Eculizumab use while Breastfeeding
Drugs containing Eculizumab: Soliris
Eculizumab Levels and Effects while Breastfeeding
Summary of Use during Lactation
Maternal dosages of eculizumab produce undetectable levels in breastmilk. Because eculizumab is a large protein molecule with a molecular weight of about 148,000, absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. No adverse effects attributable to eculizumab were reported in numerous infants who were breastfed during maternal therapy.
Maternal Levels. Two women began treatment with eculizumab for paroxysmal nocturnal hemoglobinuria during pregnancy and continued receiving the drug postpartum while breastfeeding their infants. Serum and breastmilk samples were obtained at 12 hours and 5 days after their last dose. Eculizumab was not detectable (assay limit not specified) in breastmilk despite therapeutic serum concentrations.
A woman treated with eculizumab 900 mg twice weekly for paroxysmal nocturnal hemoglobinuria during pregnancy had her breastmilk tested for the presence of the drug. She received a dose one day after delivery. A milk sample one day later had detectable eculizumab, but in an amount less than 35 mg/L. Eight more breastmilk samples taken up to 12 days postpartum and 13 days after the postpartum dose had no detectable eculizumab.
Twenty-five women were identified who were taking eculizumab for paroxysmal nocturnal hemoglobinuria during breastfeeding. Ten of the women receiving unstated dosages of the drug had a breastmilk sample tested for eculizumab, which was undetectable (<5 mg/L) in all samples.
Infant Levels. Relevant published information was not found as of the revision date.
Effects in Breastfed Infants
Two women began treatment with eculizumab during pregnancy and continued receiving the drug postpartum while breastfeeding their infants. One infant had no complications up to 30 weeks of follow-up. The other infant developed neutropenia up to 12 weeks of age, but it was not attributed to eculizumab.
A group of authors associated with the manufacturer of the drug reported that 25 patients had breastfed while taking eculizumab for paroxysmal nocturnal hemoglobinuria. Infant outcomes were not stated.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
1. Sarris I, Gandhi S, Koumis A et al. Pregnancy outcome and safety of breast-feeding in two patients with paroxysmal nocturnal haemoglobinuria (PNH) treated with eculizumab. Arch Dis Child Fetal Neonatal Ed. 2012;97:A119. Abstract PP.43. DOI: doi:10.1136/fetalneonatal-2012-301809.388
2. Ando Y, Kida M, Saika M et al. Pregnancy and delivery in a PNH patient treated with eculizumab. Rinsho Ketsueki. 2014;55:2288-93. PMID: 25501409
3. Kelly RJ, Hochsmann B, Szer J et al. Eculizumab in pregnant patients with paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2015;373:1032-9. PMID: 26352814
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