Eculizumab use while Breastfeeding
Drugs containing Eculizumab: Soliris
Medically reviewed by Drugs.com. Last updated on July 13, 2020.
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, 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.
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.
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.
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.
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. 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.
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.
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.
One center reported a cohort of 14 women who received eculizumab for paroxysmal nocturnal hemoglobinuria during pregnancy. Ten of the infants were breastfed (extent not stated) with no reported complications.[6,7]
A mother with paroxysmal nocturnal hemoglobinuria became pregnant while on eculizumab and continued the drug during pregnancy and lactation. During the third trimester and immediately postpartum she was receiving 1200 mg weekly; one moth postpartum, her dosage was decreased to 900 mg every 2 weeks. She continued to breastfeed her baby (amount not stated). At 3 months of age, the infant was developing normally.
A woman with paroxysmal nocturnal hemoglobinuria was treated during late pregnancy with eculizumab 1200 mg weekly. One month after delivery, she returned to her prepregnancy dosage of 900 mg biweekly. She breastfeed her baby for six months without complications. At one year of age, the infant was developing well for her age.
The manufacturer's pharmacovigilance database was analyzed by academic and manufacturer personnel. There were 31 reports of mothers breastfeeding their infants during eculizumab therapy, 20 patients with paroxysmal nocturnal hemoglobinuria and 11 patients with atypical hemolytic uremic syndrome. Neither dosages nor extent of breastfeeding were reported, and some of the cases might have been reported elsewhere previously. None of the breastfed infants had any adverse effects.
Effects on Lactation and Breastmilk
Relevant published information was not found as of the revision date.
Sarris I, Gandhi S, Koumis A, et al. Pregnancy outcome and safety of breastfeeding in two patients with paroxysmal nocturnal haemoglobinuria (PNH) treated with eculizumab. Arch Dis Child Fetal Neonatal Ed 2012;97(Suppl. 1):Abstract PP.43 current. doi:10.1136/fetalneonatal-2012-301809.388. [CrossRef]
Ando Y, Kida M, Saika M, et al. Pregnancy and delivery in a PNH patient treated with eculizumab. Rinsho Ketsueki. 2014;55:2288–93. [PubMed: 25501409]
Kelly RJ, Hochsmann B, Szer J, et al. Eculizumab in pregnant patients with paroxysmal nocturnal hemoglobinuria. N Engl J Med. 2015;373:1032–9. [PubMed: 26352814]
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. [PMC free article: PMC4454784] [PubMed: 26052501]
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. [PubMed: 26857155]
Vinogradova M, Kulagin A, Kirsanova T, et al. Pregnancy outcomes in paroxysmal nocturnal hemoglobinuria depending on the therapeutic approach. Br J Haematol 2017;176 (Suppl):94-5. Abstract. PMID: 28297073.
Vinogradova MA, Kulagin A, Shmakov R, et al. The pregnancy course and outcomes during targeted therapy of paroxysmal nocturnal hemoglobinuria. Blood 2016;128:2397. Abstract. doi:10.1182/blood.V128.22.2397.2397. [CrossRef]
Aydin S, Audisio E, Iovino G, et al. Breakthrough hemolysis controlled by eculizumab escalation during pregnancy in paroxysmal noctural hemoglobinuria (PNH): A single case report. Haematologica. 2017;102 Suppl 3:58. http://www
.haematologicaAbstract. . .org/content/102/s3/1.full.pdf+html
Frairia C, Aydin S, Audisio E, et al. Breakthrough hemolysis and thromboembolism controlled by eculizumab during pregnancy in paroxysmal noctural hemoglobinuria (PNH): A single institution experience. HemaSphere 2018;2 (Suppl 2):835-6. Abstract. doi:10.1097/HS9.0000000000000060. [CrossRef]
Socié G, Caby-Tosi MP, Marantz JL, et al. Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10-year pharmacovigilance analysis. Br J Haematol. 2019;185:297–310. [PMC free article: PMC6594003] [PubMed: 30768680]
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