Uperio Use In Pregnancy & Lactation

Females of child-bearing potential (and contraceptive measures if applicable): Female patients of child-bearing potential should be advised about the consequences of exposure to UPERIO during pregnancy and to use contraception during treatment with UPERIO and for 1 week after their last dose. Pregnancy: As for other drugs that also act directly on the RAAS, UPERIO must not be used during pregnancy (see Contraindications). UPERIO 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 UPERIO as soon as pregnancies occur and to inform their physicians.
Breast-feeding: It is not known whether UPERIO is excreted in human milk. The components of UPERIO, 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, UPERIO is not recommended during breastfeeding. A decision should be made whether to abstain from breast-feeding or to discontinue UPERIO while breast-feeding, taking into account the importance of UPERIO to the mother.
Fertility: There are no available data on the effect of UPERIO on human fertility. No impairment of fertility was demonstrated in studies with UPERIO in male and female rats (see Pharmacology: Toxicology: Non-clinical safety data under Actions).