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Daptomycin Pregnancy and Breastfeeding Warnings

Daptomycin is also known as: Cubicin

Daptomycin Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

Daptomycin Breastfeeding Warnings

In a case study, a nursing mother received 6.7 mg/kg IV once a day for 28 days. Samples of breast milk were collected over a 24-hour period (six 4-hour intervals) on day 27. The highest drug level measured in breast milk was 44.7 ng/mL (in the second sample). The calculated maximum daily dose to the infant (assuming mean milk consumption of 150 mL/kg/day) was 0.1% of the maternal dose. No side effects were observed in the nursing infant during the 28 days of maternal therapy or at follow-up.

LactMed: No special precautions needed. -AU, UK: Breastfeeding is not recommended during use of this drug. -US: Caution is recommended. Excreted into human milk: Yes (low levels) Comments: -Due to the large molecular weight of this drug (1620.67 daltons) and high protein binding (90% to 93%), amount of drug exposure for a nursing infant appears very low; poor oral bioavailability further reduces systemic exposure for the nursing infant. -This drug is not expected to harm a nursing infant.

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