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Brexpiprazole Pregnancy and Breastfeeding Warnings

Brexpiprazole is also known as: Rexulti

Brexpiprazole Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. US FDA pregnancy category: Not Assigned Comments: -Neonates exposed to this drug during the third trimester should be monitored for extrapyramidal and/or withdrawal symptoms following delivery. -The National Pregnancy Registry for Atypical Antipsychotics monitors pregnancy outcomes in women exposed to atypical antipsychotics during pregnancy. Information is available at or by phone at 1-866-961-2388.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity; in some cases symptoms have been self-limited and in other cases neonates have required intensive care unit support and prolonged hospitalization. Animal studies have revealed no evidence of teratogenicity, however, pregnant rats receiving 73 times the maximum recommended human dose (MRHD) during the period of organogenesis through lactation had an increased number of perinatal pup deaths. Impaired nursing by dams, low birth weight, and decreased body weight gain in pups were observed at 73 times MRHD, but not at 24 times the MRHD. There are no controlled data in human pregnancy. 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

Brexpiprazole Breastfeeding Warnings

Lactation studies have not been conducted to assess the effects of this drug on the breastfed infant or the effects on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the mother's medical condition. Excreted into human milk: Unknown Excreted into animal milk: Yes The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc, Rockville, MD.

References for breastfeeding information

  1. "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc, Rockville, MD.

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