Ferinject Use In Pregnancy & Lactation

Pregnancy: There are limited clinical data from the use of Ferinject in pregnant women. A careful risk/benefit evaluation is required before use during pregnancy and Ferinject should not be used during pregnancy unless clearly necessary.
Iron deficiency occurring in the first trimester of pregnancy can in many cases be treated with oral iron. If the benefit of Ferinject treatment is judged to outweigh the potential risk to the fetus, it is recommended that treatment should be confined to the second and third trimester.
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.
Animal data suggest that iron released from Ferinject can cross the placental barrier and that its use during pregnancy may influence skeletal development in the fetus (see Pharmacology: Toxicology: Pre-clinical safety data under Actions).
Lactation: Clinical studies showed that transfer of iron from Ferinject to human milk was negligible (≤1%). Based on limited data on nursing women it is unlikely that Ferinject represents a risk to the nursing child.
Fertility: There are no data on the effect of Ferinject on human fertility. Fertility was unaffected following Ferinject treatment in animal studies (see Pharmacology: Toxicology: Pre-clinical safety data under Actions).