Edaravone

Edaravone is used to treat amyotrophic lateral sclerosis (ALS).

Edaravone is available under the following different brand names: Radicava.

Dosage Forms and Strengths

Solution for IV Infusion

• 30 mg/100mL in a single-dose polypropylene bag

Dosage Considerations – Should be Given as Follows:

Amyotrophic Lateral Sclerosis

• Indicated for amyotrophic lateral sclerosis (ALS)
• Initial treatment cycle: Administer 60 mg as an intravenous (IV) infusion over 60 minutes once daily for 14 days, followed by a 14-day drug-free period
• Subsequent treatment cycles: Administer 60 mg as an IV infusion once daily over 60 minutes on 10 of 14 days, followed by a 14-day drug-free period

Dosage Modifications

Renal impairment

• No dose adjustment needed
• Not studied, but not expected to significantly affect the systemic drug exposure

Hepatic impairment

• Mild or moderate: No dose adjustment is needed
• Severe: Not studied; no specific dosing recommendation can be provided

Safety and efficacy not established in pediatric patients.

Side effects of Edaravone include:

• Bruising
• Gait disturbance
• Headache
• Dermatitis
• Eczema
• Respiratory failure, respiratory disorder, low blood oxygen (hypoxia)
• Glucose in the urine
• Tinea infection

Postmarketing side effects of edaravone reported include:

• Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Edaravone has no listed severe interactions with other drugs.
• Edaravone has no listed serious interactions with other drugs.
• Edaravone has no listed moderate interactions with other drugs.
• Edaravone has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

• This medication contains edaravone. Do not take Radicava if you are allergic to edaravone or any ingredients contained in this drug.
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to drug or any of its excipients

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Edaravone?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Edaravone?"

Cautions

• Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (hives, decreased blood pressure, and shortness of breath) reported; monitor for hypersensitivity reactions; if hypersensitivity reactions occur, discontinue the drug, treat per standard of care, and monitor until the condition resolves
• Contains sodium bisulfite, which may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people; sulfite sensitivity occurs more often with a history of asthma

Pregnancy and Lactation

• There are no adequate data on the developmental risk associated with the use of edaravone 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. Consult your doctor.
• It is unknown if edaravone is distributed in human breast milk. Edaravone is excreted in the milk of lactating rats. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for edaravone, and any potential adverse effects on the breastfed infant from the drug or the underlying maternal condition.