Feraheme (ferumoxytol injection)

Feraheme is a prescription medicine used to treat iron deficiency anemia in adults who have:

• intolerance to oral iron or who have not responded well to treatment with oral iron or
• chronic kidney disease (CKD)

It is not known if Feraheme is safe and effective in children less than 18 years of age.

Feraheme may cause serious side effects including:

• Serious allergic reactions that can lead to death. Serious allergic reactions have happened in people after receiving the first dose of Feraheme or after receiving additional doses in people who did not previously have an allergic reaction. If you have a history of allergies to many different medicines, you may have an increased risk of serious allergic reactions to Feraheme. Tell your healthcare provider or get medical help right away if you get any of these signs or symptoms:
  • rash
  • itching
  • dizziness or lightheadedness
  • swelling of the tongue or throat
  • wheezing or trouble breathing
• Low blood pressure (hypotension) is a common side effect of Feraheme and can sometimes be serious. Your healthcare provider will check you for signs and symptoms of hypotension after each Feraheme infusion.
• Iron overload. Your healthcare provider will do blood tests to check your iron levels during treatment with Feraheme.

The most common side effects of Feraheme include: diarrhea, headache, nausea, dizziness, constipation, and swelling of your legs, feet, arms, or hands.

These are not all of the possible side effects of Feraheme. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Feraheme will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider. You will receive Feraheme in 2 doses 3 to 8 days apart.
• Your healthcare provider will watch you during and for at least 30 minutes after you receive Feraheme.

Drug-drug interaction studies with Feraheme were not conducted. Feraheme may reduce the absorption of concomitantly administered oral iron preparations.

Limited available data with ferumoxytol use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with untreated iron deficiency anemia (IDA) in pregnancy.

Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight.

There are no data on the presence of ferumoxytol in human milk, the effects on the breastfed child, or the effects on milk production. Ferumoxytol has been detected in the milk of lactating rats. However, due to species-specific differences in lactation physiology, the clinical relevance of these data are not clear. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Feraheme and any potential adverse effects on the breastfed child from Feraheme or from the underlying maternal condition.