Monofer Use In Pregnancy & Lactation

Pregnancy: There is only limited data from the use of Monofer in pregnant women from one study with 100 exposed pregnant women. A careful risk/benefit evaluation is therefore required before use during pregnancy.
Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron. Treatment with Monofer should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Foetal bradycardia may occur following administration of parenteral irons. It is usually transient and a consequence of a hypersensitivity reaction in the mother. The unborn baby should be carefully monitored during intravenous administration of parenteral irons to pregnant women.
Breast-feeding: A clinical study showed that transfer of iron from Monofer to human milk was very low. At therapeutic doses of Monofer no effects on the breastfeed newborns/infants are anticipated.
Fertility: There are no data on the effect of Monofer on human fertility. Fertility was unaffected following Monofer treatment in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).