What is the recommended protocol for intravenous (IV) iron therapy in pregnant women with severe iron deficiency anemia?

From the Guidelines

Intravenous iron therapy is recommended for pregnant women with severe iron deficiency anemia, as it is a safe and effective treatment option, according to the expert consensus guidelines published in 2024 1. The use of IV iron in pregnant women is supported by the fact that it can rapidly replenish iron stores, bypassing the limited absorption of oral iron through the gastrointestinal tract, and effectively raising hemoglobin levels within 2-3 weeks. Some key points to consider when administering IV iron therapy to pregnant women include:

• The preferred IV iron formulations include iron sucrose and ferric carboxymaltose, which can be given in different dosing regimens, such as 200 mg doses 1-3 times weekly or larger single doses of 500-1000 mg, respectively.
• Administration should occur during the second or third trimester when possible, as first-trimester use lacks robust safety data.
• Before infusion, patients should be assessed for allergic risk, and vital signs should be monitored during and after administration.
• The infusion rate should follow manufacturer guidelines, typically starting slowly and increasing gradually. The benefits of IV iron therapy in pregnant women with severe iron deficiency anemia include preventing maternal and fetal complications associated with severe anemia during pregnancy, such as preterm birth, low birth weight, and increased risk of maternal mortality, as highlighted in the expert consensus guidelines 1. Key considerations for the management of IV iron therapy in pregnant women include:
• Calculating the total iron deficit to determine the required dose and duration of treatment
• Monitoring for potential infusion reactions and treatment-emergent hypophosphatemia
• Ensuring adequate patient education and follow-up care to minimize risks and optimize outcomes.

From the FDA Drug Label

2 DOSAGE AND ADMINISTRATION

1. 1 Recommended Dosage Recommended Dosage for Treatment of Iron Deficiency Anemia For patients weighing 50 kg or more, the recommended dosage is: Injectafer 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course In adult patients, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course. For patients weighing less than 50 kg, the recommended dosage is Injectafer 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course

The recommended protocol for intravenous (IV) iron therapy in pregnant women with severe iron deficiency anemia is to administer Injectafer according to the patient's weight:

• For patients weighing 50 kg or more: 750 mg intravenously in two doses separated by at least 7 days for a total cumulative dose of 1,500 mg of iron per course
• For patients weighing less than 50 kg: 15 mg/kg body weight intravenously in two doses separated by at least 7 days per course
• Alternatively, in adult patients, Injectafer 15 mg/kg body weight up to a maximum of 1,000 mg intravenously may be administered as a single-dose per course 2

From the Research

Recommended Protocol for IV Iron Therapy in Pregnant Women

The recommended protocol for intravenous (IV) iron therapy in pregnant women with severe iron deficiency anemia is as follows:

• IV iron sucrose and oral iron therapy are the main therapies for iron deficiency anemia (IDA) during pregnancy 3.
• IV iron sucrose is associated with fewer adverse events and is more effective than regular oral iron therapy for pregnant women who cannot tolerate the side effects of oral treatment or require rapid replacement of iron stores 3, 4.
• National guidelines provide varying guidance on diagnosis and treatment of IDA in pregnancy, but serum ferritin is a helpful adjunct for diagnosis 5.
• Emerging studies on modern generations of IV iron demonstrate shorter infusion times and improved safety profiles 5.
• IV ferric carboxymaltose (FCM) is effective and safer than IV iron sucrose in terms of hematological parameters, with fewer adverse events 6.

Treatment Outcomes

The treatment outcomes for IV iron therapy in pregnant women with severe iron deficiency anemia include:

• Significant increases in hemoglobin and ferritin levels 3, 4, 6.
• Fewer adverse events compared to oral iron therapy 3, 4, 6.
• Improved maternal and neonatal outcomes, although more research is needed to fully understand the effects of IV iron on pregnancy and neonatal outcomes 5, 6, 7.
• Reduced rates of maternal anemia at delivery 7.

Administration and Dosage

The administration and dosage of IV iron therapy in pregnant women with severe iron deficiency anemia include:

• IV iron sucrose can be given in divided doses of 200 mg each on alternate days by slow intravenous infusion 4.
• A single 1,000-mg dose of IV low-molecular weight iron dextran can be given over one hour 7.
• The dosage and administration of IV iron therapy may vary depending on the specific product and patient needs, and should be determined by a healthcare provider 5, 6.