<p>There are no available data on Ferric Derisomaltose use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Published studies on the use of intravenous iron products in pregnant women have not reported an association with adverse developmental outcomes. However, these studies cannot establish or exclude the absence of any drug-related risk during pregnancy because the studies were not designed to assess for the risk of major birth defects.<br />
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The available data on the use of Ferric Derisomaltose in lactating women demonstrate that iron is present in breast milk. However, the data do not inform the potential exposure of iron for the breastfed child or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother&rsquo;s clinical need for Ferric Derisomaltose in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.</p>