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Eculizumab use while Breastfeeding

Drugs containing Eculizumab: Soliris

Eculizumab Levels and Effects while Breastfeeding

Summary of Use during Lactation

Information from three patients indicates that a therapeutic 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 two infants who were breastfed during maternal therapy. Until more data become available, eculizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. One woman with paroxysmal nocturnal hemoglobinuria had received eculizumab for 5 years before becoming pregnant. She continued to receive the drug during pregnancy at a dosage of 900 mg every 12 days and postpartum. At delivery, she had a therapeutic eculizumab serum concentration of 116.1 mg/L. Breastmilk samples taken on days 1, 2, 3, 9 and 10 after delivery contained no detectable drug (lower limit of assay and time of last dose not stated).[1][2]

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.[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.[3]

Effects on Lactation and Breastmilk

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

References

1. Kelly R, Arnold LM, Richards SJ, Hill A, Bomken C, Hanley J et al. Successful pregnancy outcome in paroxysmal nocturnal haemoglobinuria on long term eculizumab. Haematologica. 2009;94 (Suppl. 2):452. Abstract.

2. Kelly R, Arnold L, Richards S, Hill A, Bomken C, Hanley J et al. The management of pregnancy in paroxysmal nocturnal haemoglobinuria on long term eculizumab. Br J Haematol. 2010;149:446-50. PMID: 20151973

3. 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

Eculizumab Identification

Substance Name

Eculizumab

CAS Registry Number

219685-50-4

Drug Class

Antibodies, Monoclonal

Administrative Information

LactMed Record Number

999

Last Revision Date

20140515

Disclaimer

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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