Entresto

Entresto Use In Pregnancy & Lactation

sacubitril + valsartan

Manufacturer:

Novartis

Distributor:

Zuellig
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Use In Pregnancy & Lactation
Use in Pregnancy: The use of Entresto is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy (see Contraindications).
Valsartan: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however, a small increase in risk cannot be excluded. Whilst there is no controlled epidemiological data on the risk with ARBs, similar risks may exist for this class of medicinal product. Unless continued ARB therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ARBs should be stopped immediately and, if appropriate, alternative therapy should be started. Exposure to ARBs therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Should exposure to ARBs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ARBs should be closely observed for hypotension (see Contraindications).
Sacubitril: There are no data from the use of sacubitril in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology under Actions).
Entresto: There are no data from the use of Entresto in pregnant women. Animal studies with Entresto have shown reproductive toxicity (see Pharmacology: Toxicology under Actions).
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 under Actions). Because of the potential risk for adverse reactions in breast-fed newborns/infants, it is not recommended during breast-feeding. 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.
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