Apremilast Pregnancy and Breastfeeding Warnings
Apremilast is also known as: Otezla
Medically reviewed by Drugs.com. Last updated on July 9, 2020.
Apremilast 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: C
Animal studies have revealed dose related increases in abortion/embryo-fetal death. There are no controlled data in human pregnancy.
To monitor pregnancy outcomes, a US pregnancy exposure registry has been established. Information about the registry can be obtained by calling 1-877-311-8972.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Apremilast Breastfeeding Warnings
Caution is recommended
Excreted into human milk: Unknown
Excreted into animal milk: Yes
References for pregnancy information
- "Product Information. Otezla (apremilast)." Celgene Corporation, Summit, NJ.
References for breastfeeding information
- "Product Information. Otezla (apremilast)." Celgene Corporation, Summit, NJ.
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.