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Radicava ®(Edaravone)

Prescription Only

Radicava is utilized in treating adults diagnosed with amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease. This condition involves a gradual deterioration...

Dosage & Administration

Administration

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IV or Oral. Learn more.

Dosing

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RADICAVA: The recommended dosage is 60 mg administered IV over 60 minutes. RADICAVA ORS: The recommended dosage is (5 mL) taken orally or via feeding tube in the morning after overnight fasting. No food for 1 hour after administration except water. Learn more.

Latin Shorthand

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For RADICAVA: Rx: 60mg IV over 60 mins. For RADICAVA ORS: Rx: (5mL) PO/FT in AM after overnight fast. No food for 1 hr post-admin except water.. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

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$0. Learn more.

Annual Cap

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$7,500 for Radicava ORS and $20,000 for Radicava IV. Learn more.

Assistance Expiration

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Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

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Most common adverse reactions (at least 10% of patients treated with RADICAVA and greater than placebo) are contusion, gait disturbance, and headache.. Learn more.

Mechanism of Actions (MoA)

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Other Nervous System Drugs. Learn more.

Special Populations

What is the risk associated with RADICAVA or RADICAVA ORS use in pregnant women?

There's inadequate data on the developmental risk in pregnant women. Animal studies show adverse effects in pregnant rats and rabbits, including increased mortality, decreased growth, delayed sexual development, and altered behavior at clinically relevant doses. Most of these effects occurred at doses linked with maternal toxicity.

What are the background risks of birth defects and miscarriage in the general population and in ALS patients?

In the U.S. general population, estimated risks are 2-4% for major birth defects and 15-20% for miscarriage in recognized pregnancies. However, the background risk in ALS patients remains unknown.

What are the findings from animal studies regarding edaravone administration during pregnancy?

In rats, edaravone administration throughout organogenesis resulted in reduced fetal weight and maternal toxicity at all doses tested. In rabbits, embryofetal death occurred at the highest dose, associated with maternal toxicity.

Are there data on edaravone's presence in human milk or its effects on breastfed infants?

There's no data on edaravone in human milk or its effects on breastfed infants. However, it's known that edaravone and its metabolites are excreted in the milk of lactating rats.

Is RADICAVA or RADICAVA ORS considered safe and effective for pediatric patients?

Safety and effectiveness in pediatric patients have not been established for RADICAVA or RADICAVA ORS.

How does RADICAVA perform in geriatric patients, particularly those aged 65 and older?

In clinical trials involving 184 ALS patients receiving RADICAVA, 53 were 65 or older, including 2 patients 75 or older. No overall differences in safety or effectiveness were observed compared to younger patients. However, some older individuals may exhibit greater sensitivity.

®()	Radicava ®(Edaravone)

Prescription Only	Prescription Only Radicava is utilized in treating adults diagnosed with amyotrophic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease. This condition involves a gradual deterioration...
Dosage & Administration	Dosage & Administration comparison data
Administration
Learn more.	IV or Oral. Learn more.
Dosing
Learn more.	RADICAVA: The recommended dosage is 60 mg administered IV over 60 minutes. RADICAVA ORS: The recommended dosage is (5 mL) taken orally or via feeding tube in the morning after overnight fasting. No food for 1 hour after administration except water. Learn more.
Latin Shorthand
Learn more.	For RADICAVA: Rx: 60mg IV over 60 mins. For RADICAVA ORS: Rx: (5mL) PO/FT in AM after overnight fast. No food for 1 hr post-admin except water.. Learn more.
Financial Assistance	Financial Assistance comparison data
Out-Of-Pocket Costs With Copay Card
Learn more.	$0. Learn more.
Annual Cap
Learn more.	$7,500 for Radicava ORS and $20,000 for Radicava IV. Learn more.
Assistance Expiration
Learn more.	Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory	Physician Advisory comparison data
Adverse Reactions
Learn more.	Most common adverse reactions (at least 10% of patients treated with RADICAVA and greater than placebo) are contusion, gait disturbance, and headache.. Learn more.
Mechanism of Actions (MoA)
Learn more.	Other Nervous System Drugs. Learn more.
Special Populations
	What is the risk associated with RADICAVA or RADICAVA ORS use in pregnant women? There's inadequate data on the developmental risk in pregnant women. Animal studies show adverse effects in pregnant rats and rabbits, including increased mortality, decreased growth, delayed sexual development, and altered behavior at clinically relevant doses. Most of these effects occurred at doses linked with maternal toxicity. What are the background risks of birth defects and miscarriage in the general population and in ALS patients? In the U.S. general population, estimated risks are 2-4% for major birth defects and 15-20% for miscarriage in recognized pregnancies. However, the background risk in ALS patients remains unknown. What are the findings from animal studies regarding edaravone administration during pregnancy? In rats, edaravone administration throughout organogenesis resulted in reduced fetal weight and maternal toxicity at all doses tested. In rabbits, embryofetal death occurred at the highest dose, associated with maternal toxicity. Are there data on edaravone's presence in human milk or its effects on breastfed infants? There's no data on edaravone in human milk or its effects on breastfed infants. However, it's known that edaravone and its metabolites are excreted in the milk of lactating rats. Is RADICAVA or RADICAVA ORS considered safe and effective for pediatric patients? Safety and effectiveness in pediatric patients have not been established for RADICAVA or RADICAVA ORS. How does RADICAVA perform in geriatric patients, particularly those aged 65 and older? In clinical trials involving 184 ALS patients receiving RADICAVA, 53 were 65 or older, including 2 patients 75 or older. No overall differences in safety or effectiveness were observed compared to younger patients. However, some older individuals may exhibit greater sensitivity.

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