Neocyte Use In Pregnancy & Lactation

Pregnancy: Category C.
Filgrastim has been shown to have adverse effects in pregnant rabbits when given in doses 2 to 10 times the human dose.
In rabbits, increased abortion and embryolethality were observed in animals treated with filgrastim at 80 mcg/kg body weight/day. Filgrastim administered to pregnant rabbits at doses of 80 mcg/kg body weight/day during the period of organogenesis was associated with increased fetal resorption, genitourinary bleeding, developmental abnormalities, decreased body weight, live births, and food consumption. External abnormalities were not observed in the fetuses of dams treated at 80 mcg/kg body weight/day. Reproductive studies in pregnant rats have shown that filgrastim was not associated with lethal, teratogenic, or behavioral effects on fetuses when administered by daily IV injection during the period of organogenesis at dose levels up to 575 mcg/kg body weight/day.
In rats, offspring of dams treated at >20 mcg/kg body weight/day exhibited a delay in external differentiation (detachment of auricles and descent of testes) and slight growth retardation, possibly due to lower body weight of females during rearing and nursing. Offspring of dams treated at 100 mcg/kg body weight/day exhibited decreased body weights at birth, and a slightly reduced 4-day survival rate.
There are cases in literature where the transplacental passage of filgrastim has been demonstrated. Filgrastim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breastfeeding: It is not known whether filgrastim is excreted in human milk. Because many drugs are excreted in human milk, filgrastim is not recommended for use in breastfeeding women.