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No clinical studies have been conducted to date to evaluate vonoprazan in subjects who are pregnant or lactating. In a rat toxicology study, embryo-foetal toxicity was observed following exposure of more than approximately 28 times of the exposure (AUC) at the maximum clinical dose (40 mg/day) of vonoprazan. It is unknown whether vonoprazan is excreted in human milk. In animal studies it has been shown that vonoprazan was excreted in milk.
As a precaution, vonoprazan should not be administered to women who are or may be pregnant, unless the expected therapeutic benefit is thought to outweigh any possible risk.
During treatment with vonoprazan, nursing should be avoided if the administration of this drug is necessary for the mother.
