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Brexanolone Pregnancy and Breastfeeding Warnings

Brexanolone is also known as: Zulresso

Medically reviewed by Drugs.com. Last updated on Aug 1, 2019.

Brexanolone Pregnancy Warnings

Animal studies have revealed evidence of decreased body weight, decreased pup viability, developmental toxicity, female offspring neurobehavioral deficit, lower pup survival, post-implantation loss, reproductive toxicity. There are no controlled data in human pregnancy.

To monitor maternal-fetal outcomes of pregnant women exposed to antidepressant therapy, a National Pregnancy Registry for Antidepressants has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/

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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are no data available on use of this drug in pregnant women to inform of drug-related risks in adverse fetal/maternal outcomes, major birth defects, or miscarriage.

Comments:
-A pregnancy exposure registry is available.
-Widespread apoptotic neurodegeneration in the developing brain of neonatal animal models exposed to this drug during postnatal days 0 to 14 correspond to brain development during the third trimester of human pregnancy.

See references

Brexanolone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The relative infant dose is predicted to be low.

The maximum relative infant dose of this drug was 1% to 2% of the dose given during infusion, and concentrations of the drug in breast milk were less than 10 ng/mL in over 95% of patients (N=12) at 36 hours after the end of infusion.

See references

References for pregnancy information

  1. "Product Information. Zulresso (brexanolone)." Sage Therapeutics, Inc., Cambridge, MA.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Zulresso (brexanolone)." Sage Therapeutics, Inc., Cambridge, MA.

Further information

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

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