The Basics
What is Darbepoetin?
Used to treat anemia in people with chronic kidney failure.
Brand names for Darbepoetin
Aranesp
How Darbepoetin is classified
Colony-Stimulating Factors, Hematinics, Hematopoietic Cell Growth Factors
Darbepoetin During Pregnancy
Darbepoetin 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 Darbepoetin while pregnant
The limited available data on Aranesp use in pregnant women are insufficient to determine a drug-associated risk of major birth defects or miscarriage. In animal reproductive and developmental toxicity studies, Aranesp increased early post-implantation loss at doses approximating the clinical recommended starting doses (see Data). Consider the benefits and risks of Aranesp for the mother and possible risks to the fetus when prescribing Aranesp 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 Darbepoetin While Breastfeeding
What are recommendations for lactation if you're taking Darbepoetin?
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.
Maternal / infant drug levels
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.
Possible effects of Darbepoetin on milk supply
In small studies, epoetin alfa administration decreased serum prolactin in patients with amylotrophic lateral sclerosis,[9] but had no effect in normal subjects or in patients with renal failure undergoing chronic ambulatory peritoneal dialysis.[10][11] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.
Possible alternatives to Darbepoetin
Epoetin alfa.
List of References
Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Semba RD, Juul SE. Erythropoietin in human milk: physiology and role in infant health. J Hum Lact. 2002;18:252-61. PMID: 12192960
2. 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
3. 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
4. Ballin A, Bilker-Reich A, Arbel E et al. Erythropoietin, given enterally, stimulates erythropoiesis in premature infants. Lancet. 1999;353:1849. Letter. PMID: 10359412
5. Juul SE. Enterally doses recombinant human erythropoietin does not stimulate erythropoiesis in neonates. J Pediatr. 2003;143:321-6. PMID: 14517513
6. Juul SE, Cristensen RD. Absorption of enteral recombinant human erythropoietin by neonates. Ann Pharmacother. 2003;37:782-6. PMID: 12773061
7. Britton JR, Christensen RD. Enteral administration of recombinant erythropoietin to preterm infants. J Perinatol. 1995;15:281-3. PMID: 8558334
8. 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
9. 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
10. 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
11. Markianos M, Kosmidis ML, Sfagos C. Reductions in plasma prolactin during acute erythropoietin administration. Neuro Endocrinol Lett. 2006;27:355-8. PMID: 16816832
Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.
