Summary of Use during Lactation

No information is available on the clinical use of lumateperone during breastfeeding. However, amounts of lumateperone and its metabolites in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. If lumateperone is required by the mother, it is not a reason to discontinue breastfeeding

Drug Levels

Maternal Levels. The manufacturer reports a lactation study in 17 lactating women that evaluated the concentrations of lumateperone and its metabolites in plasma and mature breast milk following a single dose of 42 mg of lumateperone. The estimated daily infant dose of lumateperone in human milk was 0.0004 mg/kg (with assumed average daily milk consumption of 200 mL/kg). The mean relative infant dose (with an assumed mean daily milk consumption of 200 mL/kg and average maternal weight of 71 kg) was 0.06% of the maternal weight-adjusted dosage. Several major circulating metabolites were also present in breastmilk at estimated daily infant dose of 0.0004 mg/kg. Aniline metabolites were not detectable in milk or maternal plasma at quantifiable levels.

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.

Alternate Drugs to Consider

(Antipsychotic) Haloperidol, Olanzapine, Risperidone, Quetiapine (Bipolar Disorder) Divalproex, Lithium, Olanzapine, Quetiapine, Risperidone, Valproic Acid

Substance Name

Lumateperone

CAS Registry Number

313368-91-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Antipsychotic Agents