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 in milk and infant serum
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.
Source: Drugs and Lactation Database (LactMed®), National Institute of Child Health and Human Development, NCBI Bookshelf. Check LactMed for the most recent revision.
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