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Cariprazine Pregnancy and Breastfeeding Warnings

Cariprazine is also known as: Vraylar

Cariprazine Pregnancy Warnings

Advise pregnant women of the potential risk to the fetus. Comments: Neonates exposed to antipsychotic drugs during the third trimester of pregnancy should be monitored for extrapyramidal and/or withdrawal symptoms post-delivery. US FDA pregnancy category: Not assigned

Based on animal data, this drug may cause fetal harm. Pregnant rats receiving 0.2 to 3.5 times the maximum recommended human dose experienced fetal developmental toxicity (e.g. low body weight, skeletal malformations, or underdeveloped renal papillae). Impaired fertility was observed in female rats at all dose levels. There are no controlled data in human pregnancy. There have been reports of extrapyramidal and withdrawal symptoms in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. These complications have varied in severity, from self-limited to needing intensive care unit support and prolonged hospitalization. Pregnancy registry: Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-866-961-2388 or visiting http://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/. 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.

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Cariprazine Breastfeeding Warnings

Safety has not been established. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Vraylar (cariprazine)." Actavis Pharma, Inc., Parsippany, NJ.

References for breastfeeding information

  1. "Product Information. Vraylar (cariprazine)." Actavis Pharma, Inc., Parsippany, NJ.

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