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.
Refer to adult dosing. Use with caution.
No dosage adjustment necessary. Renal impairment is not expected to affect the exposure to edaravone (has not been studied).
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).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Radicava: 30 mg/100 mL (100 mL) [contains sodium bisulfite]
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.
Amyotrophic lateral sclerosis: Treatment of amyotrophic lateral sclerosis (ALS)
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
Hypersensitivity to edaravone or any component of the formulation
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.
There are no known significant interactions.
Adverse events were observed in some animal reproduction studies.
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.
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).
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)
Solution (Radicava Intravenous)
30 mg/100 mL (100 mL): $651.60
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