Use in Pregnancy: As for other drugs that also act directly on the RAAS, Entresto must not be used during pregnancy (see Contraindications). Entresto exerts its effects via angiotensin II antagonism. As a result, a risk to the fetus cannot be excluded. There have been reports of injury to the developing fetus (e.g. spontaneous abortion, oligohydramnios and newborn renal dysfunction), when pregnant women have taken valsartan. Patients should be advised to discontinue Entresto as soon as pregnancies occur and to inform their physicians.
Use in Lactation: It is not known whether Entresto is excreted in human milk. The components of Entresto, sacubitril and valsartan were excreted in the milk of lactating rats (see Pharmacology: Toxicology: Non-Clinical Safety Data under Actions). Because of the potential risk for adverse drug reactions in breastfed newborns/infants, Entresto is not recommended during breastfeeding. A decision should be made whether to abstain from breast-feeding or to discontinue Entresto while breast-feeding, taking into account the importance of Entresto to the mother.