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 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 in adult patients with 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.

Important Safety Information
Contraindications

Feraheme is contraindicated in patients with:

  • Known hypersensitivity to Feraheme or any of its components
  • History of allergic reaction to any intravenous iron product
Warnings and Precautions
  • Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous Feraheme 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.
  • Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each infusion.
  • In clinical studies predominantly in patients with CKD, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects. In other trials excluding patients with Stages 4 and 5 CKD, moderate to severe hypersensitivity reactions were reported in 2.6% (26/1,014) of patients treated with Feraheme.
  • In the post-marketing experience, fatal and serious anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.
  • Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme administration.
  • Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme.
  • As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.
Adverse Reactions
  • The most common adverse reactions (≥ 2%) following the administration of Feraheme are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.
  • In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.
  • The following additional serious adverse reactions have been reported from the post-marketing experience with Feraheme: tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme.

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. 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.