Is Dupilumab safe while breastfeeding?

Summary of use during breastfeeding

Evidence indicates that dupilumab is acceptable to use during breastfeeding. Because dupilumab is a large protein molecule with a molecular weight of about 147,000 Da, the amount in milk is likely to be very low.[1] It is also likely to be partially destroyed in the infant’s gastrointestinal tract and absorption by the infant is probably minimal.[2] Expert opinions consider dupilumab acceptable during breastfeeding.[3-5] Waiting for at least 2 weeks postpartum to resume therapy may minimize transfer to the infant.[6] Until more data become available, dupilumab should be used with caution while nursing a newborn or preterm infant.

Effects on the breastfed infant

A woman with atopic eczema received dupilumab subcutaneously in a dose of 300 mg every 2 weeks during pregnancy and postpartum. She breastfed her infant (extent not stated) for at least 4 months during which no complications were reported.[8,9] Seven months after delivery, she became pregnant again and continued dupilumab at the same dose throughout the pregnancy and lactation. No complications were seen during breastfeeding.[10]

Eight women with atopic dermatitis received dupilumab during pregnancy and breastfeeding. Two breastfed for 1 month, one for 7.2 months, one for 8.8 months, one for 10 months, one for 11.5 months, one for 14.5 months, and one for 16.1 months. None of the babies had developed atopic dermatitis at the time of publication and no adverse effects were reported.[11]

A woman in Portugal with long-standing atopic dermatitis began dupilumab therapy (dose not stated) with good results. She became pregnant and continued dupilumab. She delivered a healthy infant and breastfed for 8 months (extent not stated). The breastfed infant had no complications.[12]

A woman with long-standing atopic dermatitis began receiving dupilumab 300 mg every 2 weeks. When she became pregnant 24 months later, she stopped the drug, but had a disease flare in 2 weeks. The drug was restarted and she continued receiving it throughout the pregnancy and postpartum. She breastfed (extent and duration not stated) her infant. At 18 months of age, the infant had no complications.[13]

Investigators in Portugal reported a retrospective study of moderate-to-severe atopic dermatitis treated with dupilumab during pregnancy and breastfeeding in three tertiary medical centers. Two women with atopic dermatitis and allergic rhinitis took dupilumab for 9 and 18 months, respectively, while breastfeeding their infants. The exact dosage and extent of breastfeeding were not specified. The infants showed normal development and weight gain.[14]

A woman developed severe pemphigoid gestationis that was treated with corticosteroids during pregnancy. Postpartum she was given dupilumab 600 mg as a loading dose 2 weeks postpartum, followed by 300 mg every 2 weeks for 45 weeks. She breastfed without significant adverse effects to the infant.[15]

Effects on milk supply

Relevant published information was not found as of the revision date.

Levels in milk

Maternal Levels. A woman began receiving dupilumab 300 mg subcutaneously every 2 weeks starting 2.5 months after delivery. A milk sample 3 days after a dose had a dupilumab concentration of 1.1 mg/L, which was 1.3% of the simultaneous maternal plasma concentration.[7]

Infant Levels. Relevant published information was not found as of the revision date.