What is the safety of Monoferric (ferric derisomaltose) during pregnancy?

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Last updated: February 27, 2025View editorial policy

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From the Guidelines

Monoferric (ferric derisomaltose) should be used with caution during pregnancy due to limited safety data, and its use should be reserved for cases where oral iron supplements are ineffective or not tolerated, and the benefits outweigh the potential risks. The safety of Monoferric during pregnancy is not well established, and healthcare providers typically prefer oral iron supplements as first-line treatment during pregnancy. While iron supplementation is crucial during pregnancy to prevent or treat anemia, the limited data on Monoferric's safety in pregnant women warrants caution. According to recent guidelines, intravenous iron formulations like Monoferric are generally reserved for cases where oral iron is ineffective, not tolerated, or when rapid correction of iron deficiency is required 1.

Some key points to consider when evaluating the safety of Monoferric during pregnancy include:

  • The potential benefits of treating iron deficiency anemia during pregnancy, which can lead to complications including preterm birth and low birth weight
  • The limited safety data available for Monoferric in pregnant women
  • The preference for oral iron supplements as first-line treatment during pregnancy
  • The need to weigh the potential benefits of Monoferric against its uncertain risks in pregnant women
  • The importance of discussing iron supplementation options with a healthcare provider to determine the most appropriate approach for each individual's situation.

It's worth noting that other intravenous iron formulations, such as ferric carboxymaltose, have been shown to be safe and efficacious in various conditions, including pregnancy, although the specific formulation and administration guidelines may vary 1. Ultimately, the decision to use Monoferric during pregnancy should be made on a case-by-case basis, taking into account the individual patient's needs and the potential risks and benefits of treatment.

From the Research

Safety of Monoferric (Ferric Derisomaltose) During Pregnancy

  • There are no direct studies on the safety of Monoferric (ferric derisomaltose) during pregnancy in the provided evidence.
  • However, a study 2 mentions a trial protocol for comparing intravenous iron isomaltoside (which is similar to ferric derisomaltose) with oral iron supplementation for treating iron deficiency in pregnancy.
  • The study 2 aims to assess the effects of intravenous iron supplementation on preventing iron deficiency anaemia and other maternal and infant outcomes, but it does not provide results on the safety of ferric derisomaltose during pregnancy.
  • Other studies 3, 4, 5, 6 discuss the safety and efficacy of iron supplementation during pregnancy, but they do not specifically mention Monoferric (ferric derisomaltose).
  • Therefore, there is limited evidence to assess the safety of Monoferric (ferric derisomaltose) during pregnancy, and more research is needed to determine its safety profile.

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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