Epoetin Alfa use while Breastfeeding

Drugs containing Epoetin Alfa: Procrit, Epogen

Epoetin Alfa Levels and Effects while Breastfeeding

Summary of Use during Lactation

Erythropoietin is a normal component of human milk. The excretion of exogenous epoetin alfa (recombinant human erythropoietin; EPO) in breastmilk has not been studied. Although some studies have shown an improve response of postpartum anemia when EPO was used with iron therapy, current consensus is that EPO has no clinically important effect on the increase in hemoglobin concentration over iron alone.[1] No adverse reactions were reported in the breastfed infants of mothers who received EPO. No special precautions are required during breastfeeding if mothers receive EPO.[2]

Some authors have hypothesized that erythropoietin in milk might help maintain the integrity of the lining of the mammary epithelium and the infant gastrointestinal tract, thereby reducing the risk of mother-to-child transmission of HIV infection (MTCT).[3] A case-control study in Tanzania supports the protective role of erythropoietin in breastmilk against MTCT.[4] Erythropoietin might also have a modest beneficial effect on the infant's red cell production.[5] Holder pasteurization (62.5 degrees C for 30 minutes) decreases the concentration of endogenous erythropoietin by an average about 75%, with complete degradation in some samples.[6]

Drug Levels

Maternal Levels. Relevant published information on exogenous administration of epoetin alfa 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.[3] A study on pasteurization of breastmilk found that the erythropoietin concentration in breastmilk dropped from 1.9 international units/L before pasteurization to 0.5 international units/L after pasteurization.[7]

Infant Levels. Published information on absorption of epoetin 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.[5][8][9][10][11][12] 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.[13]

Effects in Breastfed Infants

Enhancement of gastrointestinal tract maturation has been proposed as a function of erythropoietin in breastmilk.[3][13]

In a study of 40 women with postpartum anemia, 19 of 20 women who received iron and subcutaneous recombinant human erythropoietin (EPO; generic name and brand not specified) 200 IU/kg daily for 15 days were able to breastfeed their infants. This regimen is more aggressive than the approve three times/week regimen. In the control group that received only oral iron and folic acid, only 10 were able to breastfeed their infants. No adverse reactions were reported among the infants of women who receive EPO.[2]

Possible Effects on Lactation

In small studies, epoetin alfa administration decreased serum prolactin in patients with amylotrophic lateral sclerosis,[14] but had no effect in normal subjects or in patients with renal failure undergoing chronic ambulatory peritoneal dialysis.[15][16] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

References

1. Milman N. Postpartum anemia II: prevention and treatment. Ann Hematol. 2012;91:143-54. PMID: 22160256

2. Makrydimas G, Lolis D, Lialios G et al. Recombinant human erythropoietin treatment of postpartum anemia. Preliminary results. Eur J Obstet Gynecol Reprod Biol. 1998;81:27-31. PMID: 9846709

3. Semba RD, Juul SE. Erythropoietin in human milk: physiology and role in infant health. J Hum Lact. 2002;18:252-61. PMID: 12192960

4. Arsenault JE, Webb AL, Koulinska IN et al. Association between breast milk erythropoietin and reduced risk of mother-to-child transmission of HIV. J Infect Dis. 2010;202:370-3. PMID: 20557236

5. Pasha YZ, Ahmadpolir-Kacho M, Hajiahmadi M, Hosseini M. Enteral erythropoietin increases plasma erythropoietin level in preterm infants: a randomized controlled trial. Indian Pediatr. 2008;45:25-8. PMID: 18250501

6. 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. PMID: 19366315

7. Untalan PB, Keeney SE, Rivera A, Goldman AS. The effect of pasteurization on cytokines in human milk. J Invest Med. 2007;55 (Suppl S):S288. Abstract.

8. Calhoun DA, Christensen RD. 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. PMID: 15183665

9. Ballin A, Bilker-Reich A, Arbel E et al. Erythropoietin, given enterally, stimulates erythropoiesis in premature infants. Lancet. 1999;353:1849. Letter. PMID: 10359412

10. Juul SE. Enterally doses recombinant human erythropoietin does not stimulate erythropoiesis in neonates. J Pediatr. 2003;143:321-6. PMID: 14517513

11. Juul SE, Cristensen RD. Absorption of enteral recombinant human erythropoietin by neonates. Ann Pharmacother. 2003;37:782-6. PMID: 12773061

12. Britton JR, Christensen RD. Enteral administration of recombinant erythropoietin to preterm infants. J Perinatol. 1995;15:281-3. PMID: 8558334

13. Miller M, Iliff P, Stoltzfus RJ, Humphrey J. Breastmilk erythropoietin and mother-to-child HIV transmission through breastmilk. Lancet. 2002;360:1246-8. PMID: 12401271

14. Tokgoz 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. PMID: 12166698

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

16. Markianos M, Kosmidis ML, Sfagos C. Reductions in plasma prolactin during acute erythropoietin administration. Neuro Endocrinol Lett. 2006;27:355-8. PMID: 16816832

Epoetin Alfa Identification

Substance Name

Epoetin Alfa

CAS Registry Number

113427-24-0

Drug Class

  • Colony-Stimulating Factors
  • Hematinics
  • Hematopoietic Cell Growth Factors

Administrative Information

LactMed Record Number

496

Information from the National Library of Medicine's LactMed Database.

Last Revision Date

2013-09-07

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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