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Pregnancy: There are insufficient human data regarding the use of Tolvaptan in pregnant women to determine the risk of adverse developmental outcomes; however, Tolvaptan use during pregnancy may cause fetal harm. Advise pregnant women of the potential for fetal harm if Tolvaptan is used during pregnancy. Administer Tolvaptan during pregnancy only if the potential maternal benefit outweighs the potential fetal risk.
Lactation: It is unknown whether Tolvaptan is present in human milk, effects milk production, or impacts the breastfed infant. Due to the risk of serious adverse effects to the infant, including hepatotoxicity, hypernatremia, hypotension, and volume depletion, advise women to avoid breastfeeding during Tolvaptan therapy.
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