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Pregnancy: There are no data from the use of Vericiguat (Verquvo) in pregnant women. Given the potential for mechanism-based hemodynamic effects, Vericiguat (Verquvo) is not recommended during pregnancy and in women of childbearing potential not using contraception. Developmental toxicity studies in rats and rabbits with vericiguat administered orally during organogenesis showed no developmental toxicity up to 75 or 27 times, respectively, the human exposure (unbound AUC) at the maximum recommended human dose (MRHD) of 10 mg. Exaggerated pharmacodynamic-mediated maternal toxicity was observed in rats and rabbits at ≥21 and ≥6 times, respectively, the human exposure at the MRHD resulting in secondary late spontaneous abortions and resorptions in rabbits. There was no maternal toxicity in rats at 9 times the human exposure at the MRHD, and no maternal toxicity or abortions/resorptions in rabbits at an exposure equivalent to the human exposure at the MRHD. In a pre/postnatal toxicity study, vericiguat administered orally to rats during gestation through lactation showed exaggerated pharmacodynamic-mediated maternal toxicity at approximately ≥9 times the human exposure at the MRHD, which resulted in decreased pup body weight gain (≥21 times the MRHD) and pup mortality (49 times the MRHD) during the preweaning period.
Nursing Mothers: There is no information regarding the presence of vericiguat in human milk, the effects on the breast-fed infant, or the effects on milk production. Vericiguat is present in the milk of lactating rats. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Vericiguat (Verquvo) therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
