Pegcetacoplan and Breastfeeding

Summary of use during lactation

No information is available on the use of pegcetacoplan during breastfeeding. Since only a small dose in injected intravitreally into the eye, it is unlikely that a clinically relevant amount would reach the infant in breastmilk. Pegcetacoplan was undetectable in the milk of one mother after systemic use; however, the manufacturer recommends that breastfeeding be discontinued during treatment and for 40 days after the last dose.

Drug levels in milk and infant serum

Maternal Levels. A woman with hemolytic paroxysmal nocturnal hemoglobinuria became pregnant. She was treated with pegcetacoplan 1080 mg subcutaneous three times a week near term. Two milk samples obtained on days 1 and 2 postpartum contained undetectable (<20 mg/L) amounts of pegcetacoplan. The time of the previous dose was not specified, but blood samples taken on the same days contained pegcetacoplan in therapeutic concentrations of 719 and 635 mg/L.[1] Infant Levels. Relevant published information was not found as of the revision date.

Effects in breastfed infants

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

Effects on lactation and breastmilk

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

Alternative drugs to consider

(Paroxysmal Nocturnal Hemoglobinuria) Eculizumab

References

1. Chin-Yee B, Hedley BD, Su R, et al. Paroxysmal nocturnal hemoglobinuria in pregnancy treated with pegcetacoplan: Case report and pharmacokinetic analysis. EJHaem 2025;6:e70179.41268092 PubMed