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Characterization of the Penetration of Garenoxacin into the Breast Milk of Lactating Women

From the Clinical Pharmacology Research Center, Department of Adult and Pediatric Medicine, Bassett Healthcare, Cooperstown, New York (Dr. Amsden, Ms. Whitaker); Center for Anti-Infective Research and Development (Dr. Nicolau, Dr. Maglio) and Division of Infectious Diseases (Dr. Nicolau), Hartford Hospital, Hartford, Connecticut; and Pharmaceutical Research Institute, Bristol-Myers Squibb, Princeton, New Jersey (Dr. Bello, Dr. Russo, Mr. Barros, Dr. Gajjar).

The primary objective of this study was to characterize the extent of excretion of garenoxacin, a novel des-F(6)-quinolone antimicrobial, into the breast milk of lactating women. A secondary objective was to determine the time after dose administration that garenoxacin was no longer detected in breast milk so as to define when a mother may resume breastfeeding if it was interrupted for garenoxacin administration. Six healthy, lactating women (age [mean ± SD]: 32 ± 6 years; weight: 68.3 ± 19.8 kg; body mass index: 26 ± 5 kg/m²) who had completed weaning their infants were administered a single 600-mg oral dose of garenoxacin. Plasma samples were collected predose and repeatedly up to 72 hours postdose. Breast milk was collected predose and for 6- to 12-hour intervals repeatedly up to 120 hours postdose. Breast milk/plasma concentration ratios for garenoxacin ranged from 0.35 to 0.44 up to 24 hours postdose, and the mean peak breast milk concentration was 3.0 µg/mL (0- to 6-h collection interval). Overall, garenoxacin exposure in breast milk was minimal, with a mean of 0.07% of the administered dose recovered within 120 hours. Indeed, garenoxacin was undetectable in the breast milk of a majority of subjects within 84 hours of dosing. As such, an infant nursing from a mother who had received a single 600-mg oral dose of garenoxacin could theoretically be exposed to 0.42 mg of garenoxacin (0.105 mg/kg/day for a 4-kg infant over the period of 5 days of nursing). If extrapolated to a 14-day course of garenoxacin 600 mg once daily, total exposure would be approximately 5.88 mg. These findings indicate that, like other quinolone antimicrobials, garenoxacin is secreted in breast milk.

Key Words: Garenoxacin • breast milk • lactation • pediatrics • breastfeeding

Address for reprints: Guy W. Amsden, PharmD, FCP, Clinical Pharmacology Research Center, Bassett Healthcare, One Atwell Road, Cooperstown, NY 13326.

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