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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.

Drug Levels

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.[1]

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.[2]

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.[3]

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.[1]

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.[3]

Effects on Lactation and Breastmilk

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

References

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

Eculizumab Identification

Substance Name

Eculizumab

CAS Registry Number

219685-50-4

Drug Class

Antibodies, Monoclonal

Administrative Information

LactMed Record Number

999

Last Revision Date

20151001

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Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

Disclaimer: This information is not intended as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. Use of this website signifies your agreement to the Terms of Use and Online Privacy Policy.

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