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Omaveloxolone Pregnancy and Breastfeeding Warnings

Brand names: Skyclarys

Medically reviewed by Drugs.com. Last updated on Sep 29, 2023.

Omaveloxolone Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: No data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments: Women of childbearing potential using hormonal contraceptives should be advised to use alternative methods during therapy and for 28 days after discontinuation.

Animal studies have revealed evidence of increased stillbirths and impaired neurobehavioral function in offspring. At the highest dose tested, it reduced body weight, delayed sexual maturity in males, increased postnatal mortality, and impaired reproductive performance in offspring. There are no controlled data in human pregnancy.

See references

Omaveloxolone Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: The effects of this drug on milk production or nursing infant are unknown.

See references

See also

References for pregnancy information

  1. (2023) "Product Information. Skyclarys (omaveloxolone)." Reata Pharmaceuticals, Inc.

References for breastfeeding information

  1. (2023) "Product Information. Skyclarys (omaveloxolone)." Reata Pharmaceuticals, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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