Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are no available clinical data from the use of sucroferric oxyhydroxide on exposed human pregnancies.

Reproductive and developmental toxicity studies in animals revealed no risk with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Sucroferric oxyhydroxide should only be used by pregnant women if clearly needed following careful assessment of benefit/risk.

Breast-feeding

There are no available clinical data from the use of Velphoro in breast-feeding women. Since absorption of iron from this medicinal product is minimal (see section 5.2), excretion of iron from sucroferric oxyhydroxide in breast milk is unlikely. A decision on whether to continue breast-feeding 
or to continue therapy with sucroferric oxyhydroxide should be made taking into account the benefit of breast-feeding to the child and the benefit of Velphoro therapy to the mother.

Fertility

There are no data on the effect of Velphoro on fertility in humans. In animal studies, there were no adverse effects on mating performance, fertility, and litter parameters following treatment with sucroferric oxyhydroxide (see section 5.3).