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FERAHEME® (ferumoxytol injection) is now 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)

Close to continue to Feraheme.com to visit our IDA with CKD website.

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.
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.

AMAG Pharmaceuticals, Feraheme, and the logo designs presented in this material are registered trademarks of AMAG Pharmaceuticals, Inc.
©2018 AMAG Pharmaceuticals, Inc. All rights reserved. PP-FRH-US-00077

Important Information about Feraheme® (ferumoxytol) Injection

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.

KDOQI/KDIGO® guidelines for anemia* in adult patients with CKD

NKF KDOQI and KDIGO recommend monitoring iron levels in adult patients with CKD and intervening when either functional or absolute IDA is present1,2 *

KDOQI guidelines for patients not on dialysis and KDIGO guidelines for patients with kidney disease

*Different guidelines use slightly different Hgb ranges.

Based on patient symptoms and overall clinical goals including avoidance of transfusion, improvement in anemia-related symptoms, and after exclusion of active infection and other causes of ESA hyporesponsiveness.2

 CKD: chronic kidney disease; ESA: erythropoiesis-stimulating agent; Hgb: hemoglobin; IDA: iron deficiency anemia; IV: intravenous; KDIGO: Kidney Disease Improving Global Outcomes; KDOQI: Kidney Disease Outcomes Quality Initiative; NDD: nondialysis dependent; NKF: National Kidney Foundation; TSAT: transferrin saturation.

 
Important Information about Feraheme® (ferumoxytol injection)

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 3 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
Please click here to see full Prescribing Information, including Boxed Warning.
References: 1. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for anemia in chronic kidney disease. Am J Kidney Dis. 2006;47(5)(suppl 3):S1-S146. 2. KDIGO Clinical Practice Guideline for Anemia in Chronic Kidney Disease. Kidney Int Suppl. 2012;2(4):279-335.