Ferinject Use In Pregnancy & Lactation

Pregnancy: There are limited data from the use of Ferric carboxymaltose (Ferinject) in pregnant women (see Pharmacology: Pharmacodynamics under Actions). A careful benefit/risk evaluation is required before use during pregnancy and Ferric carboxymaltose (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. Treatment with Ferric carboxymaltose (Ferinject) should be confined to the 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.
Animal data suggest that iron released from Ferric carboxymaltose (Ferinject) can cross the placental barrier and that its use during pregnancy may influence skeletal development in the fetus (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Breast-feeding: Clinical studies showed that transfer of iron from Ferric carboxymaltose (Ferinject) to human milk was negligible (≤1%). Based on limited data on breast-feeding women it is unlikely that Ferric carboxymaltose (Ferinject) represents a risk to the breast-fed child.
Fertility: There are no data on the effect of Ferric carboxymaltose (Ferinject) on human fertility. Fertility was unaffected following Ferric carboxymaltose (Ferinject) treatment in animal studies (see Pharmacology: Toxicology: Preclinical safety data under Actions).