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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.

Efficacy and safety in trials – adult IDA patients with CKD

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

In clinical trials of adult IDA patients with CKD who were nondialysis dependent (NDD):

  • Two 510-mg doses of FERAHEME raised mean Hgb by 1.2 g/dL (±1.3, standard deviation [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 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
  • 1 g is the most commonly recommended full therapeutic dose of IV iron2,3

Learn more about the trial design and the efficacy and safety of FERAHEME in trials.*

* The safety and efficacy of FERAHEME were also evaluated in patients on dialysis.1

Efficacy trials in adult IDA patients with CKD not dependent on dialysis1,4

Efficacy trials in CKD patients not dependent on dialysis Efficacy trials in CKD patients not dependent on dialysis
  • The efficacy and safety of FERAHEME were studied in 2 randomized, active-controlled, open-label pivotal trials vs oral iron (ferrous fumarate)1,†
    • FERAHEME was administered as two 510-mg IV single doses, with the second injection administered 3 to 8 days after the first injection1
    • Oral iron was administered as a total daily dose of 200 mg elemental iron for 21 days1,4
    • Primary end point: mean change in Hgb; baseline to day 351,4
  • Key inclusion criteria4
    • ≥18 years of age; CKD stages 1 to 5; Hgb ≤11.0 g/dL; TSAT ≤30%; serum ferritin ≤600 ng/mL

The safety and efficacy of FERAHEME were also evaluated in patients on dialysis.1


FERAHEME was proven to increase mean Hgb in adult IDA patients with CKD who were NDD in 2 pivotal trials vs oral iron1,5,‡,§

Trial 1: Mean change in Hgb levels from baseline with FERAHEME or oral iron1,5

Trial 1: Mean change in Hgb levels from baseline with FERAHEME or oral iron Trial 1: Mean change in Hgb levels from baseline with FERAHEME or oral iron
  • Mean Hgb increased by 1.2 g/dL in adult IDA patients with CKD who were NDD1,5,‡
  • Evaluated in 303 adult IDA patients with CKD stages 1 to 5 who were NDD5
  • Increase vs baseline at day 35 (P≤0.001)1
  • TSAT levels1:
    • FERAHEME 9.8% at baseline and 19.0% at day 35
    • Oral iron 10.4% at baseline and 10.7% at day 35

n values represent the ITT population. Actual n values used in analyses may vary depending on missing values, thus decreasing the n.1
§As demonstrated in 2 randomized, active-controlled, open-label pivotal trials in which 303 patients with CKD stages 1 to 5 who were NDD (Trial 1) and 304 patients with CKD stages 1 to 5 who were NDD (Trial 2) were randomized 3:1 to treatment with FERAHEME or oral iron. FERAHEME was administered as two 510-mg doses; most patients received their second FERAHEME injection 3 to 8 days after the first injection. Oral iron (ferrous fumarate) was administered as a total daily dose of 200-mg elemental iron for 21 days.1,5

Trial 2: Mean change in Hgb levels from baseline with FERAHEME or oral iron1,5

Trial 2: Mean change in Hgb levels from baseline with FERAHEME or oral iron Trial 2: Mean change in Hgb levels from baseline with FERAHEME or oral iron
  • Mean Hgb increased by 0.8 g/dL in adult IDA patients with CKD who were NDD1,5,||
  • Evaluated in 304 adult IDA patients with CKD stages 1 to 5 who were NDD5
  • Increase vs baseline at day 35 (P≤0.001)1
  • TSAT levels1:
    • FERAHEME 11.3% at baseline and 21.1% at day 35
    • Oral iron 10.1% at baseline and 11.4% at day 35

||n values represent the ITT population. Actual n values used in analyses may vary depending on missing values, thus decreasing the n.1


Adverse reactions reported in >1% of adult IDA patients with CKD treated with FERAHEME in 3 randomized, active‑controlled, open‑label studies

Adverse Reactions FERAHEME
2 x 510 mg
(N=605)
(%)
Oral iron
(N=280)
(%)
Nausea 3.1 7.5
Dizziness 2.6 1.8
Hypotension 2.5 0.4
Peripheral edema 2.0 3.2
Headache 1.8 2.1
Edema 1.5 1.4
Vomiting 1.5 5.0
Abdominal pain 1.3 1.4
Chest pain 1.3 0.7
Cough 1.3 1.4
Pruritus 1.2 0.4
Pyrexia 1.0 0.7
Back pain 1.0 0.0
Muscle spasms 1.0 1.4
Dyspnea 1.0 1.1
Rash 1.0 0.4
Diarrhea (4.0%), constipation (2.1%), and hypertension (1.0%) have also been reported in patients treated with FERAHEME.

Evaluated in 3 randomized clinical trials in which 605 patients were exposed to 2 injections of 510 mg of FERAHEME and a total of 280 patients were exposed to 200 mg/day of oral iron for 21 days; most patients received their second FERAHEME injection 3 to 8 days after the first injection.1


In a noninferiority study, FERAHEME demonstrated comparable efficacy to iron sucrose in IDA patients with CKD1,6

Primary efficacy endpoint: mean change in Hgb from baseline to Week 5#
Primary efficacy endpoint: mean change in Hgb from baseline to Week 5
0.1 g/dL
difference
95% CI for treatment difference
Non-inferiority margin: -0.5g/dL7
  • A randomized, open-label, active-controlled, multicenter clinical trial of 162 patients with IDA and CKD compared the efficacy and safety of FERAHEME versus iron sucrose6
  • FERAHEME was administered as two 510-mg injections for a total dose of 1.02 g6
  • Iron sucrose was administered as 1.0 g either by a slow injection or infusion (10 doses for dialysis patients; 5 doses for patients who were NDD)6
  • Mean change in Hgb from baseline to Week 5 was 0.71 ± 1.03 g/dL for FERAHEME-treated patients and 0.61 ± 0.97 g/dL for iron sucrose-treated patients1
#Adjusted for baseline Hgb and dialysis status.

AR: adverse reaction; CI: confidence interval; CKD: chronic kidney disease; Hgb: hemoglobin; IDA: iron deficiency anemia; ITT: intent to treat; IV: intravenous; TSAT: transferrin saturation.

 
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.

References: 1. Feraheme [prescribing information]. AMAG Pharmaceuticals, Inc; February 2018. 2. Ferrlecit [package insert]. Bridgewater, NJ: sanofi-aventis U.S. LLC; Mar 2015. 3. Venofer [package insert]. Shirley, NY: American Regent, Inc; November 2017. 4. Spinowitz BS, Kausz AT, Baptista J, et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008;19(8):1599-1605. 5. Data on file, AMAG Pharmaceuticals, Inc. 6. Macdougall IC, Strauss WE, McLaughlin J, et al. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency in anemia in patients with CKD. Clin J Am Soc Nephrol. 2014;9:705-712. doi:10.2215/CJN.05320513. 7. 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.