Summary of Use during Lactation

Intravenous iron carboxymaltose increases breastmilk iron in mothers with iron deficiency anemia. Breastfed neonates of these mothers appear to have no serious adverse reactions. Ferric carboxymaltose appears to be acceptable to use in nursing mothers with no special precautions required. For additional information on iron use during breastfeeding, see the monograph on Iron Salts.

Drug Levels

Maternal Levels. A multi-center study of postpartum mothers with iron deficiency anemia (hemoglobin 105 g/L or less) compared iron carboxymaltose to oral ferrous sulfate. Mothers were given intravenous ferric carboxymaltose in a dose of 15 mg of iron/kg body weight to a maximum dose of 1000 mg over 15 minutes on day 1, with subsequent weekly doses until each woman's total iron requirement had been given. The first dose was given within 7 days postpartum and follow-up visits were at follow-up visits after 1, 2, 4, and 12 weeks postpartum. A subset of 11 mothers had their breastmilk iron measured before and after administration of iron carboxymaltose. Baseline breastmilk iron was 0.500 mg/kg. At 24 hours after the first dose, breastmilk iron increased to 1.447 mg/kg. One week after the first dose, breastmilk iron decreased to an average of 0.513 mg/kg. After the second dose at week 1, breastmilk iron increased to 0.615 mg/kg at 1 to 3 hours after the dose. Breastmilk iron was 0.991 mg/kg before the dose on week 2.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

In a study of postpartum mothers given intravenous ferric carboxymaltose, 229 were breastfeeding their infants. Among the breastfed infants, 24 infants (10.5%) had an adverse reaction reported. The most frequent reactions included erythema, constipation, diarrhea and nasopharyngitis. The overall rate of adverse reactions was similar to the rate (12%) in the control group whose mothers received oral ferrous sulfate.[1]

In a study of mothers with postpartum anemia, 16 women were given 1000 mg ferric carboxymaltose intravenously as a single dose, either alone (n = 8) or in combination with a red blood cell transfusion (n = 8). At the time of the iron infusion, 13 of the women were exclusively or fully breastfeeding and 2 were partially breastfed. No adverse effects in breastfed infants were reported.[2]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Ferric Derisomaltose, Iron Sucrose

References

1.

Breymann C, Gliga F, Bejenariu C, Strizhova N. Comparative efficacy and safety of intravenous ferric carboxymaltose in the treatment of postpartum iron deficiency anemia. Int J Gynaecol Obstet 2008;101:67-73. [PubMed: 18234203]

2.

Caljé E, Oyston C, Wang Z, et al. The fatigue after infusion or transfusion pilot trial and feasibility study: A three-armed randomized pilot trial of intravenous iron and blood transfusion for the treatment of postpartum anemia. Transfusion 2023. [PubMed: 38149691]

Substance Name

Ferric Carboxymaltose

CAS Registry Number

9007-72-1

Drug Class

Breast Feeding

Lactation

Milk, Human

Ferric Compounds

Hematinics

Iron Compounds