The Basics

What is Brexpiprazole?

Used in the treatment of schizophrenia and as an adjunct for major depressive disorder.

Brand names for Brexpiprazole

Rexulti

How Brexpiprazole is classified

Antipsychotic Agents

Brexpiprazole During Pregnancy

Brexpiprazole pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Brexpiprazole while pregnant

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to REXULTI during pregnancy. For more information contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Risk Summary Adequate and well-controlled studies have not been conducted with REXULTI in pregnant women to inform drugassociated risks. However, neonates whose mothers are exposed to antipsychotic drugs, like REXULTI, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. In animal reproduction studies, no teratogenicity was observed with oral administration of brexpiprazole to pregnant rats and rabbits during organogenesis at doses up to 73 and 146 times, respectively, of maximum recommended human dose (MRHD) of 4 mg/day on a mg/m² basis. However, when pregnant rats were administered brexpiprazole during the period of organogenesis through lactation, the number of perinatal deaths of pups was increased at 73 times the MRHD . The background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Taking Brexpiprazole While Breastfeeding

What are recommendations for lactation if you're taking Brexpiprazole?

No information is available on the use of brexpiprazole during breastfeeding. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Maternal / infant drug levels

No information is available on the use of brexpiprazole during breastfeeding. Until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Possible effects of Brexpiprazole on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Brexpiprazole

Haloperidol, Olanzapine, Quetiapine, Risperidone.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/None listed

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

Read This Next

Paliperidone

Paliperidone and pregnancy or breastfeeding: Is it safe?

Read More

As seen in

Join our mailing list

Sign up for access to exclusive promotions, latest news and opportunites to test new pre-release products