Velphoro Use In Pregnancy & Lactation

Pregnancy: There are no available clinical data from the use of Sucroferric oxyhydroxide (Velphoro) 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). Sucroferric Oxyhydroxide (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 Sucroferric Oxyhydroxide (Velphoro) in breast-feeding women. Since absorption of iron from Sucroferric Oxyhydroxide (Velphoro) is minimal (see Pharmacology: Pharmacokinetics under Actions), excretion of iron from Sucroferric Oxyhydroxide (Velphoro) in breast milk is unlikely. A decision on whether to continue breast-feeding or to continue therapy with Sucroferric Oxyhydroxide (Velphoro) should be made taking into account the benefit of breast-feeding to the child and the benefit of Sucroferric Oxyhydroxide (Velphoro) therapy to the mother.
Fertility: There are no data on the effect of Sucroferric Oxyhydroxide (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 (Velphoro) (see Pharmacology: Toxicology: Preclinical safety data under Actions).