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Entresto

Entresto Use In Pregnancy & Lactation

sacubitril + valsartan

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Risk Summary: 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.
Animal Data: Entresto treatment during organogenesis resulted in increased embryo-fetal lethality in rats at doses ≥100 mg/kg/day [≤0.72 fold the maximum recommended human dose (MRHD) on the basis of AUC] and rabbits at doses ≥ 10 mg/kg/day [2 fold and 0.03 fold the MRHD on the basis of valsartan and sacubitrilat AUC, respectively]. Entresto is teratogenic based on a low incidence of fetal hydrocephaly, associated with maternally toxic doses, which was observed in rabbits at an Entresto dose of ≥ 10 mg/kg/day. The adverse embryo-fetal effects of Entresto are attributed to the angiotensin receptor antagonist activity.
Pre- and postnatal development studies in rats conducted with sacubitril at doses up to 750 mg/kg/day [2.2 fold the MRHD on the basis of AUC] and valsartan at doses up to 600 mg/kg/day [0.86 fold the MRHD on the basis of AUC] indicate that treatment with Entresto during organogenesis, gestation and lactation may affect pup development and survival.

Lactation: Risk Summary: It is not known whether the components of Entresto are transferred into human milk. The components of Entresto, sacubitril and valsartan were transferred into the milk of lactating rats. 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.
Females and males of reproductive potential: Females patients of child-bearing potential should be advised about the consequences of exposure to Entresto during pregnancy and to use contraception during treatment with Entresto and for 1 week after their last dose.
Infertility: There are no available data on the effect of Entresto on human fertility. Entresto did not show any effects on fertility or early embryonic development in rats up to a dose of 150 mg/kg/day (≤1.0 fold and ≤0.18 fold the MRHD on the basis of valsartan and sacubitrilat AUC, respectively).
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