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Daptomycin Pregnancy and Breastfeeding Warnings

Daptomycin is also known as: Cubicin, Cubicin RF

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: Not assigned. Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

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 5th sample (ended 20 hours after dosing) contained 29.2 ng/mL; the final sample had no detectable drug (less than 25 ng/mL). 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. -According to some authorities: Breastfeeding is not recommended during use of this drug. Excreted into human milk: Yes (low levels) Comments: -Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug. -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; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

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References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Cubicin (daptomycin)." Cubist Pharmaceuticals Inc, Lexington, MA.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Cubicin (daptomycin)." Cubist Pharmaceuticals Inc, Lexington, MA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Buitrago MI, Crompton JA, Bertolami S, North DS, Nathan RA "Extremely low excretion of daptomycin into breast milk of a nursing mother with methicillin-resistant staphylococcus aureus pelvic inflammatory disease." Pharmacotherapy 29 (2009): 347-51

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