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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. 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] In a follow-up report, the authors noted that testing of the breastmilk of 10 women who took eculizumab during pregnancy and postpartum had undetectable levels of the drug in breastmilk. The dosage, lower limit of assay and timing of milk samples was not reported.[3]

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.[4]

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.[4]

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 outcome was not stated.[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. Kelly RJ, Hochsmann B, Kulasekararaj A et al. Eculizumab treatment improves outcomes of pregnancy in patients with paroxysmal nocturnal hemoglobinuria. Blood. 2014;124 (21): Abstract #4393.

4. 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

20150310

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