Cubicin Use In Pregnancy & Lactation

Pregnancy and Lactation: Risk summary: Embryo/fetal development and teratology studies performed in rats and rabbits at doses of up to 75 mg/kg (2 and 4 times the 6 mg/kg human dose, respectively, on a body surface area basis) revealed no evidence of harm to the fetus due to daptomycin. Daptomycin can cross the placenta in pregnant rats. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, CUBICIN should be used during pregnancy only if the potential benefit outweighs the possible risk.
Excretion of daptomycin into milk of lactating animals has not been studied. In a single human case study, CUBICIN was administered daily for 28 days to a nursing mother at an IV dose of 6.7 mg/kg/day, and samples of the patient's breast milk were collected over a 24-hour period on day 27. The highest measured concentration of daptomycin in the breast milk was 0.045 μg/mL, which is a low concentration. Until more experience is gained, women should be instructed to avoid breast-feeding while receiving CUBICIN.