Darbepoetin and Breastfeeding

Summary of use during lactation

The excretion of darbepoetin alfa in breastmilk or its effects on breastfed infants have not been studied. However, erythropoietin is a normal component of human milk and darbepoetin is immunologically and biologically indistinguishable from native erythropoietin. Intravenous darbepoetin has been given safely to newborn infants in doses much larger than those expected to appear in breastmilk. No special precautions are required during breastfeeding.

Drug levels in milk and infant serum

Maternal Levels. Relevant published information on exogenous administration of darbepoetin alfa to nursing mothers was not found as of the revision date. However, breastmilk normally contains erythropoietin.[1] Infant Levels. Published information on absorption of darbepoetin alfa from breastmilk was not found as of the revision date. However, several studies in which oral doses of epoetin alfa and other recombinant forms of erythropoietin were given to preterm infants found that epoetin is absorbed to a small extent. Increases in hematocrit in infants treated with oral epoetin alfa have been small to negligible.[2-7] However, one study found that hospitalized preterm infants taking enteral feedings and given 400 units daily of recombinant human erythropoietin by mouth with ferrous sulfate had higher reticulocyte counts and serum erythropoietin concentrations upon hospital discharge than control infants given only ferrous sulfate.[8]

Effects in breastfed infants

Enhancement of gastrointestinal tract maturation has been proposed as a function of erythropoietin in breastmilk.[1,8]

Effects on lactation and breastmilk

In small studies, epoetin alfa administration decreased serum prolactin in patients with amyotrophic lateral sclerosis, but had no effect in normal subjects or in patients with renal failure undergoing chronic ambulatory peritoneal dialysis.[9-11] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternative drugs to consider

Epoetin Alfa

References

1. SembaRD JuulSE Erythropoietin in human milk: Physiology and role in infant health. J Hum Lact 2002 18 252 61 12192960 PubMed
2. PashaYZ Ahmadpolir-KachoM HajiahmadiM Enteral erythropoietin increases plasma erythropoietin level in preterm infants: A randomized controlled trial. Indian Pediatr 2008 45 25 8 18250501 PubMed
3. CalhounDA ChristensenRD Hematopoietic growth factors in neonatal medicine: The use of enterally administered hematopoietic growth factors in the neonatal intensive care unit. Clin Perinatol 2004 31 169 82 15183665 PubMed
4. BallinA Bilker-ReichA ArbelE Erythropoietin, given enterally, stimulates erythropoiesis in premature infants. Lancet 1999 353 1849 10359412 PubMed
5. JuulSE Enterally dosed recombinant human erythropoietin does not stimulate erythropoiesis in neonates. J Pediatr 2003 143 321 6 14517513 PubMed
6. JuulSE ChristensenRD Absorption of enteral recombinant human erythropoietin by neonates. Ann Pharmacother 2003 37 782 6 12773061 PubMed
7. BrittonJR ChristensenRD Enteral administration of recombinant erythropoietin to preterm infants. J Perinatol 1995 15 281 3 8558334 PubMed
8. MillerM IliffP StoltzfusRJ Breastmilk erythropoietin and mother-to-child HIV transmission through breastmilk. Lancet 2002 360 1246 8 12401271 PubMed
9. TokgözB UtasC DogukanA Influence of long term erythropoietin therapy on the hypothalamic-pituitary-thyroid axis in patients undergoing CAPD. Ren Fail 2002 24 315 23 12166698 PubMed
10. BerniniGP MariottiF BrogiG Effects of erythropoietin administration on prolactin secretion in normal subjects. Nephron 1993 65 522 6 8302403 PubMed
11. MarkianosM KosmidisML SfagosC Reductions in plasma prolactin during acute erythropoietin administration. Neuro Endocrinol Lett 2006 27 355 8 16816832 PubMed