Reactions: Advise patients to seek immediate medical care ( 5.1 ) Sulfite Allergic Reactions: Edaravone injection contains sodium bisulfite, which may cause allergic type reactions including anaphylactic symptoms and asthmatic episodes in susceptible people ( 5.2 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postma...