Important Information about Feraheme® (ferumoxytol) Injection

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 recommends evaluating underlying comorbidities, such as renal insufficiency, as potential causes of anemia

  • Anemia is considered at Hgb ≤ 11 g/dL or ≥ 2 g/dL below baseline
  • Initiation of ESA and iron therapy:
    • Consider for iron repletion in patients with absolute iron deficiency (ferritin < 30 ng/mL and TSAT < 20%)
    • Can also be considered in combination with erythropoietic drugs for patients with functional iron deficiency (ferritin 30 ng/mL to 800 ng/mL and TSAT 20% to 50%)
    • Consider ESAs by FDA indications/dosing/dosing adjustments for chronic kidney disease, under REMS guidelines, with informed consent

*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; Hgb: hemoglobin; NCCN: National Comprehensive Cancer Network®; REMS: Risk Evaluation & Mitigation Strategies; TSAT: transferrin saturation

 
Important Information about Feraheme® (ferumoxytol) Injection

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

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.

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.
  • Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.
  • 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.
Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Cancer- and Chemotherapy-Induced Anemia V.2.2015. © National Comprehensive Cancer Network, Inc 2014. All rights reserved. Accessed March 20, 2015. To view the most recent and complete version of the guideline, go online to www.nccn.org. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, NCCN GUIDELINES®, and all other NCCN Content are trademarks owned by the National Comprehensive Cancer Network, Inc.