Epoetin Alfa

The Basics

What is Epoetin Alfa?

Used to treat anemia in people with chronic kidney failure.

Brand names for Epoetin Alfa

Epogen

How Epoetin Alfa is classified

Colony-Stimulating Factors, Hematinics, Hematopoietic Cell Growth Factors

Epoetin Alfa During Pregnancy

Epoetin Alfa pregnancy category

Category CNote 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 Epoetin Alfa while pregnant

Epogen from multiple-dose vials contains benzyl alcohol and is contraindicated in pregnant women . When therapy with Epogen is needed during pregnancy, use a benzyl alcohol-free formulation (i.e., single-dose vial). Do not mix Epogen with bacteriostatic saline when administering to pregnant women because it contains benzyl alcohol (see Clinical Considerations) . The limited available data on Epogen use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproductive and developmental toxicity studies, adverse fetal effects including embryo-fetal death, skeletal anomalies, and growth defects occurred when pregnant rats received epoetin alfa at doses approximating the clinical recommended starting doses (see Data). Consider the benefits and risks of Epogen single-dose vials for the mother and possible risks to the fetus when prescribing Epogen to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population 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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Taking Epoetin Alfa While Breastfeeding

What are recommendations for lactation if you're taking Epoetin Alfa?

The excretion of exogenous epoetin alfa (recombinant human erythropoietin; EPO) in breastmilk has not been studied. Erythropoietin is a normal component of human milk. Although some studies have shown an improve response of postpartum anemia when epoetin alfa was used with iron therapy, current consensus is that epoetin alfa 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 epoetin alfa. Based on theoretical considerations, the manufacturer recommends avoiding the use of epoetin alfa multiple-dose vials for lactating women because of its benzyl alcohol content and to avoid breastfeeding for 2 weeks after a dose that contains benzyl alcohol. No special precautions are required during breastfeeding if mothers receive epoetin alfa from a single-use vial without preservatives.[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] 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.[6]

Maternal / infant drug levels

The excretion of exogenous epoetin alfa (recombinant human erythropoietin; EPO) in breastmilk has not been studied. Erythropoietin is a normal component of human milk. Although some studies have shown an improve response of postpartum anemia when epoetin alfa was used with iron therapy, current consensus is that epoetin alfa 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 epoetin alfa. Based on theoretical considerations, the manufacturer recommends avoiding the use of epoetin alfa multiple-dose vials for lactating women because of its benzyl alcohol content and to avoid breastfeeding for 2 weeks after a dose that contains benzyl alcohol. No special precautions are required during breastfeeding if mothers receive epoetin alfa from a single-use vial without preservatives.[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] 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.[6]

Possible effects of Epoetin Alfa on milk supply

In small studies, epoetin alfa administration decreased serum prolactin in patients with amylotrophic lateral sclerosis,[13] but had no effect in normal subjects or in patients with renal failure undergoing chronic ambulatory peritoneal dialysis.[14][15] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Possible alternatives to Epoetin Alfa

None listed