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Edaravone

Pronunciation

(e DAR a vone)

Index Terms

  • MCI-186

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Radicava: 30 mg/100 mL (100 mL) [contains sodium bisulfite]

Brand Names: U.S.

  • Radicava

Pharmacologic Category

  • Free Radical Scavenger

Pharmacology

The mechanism by which edaravone slows the decline of physical function in patients with ALS is unknown. Edaravone is a free radical and peroxynitrite scavenger that prevents oxidative damage to cell membranes and may contribute to inhibiting the progression of ALS (Nagase 2016).

Metabolism

Metabolized to inactive sulfate and glucuronide conjugates; sulfate conjugate formed by sulfotransferases. Glucuronide conjugation involves UGT1A6, UGT1A9, UGT2B7, and UGT2B17 in the liver and kidney.

Excretion

Urine (70% to 90% as glucuronide conjugate; 5% to 10% as sulfate conjugate; ≤1% unchanged)

Time to Peak

1 hour

Half-Life Elimination

4.5 to 6 hours

Protein Binding

92% (mainly albumin)

Use: Labeled Indications

Amyotrophic lateral sclerosis: Treatment of amyotrophic lateral sclerosis (ALS)

Contraindications

Hypersensitivity to edaravone or any component of the formulation

Dosing: Adult

Amyotrophic lateral sclerosis (ALS): IV:

Initial cycle: 60 mg once daily for 14 days, followed by a 14-day drug-free period.

Subsequent cycles: 60 mg once daily for 10 days within a 14-day period, followed by a 14-day drug-free period.

Dosing: Geriatric

Refer to adult dosing. Use with caution.

Dosing: Renal Impairment

No dosage adjustment necessary. Renal impairment is not expected to affect the exposure to edaravone (has not been studied).

Dosing: Hepatic Impairment

Mild to moderate impairment: No dosage adjustment necessary (has not been studied).

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Administration

For IV use only. Administer as two consecutive 30 mg infusion bags (60 mg total) over 60 minutes (infusion rate: ~1 mg/minute [3.33 mL/minute]). Do not mix edaravone with other medications. Do not use if the oxygen indicator has turned blue or purple before opening. Promptly discontinue with any signs or symptoms consistent with a hypersensitivity reaction.

Storage

Store at ≤25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Once overwrap package is opened, use within 24 hours.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Central nervous system: Abnormal gait (13%)

Hematologic & oncologic: Bruise (15%)

1% to 10%:

Central nervous system: Headache (10%)

Dermatologic: Dermatitis (8%), eczema (7%), tinea (4%)

Endocrine & metabolic: Glycosuria (4%)

Respiratory: Dyspnea (≤6%), hypoxia (≤6%), respiratory failure (≤6%)

<1% (Limited to important or life-threatening): Anaphylaxis, hypersensitivity reaction

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity reactions (eg, redness, wheals, erythema multiforme) and anaphylaxis have been reported. If hypersensitivity occurs, discontinue treatment and monitor.

Dosage form specific issues:

• Sodium bisulfite: May contain sodium bisulfite; use caution in patients with asthma or a sulfite allergy.

Monitoring Parameters

Hypersensitivity reactions

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache or skin irritation. Have patient report immediately to prescriber severe dizziness, passing out, shortness of breath, bruising, difficulty walking, or change in balance (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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