Last update April 27, 2022

Eculizumab

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Eculizumab is a recombinant humanized monoclonal antibody that acts as a complement blocker. It is indicated in paroxysmal nocturnal hemoglobinuria, atypical hemolytic-uremic syndrome, optic neuromyeliis and some forms of myasthenia gravis. Weekly intravenous infusion administration.

It is excreted in breast milk in an undetectable or clinically insignificant amount (Miyasaka 2016, Kelly 2015, Sharma 2015, Ando 2014, Sarris 2012) and no problems have been observed in infants of mothers treated with this drug. (Socié 2019, Frairia 2018, Kelly 2015, Sarris 2012)

Furthermore, due to its protein nature, it is inactivated in the gastrointestinal tract without being absorbed (practically nil oral bioavailability) and this hinders or prevents its passage into the infant´s plasma from ingested breast milk (Hale, Lactmed) except for premature infants and during the immediate neonatal period when there might be a greater intestinal permeability.

Alternatives

We do not have alternatives for Eculizumab since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Eculizumab in other languages or writings:

Groups

Eculizumab belongs to these groups or families:

Tradenames

Main tradenames from several countries containing Eculizumab in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. ≈ 0 %
Molecular weight 148.000 daltons
VD 0.07 - 0.11 l/Kg
272 ± 82 hours
M/P ratio 0 -
Theoretical Dose 0 mg/Kg/d
Relative Dose 0 %

References

  1. Socié G, Caby-Tosi MP, Marantz JL, Cole A, Bedrosian CL, Gasteyger C, Mujeebuddin A, Hillmen P, Vande Walle J, Haller H. Eculizumab in paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome: 10-year pharmacovigilance analysis. Br J Haematol. 2019 Apr;185(2):297-310. Abstract
  2. Alexion Ph. Eculizumab (Soliris). Drug Summary. 2018 Full text (in our servers)
  3. Frairia C, Aydin S, Audisio E, D’Ardia S, Iovino G, Nicolino B, Macchi C, Zizzo F, Comoglio FM, Todros T, Vitolo U. (23rd Congress of the European Hematology Association Stockholm, Sweden, June 14-17, 2018). 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 PB1835. Full text (link to original source) Full text (in our servers)
  4. Miyasaka N, Miura O, Kawaguchi T, Arima N, Morishita E, Usuki K, Morita Y, Nishiwaki K, Ninomiya H, Gotoh A, Imashuku S, Urabe A, Shichishima T, Nishimura J, Kanakura Y. Pregnancy outcomes of patients with paroxysmal nocturnal hemoglobinuria treated with eculizumab: a Japanese experience and updated review. Int J Hematol. 2016 Jun;103(6):703-12. Abstract
  5. Kelly RJ, Höchsmann B, Szer J, Kulasekararaj A, de Guibert S, Röth A, Weitz IC, Armstrong E, Risitano AM, Patriquin CJ, Terriou L, Muus P, Hill A, Turner MP, Schrezenmeier H, Peffault de Latour R. Eculizumab in Pregnant Patients with Paroxysmal Nocturnal Hemoglobinuria. N Engl J Med. 2015 Sep 10;373(11):1032-9. Abstract
  6. Sharma R, Keyzner A, Liu J, Bradley T, Allen SL. Successful pregnancy outcome in paroxysmal nocturnal hemoglobinuria (PNH) following escalated eculizumab dosing to control breakthrough hemolysis. Leuk Res Rep. 2015 May 16;4(1):36-8. Abstract
  7. Ando Y, Kida M, Saika M, Chizuka A, Hangaishi A, Urabe A, Usuki K. Pregnancy and delivery in a PNH patient treated with eculizumab. Rinsho Ketsueki. 2014 Nov;55(11):2288-93. Japanese. Abstract
  8. Sarris I, Gandhi S, Koumis A, Elebute M, Shehata H, Penna L. Abstra Pregnancy outcome and safety of breastfeeding in two patients with paroxysmal nocturnal haemoglobinuria (PNH) treated with eculizumab. Arch Dis Child Fetal Neonatal 2012;97(Suppl. 1):Abstract p.43 Abstract
  9. EMA. Eculizumab (Soliris). Ficha técnica. 2012 Full text (in our servers)

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