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Pregnant Women: No clinical studies have been conducted to date to evaluate vonoprazan in subjects who are pregnant or lactating. This drug should be used in pregnant women or women having possibilities of being pregnant only if the expected therapeutic benefit is thought to outweigh any possible risk. In animal studies (rats), following exposure of more than approximately 28 times of the exposure (AUC) at the maximum clinical dose (40 mg/day) of vonoprazan, low values of fetal weight and placental weight, external abnormalities (anal stenosis and tail abnormalities) and visceral abnormalities (membranous ventricular septal defect and aberrant subclavian artery) were observed.
Breast-feeding Women: The continuation or discontinuation of breastfeeding should be considered while taking account of the expected therapeutic benefits of this drug and the benefits of maternal feeding. It has been reported in animal studies (rats) that vonoprazan is transferred to breast milk.
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