Exservan

Question 1

What is the risk of using EXSERVAN (riluzole) during pregnancy?

Accepted Answer

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.

Question 2

What are the findings from animal studies regarding riluzole use in pregnancy?

Accepted Answer

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.

Question 3

Is there information about riluzole in breast milk and its effects on breastfeeding infants?

Accepted Answer

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.

Question 4

What is known about riluzole's impact on fertility in rats?

Accepted Answer

Oral administration of riluzole in rats led to decreased fertility indices and increased embryolethality.

Question 5

Is EXSERVAN safe and effective for pediatric use?

Accepted Answer

Safety and effectiveness in pediatric patients have not been established for EXSERVAN.

Question 6

How does riluzole perform in elderly patients?

Accepted Answer

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.

Question 7

What should be considered for patients with hepatic impairment when using EXSERVAN?

Accepted Answer

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.

Question 8

What's unique about riluzole use in Japanese patients?

Accepted Answer

Japanese patients might have higher riluzole concentrations, potentially leading to a higher risk of adverse reactions.

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