Summary of Use during Lactation

Methoxy polyethylene glycol-epoetin beta is a synthetic form of erythropoietin that slowly releases the active drug, epoetin beta (recombinant human erythropoietin). Erythropoietin is a normal component of human milk. The excretion of exogenous methoxy polyethylene glycol-epoetin beta in breastmilk has not been studied; although the similar drug epoetin alfa has been studied and is considered to be acceptable during breastfeeding. Since no information is available on its use during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

A study on Holder pasteurization of breastmilk found that the erythropoietin concentration in breastmilk dropped from about 1.9 international units/L before pasteurization to about 0.5 international units/L after pasteurization.[1]

Drug Levels

Maternal Levels. Relevant published information on exogenous administration of epoetin beta was not found as of the revision date. However, breastmilk normally contains erythropoietin. Erythropoietin concentrations in human milk are in the range of approximately 4 to 5 units/L in the first 1 to 2 months postpartum and increase to 20 to 40 units/L by the third month and to 100 to 150 units/L by 12 months.[2]

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

Effects in Breastfed Infants

Enhancement of gastrointestinal tract maturation has been proposed as a function of erythropoietin in breastmilk.[2,3]

Effects on Lactation and Breastmilk

In small studies, epoetin alfa administration decreased serum prolactin in patients with amyotrophic lateral sclerosis,[4] but had no effect in normal subjects or in patients with renal failure undergoing chronic ambulatory peritoneal dialysis.[5,6] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Epoetin Alfa

References

1.

Untalan PB, Keeney SE, Palkowetz KH, et al. Heat susceptibility of interleukin-10 and other cytokines in donor human milk. Breastfeed Med. 2009;4:137–44. [PubMed: 19366315]

2.

Miller M, Iliff P, Stoltzfus RJ, et al. Breastmilk erythropoietin and mother-to-child HIV transmission through breastmilk. Lancet. 2002;360:1246–8. [PubMed: 12401271]

3.

Semba RD, Juul SE. Erythropoietin in human milk: Physiology and role in infant health. J Hum Lact. 2002;18:252–61. [PubMed: 12192960]

4.

Tokgöz B, Utas C, Dogukan A, et al. Influence of long term erythropoietin therapy on the hypothalamic-pituitary-thyroid axis in patients undergoing CAPD. Ren Fail. 2002;24:315–23. [PubMed: 12166698]

5.

Bernini GP, Mariotti F, Brogi G, et al. Effects of erythropoietin administration on prolactin secretion in normal subjects. Nephron. 1993;65:522–6. [PubMed: 8302403]

6.

Markianos M, Kosmidis ML, Sfagos C. Reductions in plasma prolactin during acute erythropoietin administration. Neuro Endocrinol Lett. 2006;27:355–8. [PubMed: 16816832]

Substance Name

Epoetin Beta

CAS Registry Number

677324-53-7

Drug Class

Breast Feeding

Lactation

Colony-Stimulating Factors

Hematinics

Hematopoietic Cell Growth Factors