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.

Clinical Information

Administration flexibility with 2 infusions 3 to 8 days apart. Duration of delivery for diluted IV infusion is at least 15 minutes.

A flexible infusion schedule1

A full 1-g dose of Feraheme can be delivered in 2 IV infusions.1 Duration of delivery for diluted IV infusion is at least 15 minutes2

Important Safety Information1
  • Only administer Feraheme when personnel and therapies are immediately available for 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 trials, Feraheme raised mean Hgb 1 g/dL with only 1 g of IV iron.  Two 510-mg doses of Feraheme raised mean Hgb in adult patients with CKD who were NDD by 1.2 g/dL (± 1.3, SD; P ≤ 0.001) in Clinical Trial 1 and by 0.8 g/dL (± 1.2, SD; P ≤ 0.001) in Clinical Trial 2 vs baseline at day 35.

Feraheme raised mean Hgb 1 g/dL with 1 g of IV iron in 35 days1

In clinical trials of adult patients with CKD who were NDD1

  • Two 510-mg doses of Feraheme raised mean Hgb by 1.2 g/dL (± 1.3, standard deviation [SD]; P >e; 0.001) in clinical trial 1 and by 0.8 g/dL (± 1.2, SD; P >e; 0.001) in clinical trial 2 vs baseline at day 351
  • Following completion of the controlled phase of the trials, 69 patients received 2 additional 510-mg IV injections of Feraheme for a total cumulative dose of 2.04 g. On day 35 following the additional injections, 70% of these patients experienced an increase in Hgb and iron parameters (TSAT and ferritin)1
More 1,500,000 US patient exposures have been recorded since Feraheme became commercially  available in July 2009

Proven experience

  • Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure
  • The following serious adverse reactions have been reported from the postmarketing experience with Feraheme: fatal, life-threatening, and serious anaphylactic-type reactions; cardiac/cardiorespiratory arrest; clinically significant hypotension; syncope; unresponsiveness; loss of consciousness; 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

*As of August 2016.

CKD: chronic kidney disease; Hgb: hemoglobin; IV: intravenous; NDD: nondialysis dependent

 
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.

Reference: 1. Feraheme [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc; Mar 2015. 2. Data on file, AMAG Pharmaceuticals, Inc.