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Lumateperone Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Jun 21, 2022.

Lumateperone is also known as: Caplyta

Lumateperone Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: There are insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

-A pregnancy exposure registry is available.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Untreated schizophrenia may increase risks to the mother.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder have been reported in neonates exposed to antipsychotics during the third trimester of pregnancy; cases have varied widely in severity from recovery within hours to days to reports of neonates who have required intensive support and prolonged hospitalization. In animal studies using oral doses up to 3.5 mg/kg/day (rats) and 7 mg/kg/day (rabbits), corresponding to 2.4 and 9.7 times the maximal recommended human dose (MRHD), respectively, malformations and adverse developmental effects were not observed. Studies in rats during organogenesis to weaning given oral doses of 10.5 mg/kg/day or higher (at least 4.9 times MRHD based on mg/m2) showed decreased body weight, incomplete ossification, visceral and skeletal variations, early postnatal death, impaired nursing, and decreased pup body weight gain. Animal studies given a human metabolite of this drug have revealed an increase in visceral malformations (e.g., cleft palate) and skeletal malformations at doses that resulted in maternal toxicity. Male and female fertility may be impaired. There are no controlled data in human pregnancy.

Pregnant patients with untreated schizophrenia have an increased risk of hospitalization, risk of relapse, and suicide compared to treated patients. Untreated schizophrenia has been associated with an increase in adverse perinatal outcomes (e.g., preterm birth); however, it is unknown whether this is a direct result of the illness or other factors.

To monitor the outcomes of pregnant women exposed to this atypical antipsychotic, the National Pregnancy Registry for Atypical Antipsychotics registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-866-961-2388 or online at

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Lumateperone Breastfeeding Warnings

Aniline metabolites of this drug are associated with toxicity in animal models; however, aniline metabolites were not measured in adult humans at quantifiable levels during clinical trials. It is unknown whether infants will have comparable drug metabolism to adults.

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

-The effects in the nursing infant are unknown.
-Animal models have revealed evidence of toxicity.
-Extrapyramidal symptoms (e.g., abnormal muscle movements, tremors), failure to thrive, jitteriness, and sedation have been reported in breastfed infants exposed to antipsychotic agents.

See references

References for pregnancy information

  1. "Product Information. Caplyta (lumateperone)." Intra-Cellular Therapies, Inc. (2020):

References for breastfeeding information

  1. "Product Information. Caplyta (lumateperone)." Intra-Cellular Therapies, Inc. (2020):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.