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Pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies of SIVEXTRO in pregnant women. SIVEXTRO should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In embryo-fetal studies, tedizolid phosphate was shown to produce fetal developmental toxicities in mice, rats, and rabbits. Fetal developmental effects occurring in mice in the absence of maternal toxicity included reduced fetal weights and an increased incidence of costal cartilage anomalies at the high dose of 25 mg/kg/day (4-fold the estimated human exposure level based on AUCs). In rats, decreased fetal weights and increased skeletal variations including reduced ossification of the sternebrae, vertebrae, and skull were observed at the high dose of 15 mg/kg/day (6-fold the estimated human exposure based on AUCs) and were associated with maternal toxicity (reduced maternal body weights). In rabbits, reduced fetal weights but no malformations or variations were observed at doses associated with maternal toxicity. The no observed adverse effect levels (NOAELs) for fetal toxicity in mice (5 mg/kg/day), maternal and fetal toxicity in rats (2.5 mg/kg/day), and rabbits (1 mg/kg/day) were associated with tedizolid plasma area under the curve (AUC) values approximately equivalent to (mice and rats) or 0.04-fold (rabbit) the tedizolid AUC value associated with the oral human therapeutic dose.
In a pre-postnatal study, there were no adverse maternal or offspring effects when female rats were treated during pregnancy and lactation with tedizolid phosphate at the highest tested dose of 3.75 mg/kg/day, with plasma tedizolid exposure (AUC) approximately equivalent to the human plasma AUC exposure at the clinical dose of 200 mg/day.
Nursing Mothers: Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SIVEXTRO is administered to a nursing woman.
