Brexanolone Pregnancy and Breastfeeding Warnings

Brand names: Zulresso

Medically reviewed by Drugs.com. Last updated on Jul 22, 2024.

Brexanolone Pregnancy Warnings

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.

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.

See references

Brexanolone Breastfeeding Warnings

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes

Comments:
- This drug would not be expected to cause any adverse events in breastfed infants, due to the low amounts in milk and low oral bioavailability.
-If treatment with this drug is required by the mother, there is no reason to discontinue breastfeeding.
-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

Further information

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

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