SUMMARY  

• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including CAPLYTA, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/.¹  
• There is risk to the mother from untreated schizophrenia, including increased risk of relapse, hospitalization, and suicide. Schizophrenia is associated with increased adverse perinatal outcomes, including preterm birth. It is not known if this is a direct result of the illness or other comorbid factors.¹ 
• Extrapyramidal and/or withdrawal symptoms, including agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates who were exposed to antipsychotic drugs during the third trimester of pregnancy. These symptoms have varied in severity. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately. Some neonates recovered within hours or days without specific treatment; others required prolonged hospitalization.¹  
• There is insufficient evidence on CAPLYTA use in pregnant women to establish any drug associated risks for birth defects, miscarriage, or adverse maternal or fetal outcomes.¹
• Lumateperone and its metabolites are present in human breast milk in low amounts. There are no data on the effects of lumateperone on the breastfed infant or the effects on milk production.¹ 
• The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAPLYTA and any potential adverse effects on the breastfed child from CAPLYTA or from the underlying maternal condition.¹  
• No prospective, randomized trials have been conducted to evaluate the safety and efficacy of CAPLYTA in patients who are pregnant or breastfeeding.¹  

PRODUCT LABELING

Please refer to the following section of the full Prescribing Information that is relevant to your inquiry: USE IN SPECIFIC POPULATIONS.¹ 

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) conducted on 12 September 2025 did not identify any relevant citations pertaining to this topic.