Gadofosveset trisodium has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Gadofosveset trisodium is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk.

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There are no data on the excretion of gadofosveset trisodium into human milk. The effects in the nursing infant are unknown. The manufacturer recommends that caution be used when administering gadofosveset trisodium to nursing women.

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