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Epoetin alfa Pregnancy and Breastfeeding Warnings

Epoetin alfa is also known as: Epogen, Procrit

Epoetin alfa Pregnancy Warnings

Animal studies resulted in delayed weight gain, hair growth, eyelid opening, and skeletal ossification, or in abnormal vertebral development. Eleven women with normal renal function, hemoglobin less than 10 g/dL, and gestational age greater than 20 weeks received 300 units/kg intravenous epoetin alfa and intravenous iron once a week (up to 4 weeks) until a hemoglobin of 11 g/dL was reached. All women responded, however, an immediate response was noted in women with higher baseline ferritin values. A case report described a 29-year-old primigravida who developed hypoproliferative moderate anemia (hemoglobin of 8.5 g/L) without renal disease following the use of leuprolide acetate and menopausal gonadotropin (hMG) therapy. The serum erythropoietin level was 9 mmol/mL (normal is 10 to 30 mmol/mL). Epoetin alfa therapy, 100 units/kg subcutaneously three times a week, was initiated at 18 weeks. The dosage was adjusted to maintain a hemoglobin of 10.5 to 11.5 g/dL and administered 1 to 3 times a week. A healthy infant with normal hemoglobin levels and no evidence of fetal polycythemia was delivered. No intrauterine growth abnormalities or placental or amniotic fluid volume problems were noted.

Epoetin alfa has been assigned to pregnancy category C by the FDA. Animal studies using doses five times the recommended human dosage revealed adverse fetal effects. Human studies have shown a lack of placental transfer however, the effect of epoetin on placental function has not been determined. A pilot study involving anemic pregnant patients with normal renal function reported improved reticulocyte ratio and hemoglobin levels during epoetin therapy. Case reports have described the successful use of epoetin during pregnancy in patients without renal disease. Of concern with epoetin alfa is the ability to differentiate between epoetin alfa associated hypertension and that of preeclampsia. Epoetin alfa is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

See references

Epoetin alfa Breastfeeding Warnings

There are no data on the excretion of epoetin alfa into human milk. The manufacturer recommends that caution be used when administering epoetin alfa to nursing women.

See references

References for pregnancy information

  1. Scott LL, Ramin SM, Richey M, Hanson J, Gilstrap LC "Erythropoietin use in pregnancy: two cases and a review of the literature." Am J Perinatol 12 (1995): 22-4
  2. "Product Information. Epogen (epoetin alfa)." Amgen, Thousand Oaks, CA.
  3. Huch R, Huch A "Erythropoietin in obstetrics." Hematol Oncol Clin North Am 8 (1994): 1021
  4. Breymann C, Major A, Richter C, Huch R, Huch A "Recombinant human erythropoietin and parenteral iron in the treatment of pregnancy anemia: a pilot study." J Perinat Med 23 (1995): 89-98
  5. Yankowitz J, Piraino B, Laifer SA, Frassetto L, Gavin L, Kitzmiller JL, Crombleholme W "Erythropoietin in pregnancies complicated by severe anemia of renal failure." Obstet Gynecol 80 (1992): 485-8
  6. Amoedo ML, Fernandez E, Borras M, Pais B, Montoliu J "Successful pregnancy in a hemodialysis patient treated with erythropoietin." Nephron 70 (1995): 262-3
  7. Sungur C, Arik N, Yasavul U, Turgan C, Caglar S "Decreased response to human recombinant erythropoietin therapy in pregnancy ." Am J Nephrol 12 (1992): 390
  8. Hou S, Orlowski J, Pahl M, Ambrose S, Hussey M, Wong D "Pregnancy in women with end-stage renal disease: treatment of anemia and premature labor." Am J Kidney Dis 21 (1993): 16-22
  9. Harris SA, Payne G, Putman JM "Erythropoietin treatment of erythropoietin-deficient anemia without renal disease during pregnancy." Obstet Gynecol 87 (1996): 812-4
  10. Junca J, Vela D, Orts M, Riutort N, Feliu E "Treating the anaemia of a pregnancy with heterozygous beta thalassaemia with recombinant human erythropoietin (r-huEPO)." Eur J Haematol 55 (1995): 277-8
  11. "Product Information. Procrit (epoetin alfa)." Ortho Biotech Inc, Raritan, NJ.

References for breastfeeding information

  1. "Product Information. Epogen (epoetin alfa)." Amgen, Thousand Oaks, CA.
  2. "Product Information. Procrit (epoetin alfa)." Ortho Biotech Inc, Raritan, NJ.

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