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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 usually 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 have been reported in 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]

A woman with paroxysmal nocturnal hemoglobinuria was found to be pregnant at 20 weeks of gestation. She was treated with eculizumab 900 mg weekly starting at 30 weeks of gestation and then 1200 mg every 2 weeks beginning at 34 weeks of gestation. The drug was continued at this dosage throughout the pregnancy and for 3 months postpartum. The patient delivered at 36 weeks of gestation and eculizumab was undetectable (assay limit not specified) in breastmilk at that time.[4] The time between the last dose and measurement of milk levels was not stated.

Three cases of Japanese women treated for paroxysmal nocturnal hemoglobinuria reportedly were given eculizumab during pregnancy and postpartum. The dosage was 900 mg every 2 weeks in two cases and unstated in the third. Eculizumab was undetectable (assay limit not specified) in breastmilk in all cases, apparently at the time of delivery.[5]

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

4. Sharma R, Keyzner A, Liu J et al. Successful pregnancy outcome in paroxysmal nocturnal hemoglobinuria (PNH) following escalated eculizumab dosing to control breakthrough hemolysis. Leuk Res Rep. 2015;4:36-8. PMID: 26052501

5. Miyasaka N, Miura O, Kawaguchi T et al. Pregnancy outcomes of patients with paroxysmal nocturnal hemoglobinuria treated with eculizumab: A Japanese experience and updated review. Int J Hematol. 2016;103:703-12. PMID: 26857155

Eculizumab Identification

Substance Name

Eculizumab

CAS Registry Number

219685-50-4

Drug Class

Antibodies, Monoclonal

Administrative Information

LactMed Record Number

999

Last Revision Date

20160819

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