Cenobamate Pregnancy and Breastfeeding Warnings

Brand names: Xcopri

Cenobamate Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and if the benefit outweighs the risk to the fetus

AU TGA pregnancy category: Data not available
US FDA pregnancy category: Not assigned

Risk Summary: Based on animal data, this drug may cause fetal harm. There are no adequate data on the developmental risk associated with use of this drug in pregnant women.

Comments:
-This drug may decrease the efficacy of oral contraceptives, and according to some authorities, treatment is not recommended in women of reproductive potential not using contraception.
-Advise females of childbearing potential that additional or alternative non-hormonal birth control are recommended during therapy, and should continue until 4 weeks after treatment discontinuation.
-If anti-epileptic therapy is abruptly discontinued during pregnancy, it may result in seizures which could be harmful to the mother and the fetus.
-A pregnancy exposure registry is available.

Pregnant rats administered this drug during organogenesis have shown increased embryofetal mortality, decreased fetal weight, neurobehavioral impairment, and reproductive impairment in their offspring at clinically relevant drug exposures. Teratogenic potential could not be fully evaluated because of the high rate of embryofetal deaths. In pregnant rabbits, administration during the period of organogenesis resulted in increased embryofetal mortality at the highest dose tested, which was also associated with maternal toxicity. When administered to pregnant rats throughout pregnancy and lactation, neurobehavioral impairments described as learning and memory deficits and increased auditory startle response was observed in their offspring. At the highest doses, the offspring showed decreased pre-weaning weight gain and adverse effects on reproductive function. There are no controlled data in human pregnancy.

There are risks related to epilepsy and the use of antiepileptic treatments during pregnancy. The prevalence of malformations is 2 to 3 times greater than the rate of approximately 3% in the general population in the offspring of treated women with epilepsy; however, the extent to which the treatment and/or the underlying condition is responsible is unclear.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Cenobamate Breastfeeding Warnings

If this drug is required by a nursing mother, it is not a reason to discontinue breastfeeding; however, until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
-According to some authorities: As a precautionary measure, breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this drug against any potential adverse effects on the breastfed child from this drug or from the underlying maternal condition.
-Monitor infants for excessive drowsiness if exposed to this drug while nursing.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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