"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...
What is the most important information I should know about Feraheme?
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:
- dizziness or lightheadedness
- swelling of the tongue or throat
- wheezing or trouble breathing
See “What are the possible side effects of Feraheme?” for more information about side effects.
What is Feraheme?
Feraheme is a prescription medicine used to treat iron deficiency anemia in adults with chronic kidney disease (CKD).
It is not known if Feraheme is safe and effective in children less than 18 years of age.
Who should not receive Feraheme?
You should not receive Feraheme if you:
- are allergic to Feraheme or any of the ingredients in Feraheme. See the end of this leaflet for a complete list of ingredients in Feraheme.
- have had an allergic reaction to any iron medicine given into your vein by intravenous (IV) infusion.
Before receiving Feraheme, tell your healthcare provider about all of your medical conditions, including if you:
- have allergies to many different medicines.
- have low blood pressure (hypotension).
- are pregnant or plan to become pregnant. It is not known if Feraheme will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if Feraheme passes into your breast milk. You and your healthcare provider should decide if you will receive Feraheme or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Feraheme?
Feraheme will be given to you into your vein by intravenous (IV) infusion over at least 15 minutes by your healthcare provider. Your healthcare provider will watch you during and for at least 30 minutes after you receive Feraheme.
What are the possible side effects of Feraheme?
Feraheme can cause serious side effects, including:
- See “What is the most important information I should know about Feraheme?”
- 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, 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.
General information about the safe and effective use of Feraheme.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about Feraheme that is written for health professionals.
What are the ingredients in Feraheme?
Active ingredient: ferumoxytol
Inactive ingredient: mannitol
Last reviewed on RxList: 4/7/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Feraheme Information
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