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 Pharmacology: Toxicology: Preclinical safety data under Actions). Velphoro 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 Velphoro is minimal (see Pharmacology: Pharmacokinetics under Actions), excretion of iron from Velphoro in breast milk is unlikely. A decision on whether to continue breast-feeding or to continue therapy with Velphoro 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 Velphoro (see Pharmacology: Toxicology: Preclinical safety data under Actions).