Rexulti Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of brexpiprazole in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Pharmacodynamics: Toxicology: Preclinical safety data under Actions). Brexpiprazole is not recommended during pregnancy and in women of childbearing potential not using contraception.
Neonates exposed to antipsychotics, including brexpiprazole, during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder. Consequently, new-borns should be monitored carefully.
Breast-feeding: It is unknown whether brexpiprazole/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of brexpiprazole/ metabolites in milk of rats (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the new-borns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from brexpiprazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: The effect of brexpiprazole on human fertility has been evaluated. Studies in animals have shown decreased female fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).