Is Brexpiprazole safe while breastfeeding?

Effects on the breastfed infant

Three mothers who took brexpiprazole 1 or 2 mg daily during pregnancy and postpartum delivered infants who partially breastfed. All had mild neonatal jaundice, which was thought to not be related to the drug. All infants were gaining weight and developing normally at one month of age and no adverse drug effects were reported.[ 2 ]

Effects on milk supply

A woman was taking brexpiprazole 2 mg daily during the third trimester of pregnancy for bipolar disorder. Her newborn infant was hospitalized in the NICU for hypoxic ischemic encephalopathy for 18 days. While her infant was in the NICU, she reduced her brexpiprazole dose to 2 mg every 2 days because of a shortage of medication. The mother, who had successfully breastfed 2 previous infants, pumped milk 10 times daily and was able to pump 120 mL daily by one week postpartum. After her infant was discharged, she increased the dose back to 2 mg daily. At a follow-up clinic visit, she could only pump 30 mL daily. She then stopped brexpiprazole and began a short course of metoclopramide. Within 10 days of stopping brexpiprazole, her milk supply increased, and she could almost exclusively breastfeed her infant who gained weight normally. Her serum prolactin level also increased to normal.[ 3 ] A review of case reports of adverse reactions reported in the US Food and Drug Administration s Adverse Event Reporting System from 2015 to 2023 found 6 reports of lactation disorder and 10 cases of breast discharge reported with brexpiprazole. Other details were lacking.[ 4 ] Three mothers took brexpiprazole 1 or 2 mg daily during pregnancy and postpartum. All of them had to feed both formula and breastmilk, suggesting that the drug might suppress lactation. However, one of the infants was born with a cleft palate that made breastfeeding difficult.[ 2 ] A 26-year-old woman with paranoid schizophrenia was started on paliperidone 12 mg daily. Twenty-six days after treatment initiation a satisfactory plasma paliperidone level of 42 mcg/L was achieved (therapeutic range 20 to 60 mcg/L). The patient developed galactorrhea 4 weeks following paliperidone initiation. Two serial prolactin measurements, weeks 4 and 5 weeks after treatment onset revealed persistent elevation of prolactin above the upper limit of normal, at 130 mcg/L (physiological range 5 to 23 mcg /L). Brexpiprazole 1 mg dail

Levels in milk

Maternal Levels. A woman with schizophrenia received brexpiprazole 2 mg once daily, risperidone 2 mg twice daily and quetiapine 12.5 mg twice daily during pregnancy and postpartum. Concentrations of brexpiprazole in breastmilk were 1 mcg/L on day 4 approximately 2 hours after the last dose, 2.3 mcg/L on day 5 at 6.5 hours after the last dose, and 6 mcg/L on day 6 at 22 hours after the last dose. The authors estimated the relative infant dose to be about 0.7%, although an insufficient amount of sampling was performed to verify this value.[ 1 ] Infant Levels. A breastfed newborn infant whose mother was taking brexpiprazole 2 mg once daily, risperidone 2 mg twice daily and quetiapine 12.5 mg twice daily during pregnancy and postpartum had serum levels measured. At birth, the cord blood level was 3.9 mcg/L from maternal use during pregnancy. The neonate ingested small volumes of colostrum and milk 12 times from 46 to 86.5 hours after birth. Serum levels declined with a half-life of 45.9 hours between 16.5 and 41 hours after birth. By about 115 hours postpartum, brexpiprazole was undetectable ( 0.5 mcg/L) in the infant s serum.[ 1 ]

Alternatives LactMed lists

• Haloperidol
• Olanzapine
• Quetiapine
• Risperidone