Venofer Use In Pregnancy & Lactation

Pregnancy: There is no or only a limited amount of data (less than 300 pregnancy outcomes) from the use of iron sucrose in pregnant women in the first trimester. A moderate amount of data (between 300-1,000 pregnancy outcomes) from the use of Venofer in pregnant women in the second and third trimester showed no safety concerns for the mother or newborn.
Venofer should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus, particularly during the first trimester (see Precautions).
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breastfeeding: There is limited information on the excretion of iron in human milk following administration of intravenous iron sucrose. In one clinical study, 10 healthy breast-feeding mothers with iron deficiency received 100 mg iron in the form of iron sucrose. Four days after treatment, the iron content of the breast milk had not increased and there was no difference from the control group (n=5). It cannot be excluded that newborns/infants may be exposed to iron derived from Venofer via the mother's milk, therefore the risk/benefit should be assessed.
Preclinical data do not indicate direct or indirect harmful effects to the nursing child. In lactating rats treated with ⁵⁹Fe-labelled iron sucrose, low secretion of iron into the milk and transfer of iron into the offspring was observed. Non metabolised iron sucrose is unlikely to pass into the mother's milk.
Fertility: No effects of iron sucrose treatment were observed on fertility, mating performance and early embryonic development in rats.