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Pregnancy: There are no data from the use of difelikefalin 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 KORSUVA during pregnancy.
Breast-feeding: It is unknown whether difelikefalin is excreted in human breast milk.
A risk to the newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from KORSUVA therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Animal studies have shown excretion of difelikefalin in breast milk.
Fertility: There are no data on the effect of difelikefalin on fertility in humans. In rat studies with difelikefalin, there was no effect on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).
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