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Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-.
CASRN: 913611-97-9
Drug Levels and Effects
Summary of Use during Lactation
No information is available on the excretion of brexpiprazole in breastmilk. A single case report implicated brexpiprazole as a cause of decreased lactation. A review of case reports found lactation disorders and breast secretion reported as side effects, but details are lacking. Until more data are available, an alternate drug may be preferred.
Drug Levels
Maternal Levels. Relevant published information was not found as of the revision date.
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
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.[1]
A review of case reports of adverse reactions reported in the US Food and Drug Administration’s Adverse Event Reporting Systemfrom 2015 to 2023 found 6 reports of “lactation disorder” and 10 cases of “breast discharge” reported with brexpiprazole. Other details were lacking.[2]
Alternate Drugs to Consider
References
- 1.
- Berlin S, Bodnar K. Low breast milk production associated with brexipiprazole (Rexulti). Breastfeed Med 2020;15:A-3. doi:10.1089/bfm.2020.29162.abstracts [CrossRef]
- 2.
- Jiang Y, Zhou L, Shen Y, et al. Safety assessment of brexpiprazole: Real-world adverse event analysis from the FAERS database. J Affect Disord 2024;346:223-9. [PubMed: 37956832]
Substance Identification
Substance Name
Brexpiprazole
CAS Registry Number
913611-97-9
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- Brexpiprazole II: antipsychotic-like and procognitive effects of a novel serotonin-dopamine activity modulator.[J Pharmacol Exp Ther. 2014]Brexpiprazole II: antipsychotic-like and procognitive effects of a novel serotonin-dopamine activity modulator.Maeda K, Lerdrup L, Sugino H, Akazawa H, Amada N, McQuade RD, Stensbøl TB, Bundgaard C, Arnt J, Kikuchi T. J Pharmacol Exp Ther. 2014 Sep; 350(3):605-14. Epub 2014 Jun 19.
- Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator.[J Pharmacol Exp Ther. 2014]Brexpiprazole I: in vitro and in vivo characterization of a novel serotonin-dopamine activity modulator.Maeda K, Sugino H, Akazawa H, Amada N, Shimada J, Futamura T, Yamashita H, Ito N, McQuade RD, Mørk A, et al. J Pharmacol Exp Ther. 2014 Sep; 350(3):589-604. Epub 2014 Jun 19.
- Improvement of dizocilpine-induced social recognition deficits in mice by brexpiprazole, a novel serotonin-dopamine activity modulator.[Eur Neuropsychopharmacol. 2015]Improvement of dizocilpine-induced social recognition deficits in mice by brexpiprazole, a novel serotonin-dopamine activity modulator.Yoshimi N, Futamura T, Hashimoto K. Eur Neuropsychopharmacol. 2015 Mar; 25(3):356-64. Epub 2015 Jan 5.
- Brexpiprazole - Drugs and Lactation Database (LactMed®)Brexpiprazole - Drugs and Lactation Database (LactMed®)
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