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Pregnant Women: Clinical trials with roxadustat have not been conducted in pregnant women. Reproductive toxicity studies in animals demonstrated roxadustat can reduce foetal and pup body weight. Therefore, roxadustat is contraindicated in pregnant women. Women of childbearing age should use highly effective contraceptive methods during treatment and for 7 days after the last dose.
Lactating Women: It is currently unknown whether roxadustat is excreted in human milk. A study in rats has shown excretion of roxadustat in milk, potentially leading to increased mortality, slowed growth, and delayed development in offspring. Consequently, roxadustat is contraindicated in lactating women.
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