When filgrastim was first licensed, little information was available regarding placen-tal transfer of the protein. Since that time, two publications have addressed this issue, and filgrastim was shown to cross the placenta and specifically induce bone marrow and spleen myelopoiesis in the fetus and neonate in a preclinical rat study (15,16).

No well-controlled trials have been done to study the use of filgrastim in human pregnancies; however, the transplacental passage of a measurable amount of filgrastim in women who received a single dose of filgrastim and in whom preterm delivery was imminent was reported (17). Concentrations of G-CSF and neutrophils were measured in maternal blood and umbilical venous cord blood after administration of a single intravenous (iv) 25-^g/kg dose of filgrastim in 11 women in whom preterm delivery was imminent. These measurements were compared with values from 34 control women and 35 cord sera. The transplacental passage of a measurable quantity of filgrastim was noted, especially in those women who received filgrastim at least 30 h before delivery. According to the authors, this amount of filgrastim can have a biologic effect on the fetus.

0 0

Post a comment