FDA

Edaravone

Approved 6 May 2024IntravenousSolution

The FDA lists this product in 10 strengths and forms.

Indications

Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS). Edaravone injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS) ( 1 )

Contraindications

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 )

Warnings and precautions

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 )

5.1Hypersensitivity Reactions

Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have been reported in spontaneous postmarketing reports with edaravone injection. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue edaravone injection, treat per standard of care, and monitor until the condition resolves [see Contraindications (4) ] .

5.2Sulfite Allergic Reactions

Edaravone injection contains sodium bisulfite, a sulfite that 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. Sulfite sensitivity occurs more frequently in asthmatic than non-asthmatic people.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

There are no adequate data on the developmental risk associated with the use of edaravone injection in pregnant women. In animal studies, administration of edaravone to pregnant rats and rabbits resulted in adverse developmental effects (increased mortality, decreased growth, delayed sexual development, and altered behavior) at clinically relevant doses. Most of these effects occurred at doses that were also associated with maternal toxicity (see Animal Data) .

At a glance

Brand name: Edaravone
Route: Intravenous
Dosage form: Solution
Applicant: Gland
Status: Prescription
FDA approval: 6 May 2024
Application: ANDA216199-001

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions

5.2Sulfite Allergic Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

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 Gland Pharma at 609-250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In randomized, placebo-controlled trials, 184 patients with ALS were administered edaravone injection 60 mg in treatment cycles for 6 months. The population consisted of Japanese patients who had a median age of 60 years (range 29 to 75) and were 59% male.

Most (93%) of these patients were living independently at the time of screening. Most Common Adverse Reactions Observed During Clinical Studies Table 2 lists the adverse reactions that occurred in ≥ 2% of patients in the edaravone injection-treated group and that occurred at least 2% more frequently than in the placebo-treated group in randomized placebo-controlled ALS trials. The most common adverse reactions that occurred in ≥ 10% of edaravone injection-treated patients were contusion, gait disturbance, and headache.

Table 2: Adverse Reactions from Pooled Placebo-Controlled Trials a that Occurred in ≥ 2% of Edaravone Injection-Treated Patients and ≥ 2% More Frequently than in Placebo Patients Adverse Reaction Edaravone Injection (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 a Pooled placebo-controlled studies include two additional studies with 231 additional patients, all using the same treatment regimen [see Clinical Studies (14) ].

6.2Postmarketing Experience

The following adverse reactions have been identified during postapproval use of edaravone injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis. [see Warnings and Precautions (5.1 , 5.2 )].

Edaravone

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions

5.2Sulfite Allergic Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Edaravone

Indications

Contraindications

Warnings and precautions

5.1Hypersensitivity Reactions

5.2Sulfite Allergic Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

At a glance

Two medicines in one question?

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information