Epoetin alfa Pregnancy and Breastfeeding Warnings
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.
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.
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