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Cenobamate Pregnancy and Breastfeeding Warnings

Cenobamate is also known as: Xcopri

Medically reviewed by Drugs.com. Last updated on May 27, 2020.

Cenobamate Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

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

Comments:
-Women of reproductive potential should be advised that this drug may decrease the efficacy of oral contraceptives; additional or alternative non-hormonal birth control are recommended.
-Women taking this drug should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; http://www.aedpregnancyregistry.org/ or 1-888-233-2334

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.

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

Benefit should outweigh risk

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. "Product Information. Xcopri (cenobamate)." SK Life Science, Inc., Paramus, NJ.

References for breastfeeding information

  1. "Product Information. Xcopri (cenobamate)." SK Life Science, Inc., Paramus, NJ.

Further information

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