Ferric carboxymaltose Pregnancy and Breastfeeding Warnings

Ferric carboxymaltose is also known as: Injectafer

Ferric carboxymaltose Pregnancy Warnings

The administration of ferric carboxymaltose in animals during the period of organogenesis resulted in fetal malformations and increased implantation loss at maternally toxic doses of approximately 12% to 23% of the human weekly dose of 750 mg. In addition, malformation were seen starting at daily doses of 9 mg/kg (23% of the human weekly dose of 750 mg), spontaneous abortions occurred starting at daily doses of 4.5 mg/kg (12 % of the human weekly dose), and adverse embryofetal effects were seen during maternal toxicity. The incidence of major malformations in human pregnancy has not been established. There are no controlled data in human pregnancy. 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.

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

Ferric carboxymaltose Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Yes Excreted into animal milk: Data not available The effects in the nursing infant are unknown.

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.

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