The safety profile of FERAHEME was evaluated in ~2000 iron deficiency anemia (IDA) patients1

Adverse reactions to FERAHEME reported in ≥1% of IDA patients in IDA Trial 31

Adverse Reactions FERAHEME (n=997) Injectafer® (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% 0.8%
Back pain 1.0% 0.4%
  • 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

IDA Trials 1 and 2 and non-inferiority CKD Trial*

  • Adverse reactions related to FERAHEME and reported by ≥1% of FERAHEME-treated patients in IDA Trials 1 and 2 were similar to those seen in IDA Trial 31
  • In IDA Trials 1 and 2, adverse reactions leading to treatment discontinuation and occurring in ≥2 FERAHEME-treated patients included hypersensitivity (0.6%), hypotension (0.3%), and rash (0.2%)1
  • In IDA Trial 2, TEAEs (FERAHEME, 41.4% vs Venofer®, 44.2%) and drug-related TEAEs (FERAHEME, 14.3% vs Venofer®, 16.1%) were reported at similar rates between both treatment groups2
  • In a head-to-head randomized, open-label, multicenter clinical CKD trial of FERAHEME (1.02 g) vs Venofer® (1.0 g), the rates of the following were similar between both treatment arms1,3:
    • AEs (FERAHEME, 48% vs Venofer®, 65%)
    • Related AEs (FERAHEME, 10% vs Venofer®, 16%)
    • SAEs (FERAHEME, 9% vs Venofer®, 7%)
    • Related SAEs (FERAHEME, 1% vs Venofer®, 1%)
    • AEs leading to drug discontinuation (FERAHEME, 1% vs Venofer®, 5%)

*FERAHEME was administered as a rapid intravenous injection (prior method of administration that is no longer approved).

Long-term safety profile with repeat dosing*

  • In a randomized, open-label study of CKD patients undergoing HD over a 1-year period, repeat dosing of FERAHEME (n=196) had a safety profile comparable to Venofer® (n=97)4
    • TEAEs (FERAHEME, 80.6% vs Venofer®, 83.5%) and drug-related TEAEs (FERAHEME, 4.6% vs Venofer®, 4.1%) were reported at similar rates between both treatment groups
  • In a 6-month, open-label extension study following IDA Trial 1, adverse reactions following repeat FERAHEME dosing were generally similar in type and frequency to those observed after the first 2 administrations1,5

FERAHEME vs oral iron in patients with CKD*

Adverse reactions within IDA Trial 1, 2, and 3 reported in ≥1% of patients with CKD treated with FERAHEME vs oral iron1

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
  • In these clinical trials in patients with IDA and CKD, adverse reactions leading to treatment discontinuation and occurring in ≥2 FERAHEME-treated patients included hypotension (0.4%), chest pain (0.3%), and dizziness (0.3%)1

*FERAHEME was administered as a rapid intravenous injection (prior method of administration that is no longer approved).

AE=adverse event; CKD=chronic kidney disease; HD=hemodialysis; SAE=serious adverse event; TEAE=treatment-emergent adverse event.

Select Important Safety Information:

  • Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving FERAHEME
  • Hypotension: FERAHEME may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following each FERAHEME administration
  • Please see full Prescribing Information, including Boxed Warning

FERAHEME vs Injectafer®. See head-to-head clinical data.

SEE RESULTS

References: 1. Feraheme [prescribing information]. AMAG Pharmaceuticals, Inc; September 2020. 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. 3. Macdougall IC, Strauss WE, McLaughlin J, Li Z, Dellanna F, Hertel J. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin Am J Soc Nephrol. 2014;9(4):705-712. 4. Macdougall IC, Strauss WE, Dahl NV, Bernard K, Li Z. Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial. Clin Nephrol. 2019;91(4):237-245. 5. 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-E5 and supplementary online content. doi:10.1002/ajh.24240.