FERAHEME delivers clinical efficacy in just 1 gram1,2

In the largest IV iron head-to-head, double-blind, non-inferiority trial of ~2000 patients, 1 gram of FERAHEME vs 1.5 grams of Injectafer® demonstrated the following2

Non-inferiority with respect to the composite endpoint of HSR and hypotension1,2

0.6 %

FERAHEME

VS
0.7 %

Injectafer®

Significantly lower rate of severe hypophosphatemia1-3

0.4 %

FERAHEME

VS
38.7 %

Injectafer®

Non-inferiority in Hgb increase1

1.38 g/dL

FERAHEME

VS
1.63 g/dL

Injectafer®

The largest IV iron head-to-head, double-blind trial of ~2000 patients focused on incidence of hypersensitivity2

Incidence of moderate to severe HSR (including anaphylaxis) or moderate to severe hypotension2

  • 0.6%

    6 patients
    FERAHEME (1.02 g) n=997
  • 0.7%

    7 patients
    Injectafer® (1.5 g) n=1000

-0.1%DIFFERENCE

(95% Cl, -0.91 to 0.70)

Non-inferiority
margin: 2.64%

P<0.0001

FERAHEME was non-inferior to Injectafer®2

FERAHEME (n=997) Patients (%) Injectafer® (n=1000) Patients (%)
Primary endpoint:
Composite of the following:
6 (0.6%) 7 (0.7%)
Moderate hypersensitivity reaction 3 (0.3%) 6 (0.6%)
Severe hypersensitivity reaction 1 (0.1%) 0 (0.0%)
Anaphylaxis 0 (0.0%) 0 (0.0%)
Moderate hypotension 2 (0.2%) 1 (0.1%)
Severe hypotension 0 (0.0%) 0 (0.0%)

Please see Important Safety Information, including Boxed Warning.

FERAHEME does not require pretreatment
or a test dose prior to use

Moderate HSR was defined as requiring minimal medical intervention or corrective treatment; severe HSR was characterized as requiring medical intervention or corrective treatment, with possible hospitalization. Anaphylaxis was defined as a sudden, severe, potentially fatal systemic allergic reaction as operationally defined using the Sampson criteria. Hypotension was defined as a >30% decrease from baseline in systolic blood pressure or a decrease of >20 mm Hg in systolic blood pressure with symptoms (dizziness/lightheadedness, fatigue, syncope, lack of consciousness, blurred vision).2

CI=confidence interval; Hgb=hemoglobin; HSR=hypersensitivity reaction; IDA=iron deficiency anemia.

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In the same study, FERAHEME had a significantly lower rate of severe hypophosphatemia vs Injectafer® (ferric carboxymaltose)1-3

Incidence of severe hypophosphatemia (defined by blood phosphorus of <0.6 mmol/L or <2.0 mg/dL at Week 2)1-3*

  • 0.4%

    4 patients
    FERAHEME (1.02 g) n=935
  • 38.7%

    361 patients
    Injectafer® (1.5 g) n=932

Patients were

91× MORE LIKELY

to experience severe
hypophosphatemia
with Injectafer®

(95% Cl, -41.5 to -35.2)

*An endpoint of severe hypophosphatemia was prespecified as serum phosphate level of <0.6 mmol/L or <2.0 mg/dL, which is defined as Grade 3 severity (severe or medically significant but not immediately life threatening; hospitalization; or prolongation of hospitalization indicated; disabling) by the Common Terminology Criteria for Adverse Events (CTCAE).3

FERAHEME demonstrated normal phosphate levels throughout the study period vs Injectafer® (ferric carboxymaltose)2,3

Serum phosphate levels2,3

40%DECREASE

in mean serum
phosphate by Week 2
among Injectafer®
treated patients vs
no change with
FERAHEME-treated
patients

P<0.0001.

After 5 weeks, severe hypophosphatemia

was not transient as it persisted in 29.1% of Injectafer®-treated
patients compared with 0% of those treated with FERAHEME4

Defined by blood phosphorus of <2.0 mg/dL at Week 5.4

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One gram of FERAHEME was non-inferior to 1.5 grams of Injectafer® (ferric carboxymaltose) with respect to Hgb rise at Week 51,2

Mean change in Hgb (g/dL) per full therapeutic dose1,2

  • 1.38g/dL

    (SD 1.35)
    FERAHEME (1.02 g) n=997
  • 1.63g/dL

    (SD 1.54)
    Injectafer® (1.5 g) n=1000

-0.24g/dLDIFFERENCE*

(95% CI, -0.35 to -0.13)

Non-inferiority
margin: -0.5 g/dL

*Adjusted for difference in baseline Hgb.

Just 1 gram of FERAHEME demonstrated normal levels of mean ferritin and TSAT at Week 5 vs 1.5 grams of Injectafer® (ferric carboxymaltose)2,5,6

FERAHEME
(1.02 g)
Injectafer®
(1.5 g)
Normal Range
Ferritin levels
Mean (SD)
227.5 ng/mL
(193.9 ng/mL)
397.8 ng/mL
(301.2 ng/mL)
40-300 ng/mL(Male)
20-200 ng/mL(Female)
TSAT levels
Mean (SD)
25.9%
(11.6%)
28.6%
(11.5%)
20%-50%

1 GRAM is the most common indicated dose of IV iron1,7,8

Select Important Safety Information: 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.

SD=standard deviation; TSAT=transferrin saturation.

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