Fabhalta Use In Pregnancy & Lactation

Pregnancy: There are no or limited amount of data from the use of iptacopan in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at exposures between 2- and 8-fold the human exposure at the maximum recommended human dose (MRHD) (see Pharmacology: Toxicology: Preclinical safety data under Actions).
PNH in pregnancy is associated with adverse maternal outcomes, including worsening cytopenias, thrombotic events, infections, bleeding, miscarriages and increased maternal mortality, as well as adverse foetal outcomes, including foetal death and premature delivery.
The use of iptacopan in pregnant women or women planning to become pregnant may only be considered following a careful assessment of the risk and benefits, if necessary.
Breast-feeding: It is unknown whether iptacopan is excreted in human milk. There are no data on the effects of iptacopan on the breast-fed newborn/infant or on milk production.
A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from FABHALTA therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility: There are no data on the effect of iptacopan on human fertility. Available non-clinical data do not suggest an effect of iptacopan treatment on fertility (see Pharmacology: Toxicology: Preclinical safety data under Actions).