Antibiotic (Cephalosporin)
PREGNANCY RECOMMENDATION: Compatible
BREASTFEEDING RECOMMENDATION: Compatible
PREGNANCY SUMMARY
No reports describing the use of ceftaroline fosamil in human pregnancy have been located. Animal data suggest low risk. Although there is no human pregnancy experience, in general, cephalosporins are considered compatible in pregnancy.
FETAL RISK SUMMARY
Ceftaroline fosamil is a cephalosporin antibiotic that is converted to the bioactive ceftaroline after IV administration. It is indicated for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Plasma protein binding is about 20% and the elimination half-life after multiple doses is about 2.7 hours (1).
Reproduction studies have been conducted in rats and rabbits. In rats, doses that produced exposures that were about 8 times the human exposure from 600 mg every 12 hours based on AUC (HE) did not cause maternal toxicity or fetal harm. Moreover, a higher dose in rats revealed no evidence of an effect on postnatal development or reproductive performance in offspring. In rabbits, doses that were about 0.8 times the HE or higher were maternal toxic but did not cause malformations (1).
Ceftaroline fosamil was not mutagenic in multiple assays but was clastogenic in an in vitro assay. The latter effect was not observed after metabolic activation. No evidence of impaired fertility was observed in male and female rats at doses up to about 4 times the maximum recommended human dose based on BSA (1).
It is not known if ceftaroline fosamil or ceftaroline crosses the human placenta. The molecular weight of the prodrug (about 685) and lower molecular weight of the active agent, and the elimination half-life and low plasma protein binding, suggest that ceftaroline will cross to the embryo–fetus.
BREASTFEEDING SUMMARY
No reports describing the use of ceftaroline fosamil during human lactation have been located. The molecular weight of the prodrug (about 685) and lower molecular weight of the active agent, and the elimination half-life (about 2.7 hours) and low plasma protein binding (about 20%), suggest that both the prodrug and active agent will be excreted into breast milk. Moreover, low concentrations of other cephalosporins are excreted into milk and the presence in milk of this antibiotic should be expected. Three potential problems exist for the nursing infant: modification of bowel flora, direct effects on the infant, and interference with the interpretation of culture results if a fever workup is required. The American Academy of Pediatrics classifies other cephalosporin antibiotics as compatible with breastfeeding (for example, see Cefadroxil and Cefazolin).
Reference
1.Product information. Teflaro. Forest Pharmaceuticals, 2011.