Sybrava Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of inclisiran in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions). As a precautionary measure, it is preferable to avoid the use of inclisiran during pregnancy.
Breast-feeding: It is unknown whether inclisiran is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of inclisiran in milk (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from inclisiran therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No data on the effect of inclisiran on human fertility are available. Animal studies did not show any effects on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).