Bedapt Daptomycin Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are no adequate and well-controlled studies of Daptomycin for injection in pregnant women. Daptomycin for injection should be used during pregnancy only if the potential benefit outweighs the possible risk.
Embryofetal development studies performed in rats and rabbits at doses of up to 75 mg/kg (approximately 2 and 4 times the recommended 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. Because animal reproduction studies are not always predictive of human response, Daptomycin for injection should be used during pregnancy only if the expected benefit outweighs the possible risk.
Nursing Mothers: Excretion of daptomycin into milk of lactating animals has not been studied. In a single human case study, Daptomycin for injection 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 Daptomycin for injection.