The Basics

What is Iron Isomaltoside 1000?

Indicated for the treatment of iron deficiency anemia in adult patients who have intolerance or unresponsiveness to oral iron therapy.

Brand names for Iron Isomaltoside 1000

Monoferric

How Iron Isomaltoside 1000 is classified

Ferric Compounds, Hematinics

Iron Isomaltoside 1000 During Pregnancy

Iron Isomaltoside 1000 pregnancy category

Category N/ANote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Iron Isomaltoside 1000 while pregnant

N/A

Taking Iron Isomaltoside 1000 While Breastfeeding

What are recommendations for lactation if you're taking Iron Isomaltoside 1000?

Iron isomaltoside 1000 is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Limited data indicate that breastmilk iron is increased 3 days after an intravenous infusion of iron isomaltoside, but within the normal range. By 7 days after the dose, breastmilk iron levels were similar to that of mothers taking oral iron. Iron isomaltoside 1000 appears to be acceptable to use in nursing mothers with no special precautions required. Pasteurization of milk by the Holder method reduces the concentration of iron in milk by about 6.5%.[1]

Maternal / infant drug levels

Iron isomaltoside 1000 is not approved for marketing in the United States by the U.S. Food and Drug Administration, but is available in other countries. Limited data indicate that breastmilk iron is increased 3 days after an intravenous infusion of iron isomaltoside, but within the normal range. By 7 days after the dose, breastmilk iron levels were similar to that of mothers taking oral iron. Iron isomaltoside 1000 appears to be acceptable to use in nursing mothers with no special precautions required. Pasteurization of milk by the Holder method reduces the concentration of iron in milk by about 6.5%.[1]

Possible effects of Iron Isomaltoside 1000 on milk supply

In a randomized, nonblinded study, randomly assigned to receive either a single intravenous dose of 1200 mg iron isomaltoside (n = 97) or oral iron 40 to 50 mg oral iron daily or 100 mg oral iron one or two times daily (n = 99). There was no significant difference between groups in the median time to lactogenesis, nor in the time of discontinuation of breastfeeding among those who weaned their infants.[3]

Possible alternatives to Iron Isomaltoside 1000

Ferric Carboxymaltose, Iron Sucrose.

List of References

Lactation sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/1. Mohd-Taufek N, Cartwright D, Davies M et al. The effect of pasteurization on trace elements in donor breast milk. J Perinatol. 2016;36:897-900. PMID: 27253894
2. Holm C, Thomsen LL, Norgaard A et al. Iron concentration in breast milk normalised within one week of a single high-dose infusion of iron in randomised controlled trial. Acta Paediatr. 2017;106:256-60. PMID: 27883237
3. Holm C, Thomsen LL, Norgaard A et al. Single-dose intravenous iron infusion or oral iron for treatment of fatigue after postpartum haemorrhage: A randomized controlled trial. Vox Sang. 2017;112:219-28. PMID: 28198084

Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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