Radicava

Question 1

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

Accepted Answer

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.

Question 2

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

Accepted Answer

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.

Question 3

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

Accepted Answer

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.

Question 4

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

Accepted Answer

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.

Question 5

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

Accepted Answer

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

Question 6

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

Accepted Answer

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.