You are now leaving Feraheme.com. AMAG Pharmaceuticals, Inc. is not responsible for the information contained in any of the linked third-party sites. Please review the site's Privacy Policy and Terms of Use, as AMAG's policies do not apply to third-party sites.

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.

IDA Clinical Trials

FERAHEME® delivers effective IV iron treatment for adult patients with iron deficiency anemia (IDA) with one gram of iron1

FERAHEME is indicated for the treatment of 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).

Choose one of the trials below:

IDA Trial 3
FERAHEME vs Injectafer®
(ferric carboxymaltose injection)

IDA Trial 2
FERAHEME vs Venofer®
(iron sucrose injection, USP)

IDA Trial 1 & Extension Trial
FERAHEME vs Placebo

IDA Trial 3
FERAHEME vs Injectafer®
(ferric carboxymaltose injection)

In one of the largest IV iron head-to-head trials to date, one gram of FERAHEME was non-inferior to 1.5 g of Injectafer® with respect to Hgb rise at Week 52

Mean change in Hgb (g/dL) per gram of iron administered1
IDA Clinical Trials Results: FERAHEME vs Injectafer®
0.26 g/dL
difference*
(95% CI = 0.17 to 0.36)
Non-inferiority margin: -0.5 g/dL2

Mean change in Hgb (g/dL) per full therapeutic dose1
IDA Clinical Trials Results: FERAHEME vs Injectafer®
-0.24 g/dL
difference*
(95% CI = -0.35 to -0.13)
Non-inferiority margin: -0.5 g/dL2
*Adjusted for difference in baseline Hgb.

Ferritin and TSAT levels reached a normal range at Week 5 with one gram of FERAHEME and one and a half grams of Injectafer®2
Week 5
Mean (SD)
FERAHEME
(1020 mg)
Injectafer®
(1500 mg)
Ferritin levels (ng/mL) 227.5 (193.9) 397.8 (301.2)
TSAT levels (%) 25.9 (11.6) 28.6 (11.5)

Composite endpoint hypersensitivity and hypotension

In this study, FERAHEME was non-inferior to Injectafer®

Incidence of moderate to severe HSR (including anaphylaxis) or moderate to severe hypotension1
IDA Clinical Trials Results: FERAHEME vs Injectafer®
-0.1%
difference*
(95% CI = -0.91% to 0.70%)
Non-inferiority margin: 2.64%2

In this study, the incidence of severe hypophosphatemia was less with FERAHEME than those with Injectafer®


Incidence of severe hypophosphatemia (defined by blood phosphorus of <0.6 mmol/L at Week 2)1,3
IDA Clinical Trials Results: FERAHEME vs Injectafer®

In IDA Trial 3, adverse reactions to FERAHEME reported in ≥1% of IDA patients

Adverse reactions to FERAHEME and Injectafer®1
Adverse Reactions FERAHEME
2 x 510 mg
(N=997)
%
Injectafer®
2 x 750 mg
(N=1000)
%
Headache 3.4 3.1
Nausea 1.8 3.4
Dizziness 1.5 1.6
Fatigue 1.5 1.2
Diarrhea 1 0.8
Back pain 1 0.4

Adverse Reactions In IDA Trial 3, adverse reactions leading to treatment discontinuation and occurring in ≥2 FERAHEME-treated patients included arthralgia (0.3%), dyspnea (0.3%), flushing (0.2%), chest discomfort (0.2%), chest pain (0.2%), nausea (0.2%), back pain (0.2%), dizziness (0.2%) and headache (0.2%).1


Study design in IDA Trial 31,3

IDA Trial 3 was a randomized (1:1), multicenter, double-blind, safety study of FERAHEME 2 x 510 mg (n=997) vs ferric carboxymaltose 2 x 750 mg (n=1000) for the treatment of IDA in adult patients with a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Both treatments were infused over at least 15 minutes. Most patients received their second infusion of FERAHEME or Injectafer® 7 (+1) days after the first infusion. The primary endpoint was to assess the incidence of moderate to severe hypersensitivity reactions (including anaphylaxis) or moderate to severe hypotension. Efficacy endpoints were the mean increase from baseline to Week 5 in Hgb per gram of iron administered, and mean change in Hgb from baseline to Week 5. An additional safety endpoint was a composite of the incidence of moderate to severe hypersensitivity reactions, serious cardiovascular events, and/or death. An additional endpoint was to determine the incidence of severe hypophosphatemia.

CI: confidence interval; Hgb: hemoglobin; HSR: hypersensitivity reaction; SD: standard deviation; TSAT: transferrin saturation.

References: 1. Feraheme [prescribing information]. AMAG Pharmaceuticals, Inc; February 2018. 2. Adkinson NF, Strauss WE, Macdougall IC, et al. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: a randomized trial. Am J Hematol. 2018;93(5):683-690. doi:10.1002/ajh.25060. 3. Data on file. AMAG Pharmaceuticals, Inc.

IDA Trial 2
FERAHEME vs Venofer®
(iron sucrose injection, USP)

In IDA Trial 2, FERAHEME demonstrated non-inferiority to Venofer®* in raising Hgb levels ≥2.0 g/dL at any time from baseline to Week 52

Proportion of patients with Hgb increase of ≥2.0 g/dL at any time from baseline to Week 51
IDA Clinical Trials Results: FERAHEME vs Venofer®
2.6%
difference*
(95% CI = -3.9% to 9.1%)
Non-inferiority margin : -15%2

*Venofer® is an iron replacement product indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).3

Mean change in Hgb from baseline to Week 52,4
Mean change in Hgb at any time from baseline to Week 5 Mean change in Hgb at any time from baseline to Week 5

Study design in IDA Trial 21

The safety and efficacy of FERAHEME in adult patients with iron deficiency anemia, regardless of etiology, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used, were assessed in a randomized, controlled clinical trial (IDA Trial 2) with FERAHEME administered as a rapid intravenous injection (prior method of administration that is no longer approved).

In IDA Trial 2, patients were randomized to treatment with FERAHEME or iron sucrose, FERAHEME (510 mg) and placebo were administered as 2 intravenous single-dose injections over 3-8 days, and iron sucrose (200 mg) was administered as 5 intravenous injections or infusions over a period of 14 days.

References: 1. Feraheme [prescribing information]. AMAG Pharmaceuticals, Inc; February 2018. 2. Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014;89(6):646-650. doi: 10.1002/ajh.23712. 3. Venofer® [package insert]. Shirley, NY: American Regent, Inc; November 2017. 4. Data on file. AMAG Pharmaceuticals, Inc.

IDA Trial 1 & Extension Trial
FERAHEME vs Placebo

In IDA Trial 1, 81% of FERAHEME-treated patients experienced an increase in ≥2 g/dL Hgb at any time from baseline to Week 51,2

IDA Clinical Trials Results: FERAHEME vs Placebo
75.6%
difference*
(95% CI = 71.2% to 80.0%)

In IDA Trial 1, fatigue-related symptoms and impacts were assessed with FACIT-Fatigue*

After 5 weeks, FERAHEME-treated patients reported greater improvement from baseline in fatigue score than did patients in the placebo arm1,2
IDA Clinical Trials Results: FERAHEME vs Placebo
4.9 points
difference*
(95% CI = 3.08 to 6.71)

*Score range from 0 to 52 with higher scores indicating less fatigue.


Study design in IDA Trial 11

The safety and efficacy of FERAHEME in adult patients with iron deficiency anemia, regardless of etiology, and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used, were assessed in a randomized, controlled clinical trial (IDA Trial 1) with FERAHEME administered as a rapid intravenous injection (prior method of administration that is no longer approved).

In IDA Trial 1, patients were randomized to treatment with FERAHEME or placebo.

In an extension trial, FERAHEME demonstrated consistent efficacy across multiple courses of therapy

Hgb at treatment period baseline and treatment period Week 5 by treatment course3

Hbg at treatment baseline and treatment period Week 5 by treatment course Hbg at treatment baseline and treatment period Week 5 by treatment course
  • Overall, 61% of ferumoxytol-treated patients did not require a second course of treatment over the 6-month study period3

95% confidence interval (CI) and p-value are from the paired t-test.

FACIT: Functional Assessment of Chronic Illness Therapy.

References: 1. Feraheme [prescribing information]. AMAG Pharmaceuticals, Inc; February 2018. 2. Vadhan-Raj S, Strauss W, Ford D, et al. The efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014;89(1):7-12. doi: 10.1002/ajh.23582. 3. Vadhan-Raj S, Ford DC, Dahl NV, et al. Safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy: Results of a phase III, open-label, 6-month extension study. Am J Hematol. 2016;91(2):E3-5. doi: 10.1002/ajh.24240.

 
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.
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 as early as 3 days and up 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.