Ferric carboxymaltose Pregnancy and Breastfeeding Warnings

Ferric carboxymaltose is also known as: Injectafer

Ferric carboxymaltose Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and increases in fetal skeletal abnormalities at maternally toxic IV iron doses. There are no controlled data in human pregnancy. Iron deficiency that occurs in the first trimester of pregnancy can generally be treated with oral iron therapy. If the benefits of ferric carboxymaltose outweigh the potential risks, its use should be restricted to the second and third trimester. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use only if the benefit outweighs the risk to the developing fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C

Ferric carboxymaltose Breastfeeding Warnings

Use is considered acceptable; caution is recommended. Excreted into human milk: Yes

The transfer of iron from ferric carboxymaltose was reported at 1% or lower. In a study of 25 lactating women with postpartum iron deficiency anemia, the mean breast milk iron levels were higher in lactating women receiving ferric carboxymaltose injection than in lactating women receiving oral ferrous sulfate. Out of the 229 women breastfeeding their infants in a study of postpartum mothers given intravenous ferric carboxymaltose, 24 infants had an adverse effect reported. The most frequent reactions were reported to include erythema, constipation, diarrhea, and nasopharyngitis.

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