The Basics
What is Eculizumab?
Indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
Brand names for Eculizumab
Soliris
How Eculizumab is classified
Antibodies – Monoclonal, Dermatologic Agents
Eculizumab During Pregnancy
Eculizumab pregnancy category
Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.
What we know about taking Eculizumab while pregnant
Limited data on outcomes of pregnancies that have occurred following Soliris use in pregnant women have not identified a concern for specific adverse developmental outcomes (see Data). There are risks to the mother and fetus associated with untreated paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS) in pregnancy (see Clinical Considerations). Animal studies using a mouse analogue of the Soliris molecule (murine anti-C5 antibody) showed increased rates of developmental abnormalities and an increased rate of dead and moribund offspring at doses 2-8 times the human dose (see Data). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 1520%, respectively.
Taking Eculizumab While Breastfeeding
What are recommendations for lactation if you're taking Eculizumab?
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.
Maternal / infant drug levels
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.
Possible effects of Eculizumab on milk supply
Relevant published information was not found as of the revision date.
Possible alternatives to Eculizumab
None listed
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. 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
6. 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.
7. 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
8. 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. Abstract.
9. 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: doi:10.1097/HS9.0000000000000060
10. Socie G, Caby-Tosi MP, Marantz JL, Cole A, Bedrosian CL, Gasteyger C et al. Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10-year pharmacovigilance analysis. Br J Haematol. 2019;185:297-310. PMID: 30768680
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
