Is Brexanolone safe while breastfeeding?
Here is what LactMed, the Drugs and Lactation Database published by the U.S. National Institute of Child Health and Human Development (NICHD), reports about Brexanolone. The text below is quoted from that source — it is not our own verdict.
Summary of use during breastfeeding
Because of the low amounts of brexanolone in milk and low oral bioavailability, brexanolone would not be expected to cause any adverse effects in breastfed infants. If brexanolone is required by the mother, it is not a reason to discontinue breastfeeding. Because excessive sedation or sudden loss of consciousness can occur during brexanolone infusion, it is suggested that patients provide a separate caregiver for any child who is present during the infusion.[1]
Effects on the breastfed infant
Relevant published information was not found as of the revision date.
Effects on milk supply
In a study of 12 healthy women given a 60-hour infusion of brexanolone, there were no reports of effects on milk production according to the manufacturer.
Levels in milk
Brexanolone is the pharmaceutical name for the naturally occurring hormone allopregnanolone. Brexanolone has an oral bioavailability of less than 5% in adults.
Maternal Levels. Twelve healthy women who were less than 6 months postpartum received an intravenous infusion of brexanolone titrated to a maximum of 90 mg/kg per hour then tapered down over 60 hours at various study sites. Breastmilk was collected at random times, but at least every 12 hours, daily for 7 days. Peak milk levels occurred between hours 24 and 48 of the infusion when the maximum dosage was being infused. The average peak allopregnanolone breastmilk level was 125 mcg/L. Milk levels fell below the limit of detection (5 mcg/L) in most women by about 3 days after the end of the infusion. These data were incorporated into a population pharmacokinetic model that predicted that 95% of patients have milk allopregnanolone levels <10 mcg/L at 36 hours after the end of the infusion. The predicted median weight-adjusted percent of maternal dosage was 0.69% and the maximum was 1.3%.[2]
Infant Levels. Relevant published information was not found as of the revision date.
Alternatives LactMed lists
Source: Drugs and Lactation Database (LactMed), National Institute of Child Health and Human Development (NICHD), via NCBI Bookshelf, record “Brexanolone” (LM1472). LactMed on NCBI Bookshelf. LactMed is a registered trademark of the U.S. Department of Health and Human Services.
Educational summary of an authoritative source — not medical advice. Never start, stop, or change a medicine while breastfeeding without confirming with your doctor.