Repatha

Repatha Use In Pregnancy & Lactation

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: There are no or limited amount of data from the use of Repatha in pregnant women.
Animal studies do not indicate direct or indirect effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab.
Breast-feeding: It is unknown whether evolocumab is excreted in human milk.
A risk to breastfed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Repatha 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 evolocumab on human fertility are available. Animal studies did not show any effects on fertility endpoints at area under the concentration time curve (AUC) exposure levels much higher than in patients receiving evolocumab at 420 mg once monthly (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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