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Feraheme® (ferumoxytol injection) Important Safety Information

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

  • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.

Understanding Iron Deficiency Anemia

What is iron deficiency anemia?

Iron deficiency anemia (IDA) is a common, treatable condition that occurs when iron stores are depleted due to an imbalance between iron uptake and iron utilization.

Explore some of the medical conditions that put your patients at risk for iron deficiency.

IDA affects an estimated 5 million adults in the United States.1


Causes & symptoms

Risk Factors for IDA

Women are generally at greater risk for IDA than men.2 However, men may also be affected. These are common medical conditions in adults at risk for IDA:

  • Cancer: IDA is prevalent in oncology patients3
  • GI conditions: Acute and chronic conditions, including gastric bypass, IBD, GI bleeding-related conditions, gastritis, ulcer-related conditions, and others4,5
  • Abnormal uterine bleeding: In women, there are several causes of heavy uterine bleeding that result in low iron levels6
  • Chronic kidney disease (CKD): IDA occurs in CKD, which affects about 30 million adults in the United States7

Common IDA Symptom of Fatigue

One of the most common symptoms that patients with IDA may present with is fatigue.5


Considerations when diagnosing IDA

IDA can be assessed through laboratory measurements.

Common laboratory markers are Hgb, serum ferritin, and TSAT.8,9

Normal Lab Values for Iron Status Assessment8-10

Lab Markers Normal Values
Hgb (hemoglobin)* 13.5-17.5 g/dL (male) 12.0-15.5 g/dL (female)
Ferritin 40-300 mcg/L (male) 20-200 mcg/L (female)
TSAT (transferrin saturation) 20%-50%

*Normal Hgb values may vary based on patient characteristics/comorbidities and by laboratory.

GI: gastrointestinal; IBD: irritable bowel disease.

 
Feraheme® (ferumoxytol injection) Important Safety Information

WARNING: RISK FOR SERIOUS HYPERSENSITIVITY/ANAPHYLAXIS REACTIONS

Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.

  • Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
  • Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.
  • Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.
Indication and Dosing

Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:

  • who have intolerance to oral iron or have had unsatisfactory response to oral iron or
  • who have chronic kidney disease (CKD)

The recommended dose of FERAHEME is an initial 510 mg dose followed by a second 510 mg dose as early as 3 days and up to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.

Contraindications

Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components or a history of allergic reaction to any intravenous iron product.

Warnings and Precautions

Hypersensitivity: In addition to the fatal and serious adverse reactions in the Boxed Warning, other adverse reactions associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). Allergic reactions have occurred following the first dose or subsequent doses in patients in whom a previous dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.

Hypotension: Feraheme may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following each Feraheme administration.

Iron Overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy. Do not administer Feraheme to patients with iron overload.

Magnetic Resonance (MR) Imaging Test Interference: Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration.

Adverse Reactions

The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.

You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.

References: 1. Miller JL. Iron deficiency anemia: a common and curable disease. Cold Spring Harb Perspect Med. 2013;3(7):1-13. 2. Iron deficiency anemia: symptoms & causes. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/iron-deficiency-anemia/symptoms-causes/syc-20355034. Updated November 11, 2016. Accessed April 23, 2018. 3. Naoum FA. Iron deficiency anemia in cancer patients. Rev Bras Hematol Hemoter. 2016;38(4):325-330. 4. Goldberg ND. Iron deficiency anemia in patients with inflammatory bowel disease. Clin Exp Gastroenterol. 2013;6:61-70. 5. Iron deficiency anemia. American Society of Hematology website. http://www.hematology.org/Patients/Anemia/Iron-Deficiency.aspx. Accessed April 23, 2018. 6. Vadhan-Raj S, Strauss W, Ford D, et al. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014;89(1):7-12. 7. National Center for Chronic Disease Prevention and Health Promotion, Division of Diabetes Translation. National chronic kidney disease fact sheet, 2017. Published June 7, 2017. Accessed April 23, 2018. 8. Iron deficiency anemia: diagnosis & treatment. Mayo Clinic website. https://www.mayoclinic.org/diseases-conditions/iron-deficiency-anemia/diagnosis-treatment/drc-20355040. Updated November 11, 2016. Accessed April 23, 2018. 9. Wish JB. Assessing iron status: beyond serum ferritin and transferrin saturation. Clin J Am Soc Nephrol. 2006;1(Suppl 1):S4-S8. 10. Camaschella C. Iron-deficiency anemia. N Engl J Med. 2015;372(19):1832-1843. doi: 10.1056/NEJMra1401038.