Is apremilast safe for use during breastfeeding?

Apremilast Should Be Avoided During Breastfeeding

Apremilast is not suitable for breastfeeding and should be avoided; alternative drugs compatible with breastfeeding should be considered instead. This recommendation is based on insufficient safety data in breastfeeding women, not evidence of harm, but the lack of information necessitates a cautious approach to protect infant safety.

Evidence-Based Rationale

The most recent and authoritative guidance comes from the 2025 EULAR recommendations, which explicitly state that apremilast should be avoided in breastfeeding women due to insufficient data 1. This represents the highest quality guideline evidence available and directly addresses your question.

Key Supporting Evidence:

From Guidelines:

• The EULAR 2025 guidelines categorize apremilast under drugs with "limited or no data on breastfeeding" that should be avoided, with alternative drugs considered 1
• The rationale is insufficient data rather than evidence of infant harm - an important distinction that reflects the precautionary principle in clinical practice 1

From FDA Drug Label:

• There are no data on the presence of apremilast in human milk, effects on breastfed infants, or effects on milk production 2
• Animal data shows apremilast was detected in mouse milk at concentrations approximately 1.5-times that of blood samples 2
• The FDA label states: "When a drug is present in animal milk, it is likely that the drug will be present in human milk" 2

Clinical Decision-Making Algorithm

If a breastfeeding patient requires treatment for psoriasis or psoriatic arthritis:

1. First-line approach: Switch to breastfeeding-compatible alternatives before initiating or continuing apremilast
2. Risk-benefit discussion: If no suitable alternatives exist, the developmental and health benefits of breastfeeding must be weighed against the mother's clinical need for apremilast 2
3. If apremilast is deemed essential: Consider discontinuing breastfeeding rather than exposing the infant to unknown risks

Important Caveats

• The 2020 AAD-NPF psoriasis guidelines do not specifically address breastfeeding with apremilast, only noting lack of pregnancy data 3
• Unlike some drugs with limited data (such as methotrexate ≤25 mg weekly, bosentan, or sildenafil) that may be considered during breastfeeding when no alternatives exist, apremilast is explicitly categorized in the "should be avoided" group 1
• The animal data showing drug transfer into milk at 1.5-times blood concentration is concerning and supports the avoidance recommendation 2

Practical Considerations

Common pitfall: Assuming that because apremilast has a favorable safety profile in adults (no requirement for laboratory monitoring, acceptable adverse event profile) 3, it would be safe during breastfeeding. This is incorrect - the concern is specifically about infant exposure through breast milk, not maternal safety.

Alternative approach: Many other systemic treatments for psoriasis have established safety data in breastfeeding. Discuss these options with the patient rather than proceeding with apremilast during lactation.