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Pregnant Women: URECE should be administered to women who are or may be pregnant only if the expected therapeutic benefits outweigh the possible risks associated with treatment. Skeletal variations were observed at doses equivalent to approximately 1053 and 174 times the clinical exposure in animal studies (rats and rabbits).
Breast-feeding Women: Continuation or discontinuation of breast-feeding should be considered in view of the therapeutic benefits and the benefits of breast-feeding. It has been reported in animal studies (rats) that dotinurad was excreted in breast milk.
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