Compare drug alternatives
|Dosage & Administration
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.
Out-Of-Pocket Costs With Copay Card
No lower-cost generic available
No lower-cost generic available
Most common adverse reactions (incidence greater than or equal to 5% and greater than placebo) were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.. Learn more.
Mechanism of Actions (MoA)
What is the risk of using EXSERVAN (riluzole) during pregnancy?
There are no studies of riluzole in pregnant women, but animal studies suggest potential developmental toxicity at clinically relevant doses. Women should be informed of possible fetal risks associated with using EXSERVAN during pregnancy.
What are the findings from animal studies regarding riluzole use in pregnancy?
Oral administration of riluzole to pregnant rats and rabbits during organogenesis resulted in decreased fetal growth and increased embryofetal mortality at higher doses. Maternal toxicity was observed at the highest doses tested.
Is there information about riluzole in breast milk and its effects on breastfeeding infants?
There's no data on the presence of riluzole in human milk or its effects on breastfed infants. However, riluzole or its metabolites have been detected in the milk of lactating rats. Consideration should be given to breastfeeding benefits alongside potential adverse effects of EXSERVAN on the infant.
What is known about riluzole's impact on fertility in rats?
Oral administration of riluzole in rats led to decreased fertility indices and increased embryolethality.
Is EXSERVAN safe and effective for pediatric use?
Safety and effectiveness in pediatric patients have not been established for EXSERVAN.
How does riluzole perform in elderly patients?
In clinical studies, no significant differences in safety or effectiveness were observed between elderly and younger patients. However, some older individuals might have increased sensitivity.
What should be considered for patients with hepatic impairment when using EXSERVAN?
Patients with mild or moderate hepatic impairment may have increased risk of adverse reactions due to elevated riluzole exposure. EXSERVAN is not recommended for patients with certain baseline elevations in serum aminotransferases or evidence of liver dysfunction.
What's unique about riluzole use in Japanese patients?
Japanese patients might have higher riluzole concentrations, potentially leading to a higher risk of adverse reactions.
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.