Use in Pregnancy: Pregnancy Category C: Recombinant G-CSF has been shown to have adverse effects in pregnant rabbits when given in doses 2 to 10 times the human dose. Since there are no adequate and well-controlled studies in pregnant women, the effect, if any, of Recombinant G-CSF on the developing fetus or the reproductive capacity of the mother is unknown. However, the scientific literature describes transplacental passage of Recombinant G-CSF when administered to pregnant rats during the latter part of gestation and apparent transplacental passage of Recombinant G-CSF when administered to pregnant humans by < 30 hours prior to preterm delivery (< 30 weeks gestation). Recombinant G-CSF should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in Lactation: It is not known whether Recombinant G-CSF is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Recombinant G-CSF is administered to a nursing woman.