edaravone (Rx)

Brand and Other Names:Radicava
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution for IV infusion

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

Amyotrophic Lateral Sclerosis

Indicated for amyotrophic lateral sclerosis (ALS)

Initial treatment cycle: Administer 60 mg as an IV infusion over 60 minutes qDay for 14 days, followed by a 14-day drug-free period

Subsequent treatment cycles: Administer 60 mg as an IV infusion qDay over 60 minutes on 10 of 14 days, followed by a 14-day drug-free period

Also see Administration

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 needed
  • Severe: Not studied; no specific dosing recommendation can be provided

Safety and efficacy not established

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Adverse Effects

>10%

Contusion (15%)

Gait disturbance (13%)

1-10%

Headache (10%)

Dermatitis (8%)

Eczema (7%)

Respiratory failure, respiratory disorder, hypoxia (6%)

Glycosuria (4%)

Tinea infection (4%)

Postmarketing Reports

Skin and subcutaneous tissue disorders: Hypersensitivity reactions and anaphylaxis

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Warnings

Contraindications

Hypersensitivity to drug or any of its excipients

Cautions

Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) reported; monitor for hypersensitivity reactions; if hypersensitivity reactions occur, discontinue drug, treat per standard of care, and monitor until 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 history of asthma

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Pregnancy

Pregnancy

There are no adequate data on the developmental risk associated with use in pregnant women

In animal studies, administration 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

Lactation

Unknown if distributed in human breast milk

Excreted in the milk of lactating rats

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Pyrazolone free radical scavenger; mechanism by which the drug exerts its therapeutic effects in ALS in unknown

Theorized to decrease effects of oxidative stress, a likely factor in the onset and progression of ALS

Absorption

Peak plasma concentration: At end of infusion time

Distribution

Protein bound: 92% (mainly albumin)

Metabolism

Edaravone is metabolized to a sulfate conjugate and a glucuronide conjugate, which are not pharmacologically active

Elimination

Half-life: 4.5-6 hr

Excretion

  • Glucuronide conjugate: 70-90%
  • Sulfate conjugate: 5-10%
  • Unchanged drug: ≤1%
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Administration

IV Preparation

Do not use if the oxygen indicator has turned blue or purple before opening the package

Once the overwrap package is opened, use within 24 hr

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit

Edaravone is a clear, colorless, aqueous solution

Other medications should not be injected/mixed into the infusion bag

IV Administration

For IV infusion only

Administer each 60-mg dose as 2 consecutive 30-mg IV infusion bags over a total of 60 minutes (infusion rate ~1 mg per minute [3.33 mL] per minute)

Discontinue infusion upon the first observation of any signs or symptoms consistent with a hypersensitivity reaction

Storage

Store at up to 25°C (77°F); excursions permitted from 15-30°C (59-86°F)

Protect from light

Supplied in single-dose polypropylene bags, each overwrapped with polyvinyl alcohol (PVA) secondary packaging containing an oxygen absorber and oxygen indicator, which should be pink to reflect appropriate oxygen levels

Store in PVA overwrapped package to protect from oxygen degradation until time of use

The oxygen indicator turns blue or purple if the oxygen has exceeded acceptable levels

Once the overwrap package is opened, use within 24 hr

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Images

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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