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Pregnancy: There are no data from the use of sodium zirconium cyclosilicate in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of Lokelma during pregnancy.
Breast-feeding: In a postnatal study in rats, maternal exposure to sodium zirconium cyclosilicate had no effect on postnatal development. Due to its physicochemical properties, sodium zirconium cyclosilicate is not systemically absorbed and is not expected to be excreted in breast milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to sodium zirconium cyclosilicate is negligible. Lokelma can be used during breast-feeding.
Fertility: No human data on the effect of sodium zirconium cyclosilicate on fertility are available. In rats, there was no effect on fertility with sodium zirconium cyclosilicate treatment.
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