Store at 20° to 25°C (68° to 77°F). Excursions permitted to 15° – 30°C (59° – 86°F) [see USP controlled room temperature].
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Prior History of Allergies to Parenteral Iron Products
Question patients regarding any prior history of allergies to parenteral iron products [see Warnings and Precautions (5.1) ].
Advise patients to immediately report any symptoms of hypersensitivity that may develop during and following Feraheme administration, such as rash, itching, dizziness, light-headedness, swelling, and breathing problems [see Warnings and Precautions (5.1) ].
U.S Patents: 6,599,498 B1; 7,553,479 B2; 7,871,597 B2; 8,501,158 B2; 8,591,864 B2; 8,926,947 B2
Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451
|This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 02/2018|
Patient InformationFeraheme (FER-uh-heem)(ferumoxytol injection)
Feraheme may cause serious side effects including:
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 who have:
It is not known if Feraheme is safe and effective in children less than 18 years of age.
Who should not receive Feraheme?
Do not receive Feraheme if you:
Before receiving Feraheme, tell your healthcare provider about all of your medical conditions, including if you:
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 can cause serious side effects, including:
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.
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
Distributed by: AMAG Pharmaceuticals, Inc. Waltham, MA 02451 For more information, go to www.feraheme.com or call 1–877-411-2510.
Package Label — Principal Display Panel – 17 mL Vial, Feraheme Injection
Package Label — Principal Display Panel – Carton for Single Use Vial, Feraheme Injection
|FERAHEME ferumoxytol injection|
|Labeler — AMAG Pharmaceuticals, Inc. (017511155)|
|Baxter Pharmaceutical Solutions||604719430||MANUFACTURE (59338-775)|
|Patheon Manufacturing Services LLC||079415560||MANUFACTURE (59338-775)|
Revised: 09/2020 AMAG Pharmaceuticals, Inc.
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