Apremilast Use During Breastfeeding
Apremilast should be avoided during breastfeeding due to insufficient safety data in humans, and alternative medications compatible with breastfeeding should be considered instead. 1
Guideline Recommendations
The most recent and authoritative guidance comes from the 2025 EULAR recommendations, which explicitly state that apremilast should be avoided in breastfeeding women and alternative drugs should be considered. 1 This recommendation is based on insufficient data rather than evidence of direct infant harm, but the lack of safety information warrants a cautious approach prioritizing infant safety. 1
The 2020 American College of Rheumatology guideline similarly notes that there is no available evidence regarding use or safety of apremilast during pregnancy or breastfeeding, and the expert panel elected not to offer recommendations for this small-molecule agent. 2, 3
FDA Drug Label Information
The FDA label for apremilast provides critical animal data but confirms the absence of human lactation data:
There are no data on the presence of apremilast in human milk, the effects on the breastfed infant, or the effects on milk production. 4
Apremilast was detected in the milk of lactating mice at concentrations approximately 1.5-times that of simultaneously collected blood samples following a single oral administration. 4
The FDA label states that when a drug is present in animal milk, it is likely that the drug will be present in human milk. 4
The label recommends that the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for apremilast and any potential adverse effects on the breastfed infant. 4
Clinical Reasoning
As a small-molecule PDE4 inhibitor, apremilast is likely to pass into breast milk based on its pharmacokinetic properties and the animal data demonstrating milk concentrations exceeding blood levels. 2, 3, 4 Small molecules generally have greater potential for breast milk transfer compared to large biologic molecules. 2, 3
The concern is not based on documented harm to breastfed infants—no such cases exist—but rather on the complete absence of human safety data combined with confirmed presence in animal milk at significant concentrations. 1, 4
Alternative Approach
For women with rheumatic and musculoskeletal diseases requiring treatment during breastfeeding:
Consider switching to medications with established breastfeeding safety profiles such as TNF inhibitors, hydroxychloroquine, sulfasalazine, or low-dose corticosteroids, which have extensive lactation safety data. 2, 3
If disease control is inadequate with breastfeeding-compatible alternatives, a shared decision-making discussion should weigh the benefits of breastfeeding against the mother's need for disease control with apremilast. 4
If apremilast is deemed essential and no alternatives exist, consider discontinuing breastfeeding rather than exposing the infant to a medication with unknown safety profile. 1
Important Caveats
The recommendation to avoid apremilast during breastfeeding is precautionary rather than based on evidence of harm. 1 However, in the absence of safety data and given the availability of alternative treatments with established lactation safety, the risk-benefit analysis favors avoiding apremilast while breastfeeding. 1
Human lactation studies for apremilast have not been conducted, and no case reports of breastfed infant outcomes exist in the medical literature. 1, 4