Apremilast Pregnancy and Breastfeeding Warnings
Apremilast is also known as: Otezla
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.
See Also...
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
