NESP Use In Pregnancy & Lactation

Use in Pregnancy: Pregnancy Category: B3*.
*Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals have shown evidence of an increased occurrence of foetal damage, the significance of which is considered uncertain in humans.
Reproductive studies in rats showed no significant placental transfer of darbepoetin alfa. Studies in pregnant rats and rabbits showed no evidence of direct embryotoxic, foetotoxic or teratogenic properties of darbepoetin alfa at IV doses of up to 20 μg/kg/day. Systemic exposure (AUC/dose) at the highest dose was about 4 times (rats) and 20 times (rabbits) that in humans at the recommended initial SC dose of 2.25 μg/kg in cancer patients. Reductions in foetal weights were observed in both species and were probably associated with polycythaemia in the dams. Intravenous injection of darbepoetin alfa to female rats every other day from day 6 of gestation through day 23 of lactation at doses of 2.5 μg/kg/dose and higher resulted in offspring (F1 generation) with decreased body weights, which correlated with a low incidence of deaths, as well as delayed eye opening and delayed preputial separation. No adverse effects were seen in the F2 offspring.
No studies have been conducted in pregnant women. NESP should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Use in Lactation: It is not known whether darbepoetin alfa is excreted in human milk, although many drugs are excreted in human milk. In a reproductive study in rats, IV administration of darbepoetin alfa during gestation and lactation at doses of up to 10 μg/kg/day caused decreases in pup viability during lactation and delays in pup development, in addition to reductions in pup birth weights. Although these effects were probably due to polycythaemia and associated toxicity in the dams, caution should be exercised when NESP is administered to a breastfeeding woman.