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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.

NCCN Clinical Practice Guidelines® in Oncology (NCCN Guidelines®) for cancer- and chemotherapy-induced anemia* in adult patients1

Anemia awareness and identification are important because of the high prevalence of anemia and CKD in patients with cancer.

NCCN Guidelines® note that the etiology of anemia in patients with cancer is multifactorial and recommend evaluating underlying comorbidities, such as renal insufficiency, as potential causes of anemia

  • Hb level of 11 g/dL or below should prompt an evaluation of anemia. Guidelines consider Hgb of between 10 g/dL and the lower limit of normal to be mild2
  • Initiation of ESA and iron therapy:
    • Consider iron supplementation in patients with absolute iron deficiency (ferritin < 30 ng/mL AND TSAT < 20%)
    • For select patients with ferritin 30-500 ng/mL AND TSAT <50%, consider IV iron with ESA
    • For patients with ferritin 500-800 ng/mL AND TSAT <50%, no iron supplementation needed OR consider IV iron for select patients
    • In select patients, consider ESAs by FDA dosing/dosing adjustments

*Different guidelines use slightly different Hgb ranges.

The hemoglobin threshold for treatment and dosing with ESAs is different for chemotherapy-induced anemia and chronic kidney disease. For more details on the use of ESAs in patients with cancer and chronic kidney disease, see the NCCN Guidelines.

 CKD: chronic kidney disease; ESA: erythropoiesis-stimulating agent; Hb and Hgb: hemoglobin; NCCN: National Comprehensive Cancer Network®; FDA: Food and Drug Administration; 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. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cancer- and Chemotherapy-Induced Anemia V.1.2018. © National Comprehensive Cancer Network, Inc 2017. All rights reserved. Accessed September 27, 2017. To view the most recent and complete version of the guideline, go online to NCCN.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. National Institutes of Health, US Department of Health and Human Services. Common Terminology for Adverse Events (CTCAE). Version 4.03. Bethesda, MD: National Institutes of Health; 2010. NIH publication 09-5410.