Pregnancy There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes in pregnant women Animal data In animal studies, drug caused embryofetal toxicity, including increased resorptions, increased peri-implantation loss, and incomplete ossification at multiple fetal sites when administered intravenously to pregnant rats and rabbits during organogenesis at doses up to 0.8 and 2 times the clinical dose, respectively; advise patients of potential risk to fetus; estimated background risk of major birth defects and miscarriage for indicated population is unknown; all pregnancies have a background risk of...
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