Edaravone: Drug information
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(For additional information see "Edaravone: Patient drug information")

For abbreviations and symbols that may be used in Lexicomp (show table)
Brand Names: US
  • Radicava
Pharmacologic Category
  • Free Radical Scavenger
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).

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]

Generic Equivalent Available (US)

No

Administration

IV: 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.

Use

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

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%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity reaction

Contraindications

Hypersensitivity to edaravone or any component of the formulation

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.

Metabolism/Transport Effects

None known.

Drug Interactions

(For additional information: Launch drug interactions program)

There are no known significant interactions.

Pregnancy Implications

Adverse events were observed in some animal reproduction studies.

Breast-Feeding Considerations

It is not known if edaravone is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Monitoring Parameters

Hypersensitivity reactions

Mechanism of Action

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).

Pharmacodynamics/Kinetics

Protein binding: 92% (mainly albumin)

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.

Half-life elimination: 4.5 to 6 hours

Time to peak: 1 hour

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

Pricing: US

Solution (Radicava Intravenous)

30 mg/100 mL (100 mL): $651.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Aravon (IN);
  • Bi Cun (CN);
  • Edavon (IN);
  • Edvo (IN);
  • Nuravon (IN);
  • Radicut (JP, KR);
  • Yi Da Sheng (CN);
  • Youmin (CN)
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REFERENCES

  1. Nagase M, Yamamoto Y, Miyazaki Y, Yoshino H. Increased oxidative stress in patients with amyotrophic lateral sclerosis and the effect of edaravone administration. Redox Rep. 2016;21(3):104-112. doi: 10.1179/1351000215Y.0000000026. [PubMed 26191780]
  2. Radicava (edaravone) [prescribing information]. Jersey City, NJ: MT Pharma America Inc; May 2017.
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