Ambigrast Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C: Rhg-CSF 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 rhG-CSF at 80 mcg/kg body weight/day. RhG-CSF 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 rhG-CSF was not associated with lethal, teratogenic, or behavioral effects on fetuses when administered by daily IV injections 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.
Use in Lactation: it is not known whether rhG-CSF is excreted in human milk. Because many drugs are excreted in human milk, rhG-CSF is not recommended for use in breastfeeding women.