Summary of Use during Lactation

No published information is available on the clinical use of ganaxolone during breastfeeding. However, a study by the manufacturer indicates that amounts in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants.

Drug Levels

Maternal Levels. The manufacturer reports that a study was conducted in 5 healthy adult lactating women treated with a single 300 mg oral dose of ganaxolone. The calculated maximum relative infant dose for ganaxolone was approximately 0.157 mg/kg daily based on an average milk intake of 150 mL/kg daily, which is less than 1% of the maternal dose, and approximately 0.24% the labeled pediatric dose of 63 mg/kg/day.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Substance Name

Ganaxolone

CAS Registry Number

38398-32-2

Drug Class

Breast Feeding

Lactation

Milk, Human

Anticonvulsants

GABA Agents