Specialty Specific

In a post hoc subgroup analysis of IDA Trials 1 and 2,
FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and cancer^1*

The most common cancers were gastrointestinal (43%), breast (14%), cervix (10%), and lung (9%).¹

For patients with cancer and IDA (n=75), FERAHEME demonstrated significant increase in Hgb from baseline to Week 5¹

1.8^g/dLINCREASE

at Week 5

Paired t tests.
Error bars represent 95% confidence intervals.

*Included patients whose cancer was identified as the primary cause of their IDA as well as other patients with cancer whose IDA was attributed to another condition by the investigators.

Hgb=hemoglobin.

See head-to-head clinical trial data vs Injectafer^® (ferric carboxymaltose)

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying gastrointestinal (GI) disorders^3-5*

In IDA Trials 1 and 2, approximately 31% of patients treated with FERAHEME had IDA caused by underlying GI disorders^3,4

Proportion of patients with IDA caused by underlying GI disorders with Hgb increase of ≥2 g/dL at any time from baseline to Week 5^3-5

82.1^%†
142 patients

FERAHEME (n=173)
1.7^%
1 patient

Placebo (n=58)

80.4^%DIFFERENCE

(95% Cl, 73.7, 86.98)

80.4^%
111 patients

FERAHEME (n=138)
80.3^%
53 patients

Venofer^® (n=66)

0.13^%DIFFERENCE

(95% Cl, -11.52 to 11.79)

Non-inferiority
margin: -15%

*Prespecified subgroup.
^†P<0.0001.

Hgb=hemoglobin.

See head-to-head clinical trial data vs Injectafer^® (ferric carboxymaltose)

In patients with previous intolerance to oral iron, clinically active inflammatory bowel disease (IBD), or Hgb levels below 10 g/dL, IV iron should be considered as a first-line treatment. According to the international consensus statement, oral iron is effective in patients with IBD and patients with mild anemia, whose disease is clinically inactive, and who have not been previously intolerant to oral iron.⁶

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying abnormal uterine bleeding (AUB)^3-5*

In IDA Trials 1 and 2, approximately 44% of patients treated with FERAHEME had IDA caused by underlying AUB^3,4

Proportion of patients with IDA caused by underlying AUB with Hgb increase of ≥2 g/dL at any time from baseline to Week 5^3-5

87.3^%†
227 patients

FERAHEME (n=260)
3.6^%
3 patients

Placebo (n=84)

83.7^%DIFFERENCE

(95% Cl, 78.07, 89.40)

94.5^%
172 patients

FERAHEME (n=182)
92.4^%
85 patients

Venofer^® (n=92)

2.11^%DIFFERENCE

(95% Cl, -4.24 to 8.46)

Non-inferiority
margin: -15%

*Prespecified subgroup.
^†P<0.0001.

Hgb=hemoglobin.

See head-to-head clinical trial data vs Injectafer^® (ferric carboxymaltose)

For patients with gynecologic diagnoses associated with heavy uterine bleeding, those with anemia were 34x more likely to have a blood transfusion and 8x more likely to be admitted to the emergency department vs those without anemia.⁷

FERAHEME demonstrated non-inferior efficacy to Venofer^® (iron sucrose) in iron deficiency anemia (IDA) patients with chronic kidney disease (CKD)⁸

The CKD Trial included both dialysis-dependent and non-dialysis-dependent patients.

Mean change in Hgb from baseline to Week 5 in IDA patients with CKD⁸

Error bars represent 95% CI.

Comparable increases in Hgb were achieved in both treatment groups from baseline to Week 5⁸

Primary efficacy endpoint: mean change in Hgb from baseline to Week 5 in IDA patients with CKD^2,8

0.71^g/dL
±1.03

FERAHEME (n=80)
0.61^g/dL
±0.97

Venofer^® (n=82)

0.1^g/dLDIFFERENCE

(95% Cl, -0.21 to 0.41)

Non-inferiority
margin: -0.5 g/dL

96% of FERAHEME-treated patients

completed both doses of the study medication in the CKD Trial⁸

Hgb=hemoglobin.

Changes in Hgb, ferritin, and TSAT levels from baseline to Day 35 in intent-to-treat population²

Endpoint	CKD TRIAL 1 Non-Dialysis		CKD TRIAL 2 Non-Dialysis		CKD TRIAL 3 Dialysis
	FERAHEME n=226	Oral Iron n=77	FERAHEME n=228	Oral Iron n=114	FERAHEME n=114	Oral Iron n=116
Change in Hgb Mean (SD)	1.2g/dL* (1.3 g/dL)	0.5g/dL (1.0 g/dL)	0.8g/dL* (1.2 g/dL)	0.2g/dL (1.0 g/dL)	1.0g/dL* (1.1 g/dL)	0.5g/dL (1.1 g/dL)
Change in ferritin levels Mean (SD)	300.7ng/mL (214.9 ng/mL)	0.3ng/mL (82.0 ng/mL)	381.7ng/mL (278.6 ng/mL)	6.9ng/mL (60.1 ng/mL)	233.9ng/mL (207.0 ng/mL)	-59.2ng/mL (106.2 ng/mL)
Change in TSAT levels Mean (SD)	9.2% (9.4%)	0.3% (4.7%)	9.8% (9.2%)	1.3% (6.4%)	6.4% (12.6%)	0.6% (8.3%)

Endpoint	CKD TRIAL 1 Non-Dialysis
	FERAHEME n=226	Oral Iron n=77
Change in Hgb Mean (SD)	1.2 g/dL* (1.3 g/dL)	0.5 g/dL (1.0 g/dL)
Change in ferritin levels Mean (SD)	300.7 ng/mL (214.9 ng/mL)	0.3 ng/mL (82.0 ng/mL)
Change in TSAT levels Mean (SD)	9.2% (9.4%)	0.3% (4.7%)

Endpoint	CKD TRIAL 2 Non-Dialysis
	FERAHEME n=228	Oral Iron n=114
Change in Hgb Mean (SD)	0.8 g/dL* (1.2 g/dL)	0.2 g/dL (1.0 g/dL)
Change in ferritin levels Mean (SD)	381.7 ng/mL (278.6 ng/mL)	6.9 ng/mL (60.1 ng/mL)
Change in TSAT levels Mean (SD)	9.8% (9.2%)	1.3% (6.4%)

Endpoint	CKD TRIAL 3 Dialysis
	FERAHEME n=114	Oral Iron n=116
Change in Hgb Mean (SD)	1.0 g/dL* (1.1 g/dL)	0.5 g/dL (1.1 g/dL)
Change in ferritin levels Mean (SD)	233.9 ng/mL (207.0 ng/mL)	-59.2 ng/mL (106.2 ng/mL)
Change in TSAT levels Mean (SD)	6.4% (12.6%)	0.6% (8.3%)

*P≤0.001 for main efficacy endpoint.

FERAHEME demonstrated increases in Hgb, ferritin, and TSAT levels in patients with CKD²

Study design: FERAHEME was evaluated in 3 randomized clinical trials in which 605 patients were exposed to two injections of 510 mg of FERAHEME administered as a rapid intravenous injection (prior method of administration that is no longer approved); 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. The major trial outcomes assessed the change in hemoglobin from baseline to Day 35. CKD Trial 1 and 2 enrolled patients with non-dialysis-dependent CKD and CKD Trial 3 enrolled patients who were undergoing hemodialysis.²

CKD=chronic kidney disease; Hgb=hemoglobin; SD=standard deviation; TSAT=transferrin saturation.

See head-to-head clinical trial data vs Injectafer^® (ferric carboxymaltose)

Kidney disease: Improving Global Outcomes guidelines recommend IV iron administration for hemodialysis patients, and either oral or IV iron for patients in CKD stages 1 to 5 who are anemic.⁹

FERAHEME demonstrated efficacy in patients with iron deficiency anemia (IDA) caused by a variety of underlying conditions^3-5*

Prespecified subgroups of patients with IDA caused by underlying conditions were included in the FERAHEME clinical trials^3-5*

Underlying condition subgroup	IDA TRIAL 1 FERAHEME vs placebo (N=808)	IDA TRIAL 2 FERAHEME vs Venofer^® (N=605)	IDA TRIAL 3 FERAHEME vs Injectafer^® (N=1997)
AUB	42.6^% (n=344)	45.3^% (n=274)	24.6^% (n=491)
Cancer	4.8^% (n=39)	7.3^% (n=44)	2.3^% (n=45)
GI disorders	28.6^% (n=231)	33.7^% (n=204)	29.1^% (n=582)

*Primary underlying conditions of IDA, as attributed by the investigators. Patients may have had more than one underlying condition contributing to their IDA.¹

FERAHEME has been extensively studied in patients with IDA and chronic kidney disease,

including those who are dialysis-dependent and non-dialysis-dependent²

Refer your patients to another physician to receive FERAHEME

Download the referral form

See head-to-head clinical trial data vs Injectafer^® (ferric carboxymaltose)

The AAFP Guidelines for IDA evaluation and management recommend that patients with underlying conditions causing IDA should be treated or referred to a specialist for definitive treatment.¹¹

AAFP=American Academy of Family Physicians; AUB=abnormal uterine bleeding; GI=gastrointestinal.

Select your specialty to see how FERAHEME IV iron may benefit patients in your practice

Hematology/
Oncology

Gastroenterology

OBGYN

Nephrology

Primary Care

In a post hoc subgroup analysis of IDA Trials 1 and 2,
FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and cancer^1*

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying gastrointestinal (GI) disorders^3-5*

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying abnormal uterine bleeding (AUB)^3-5*

FERAHEME demonstrated non-inferior efficacy to Venofer^® (iron sucrose) in iron deficiency anemia (IDA) patients with chronic kidney disease (CKD)⁸

FERAHEME demonstrated efficacy in patients with iron deficiency anemia (IDA) caused by a variety of underlying conditions^3-5*

Feraheme^® (ferumoxytol injection) Important Safety Information

Feraheme^® (ferumoxytol injection) Important Safety Information

Select your specialty to see how FERAHEME IV iron may benefit patients in your practice

Hematology/Oncology

Gastroenterology

OBGYN

Nephrology

Primary Care

In a post hoc subgroup analysis of IDA Trials 1 and 2,FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and cancer1*

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying gastrointestinal (GI) disorders3-5*

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying abnormal uterine bleeding (AUB)3-5*

FERAHEME demonstrated non-inferior efficacy to Venofer® (iron sucrose) in iron deficiency anemia (IDA) patients with chronic kidney disease (CKD)8

FERAHEME demonstrated efficacy in patients with iron deficiency anemia (IDA) caused by a variety of underlying conditions3-5*

Feraheme® (ferumoxytol injection) Important Safety Information

Feraheme® (ferumoxytol injection) Important Safety Information

Hematology/
Oncology

In a post hoc subgroup analysis of IDA Trials 1 and 2,
FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and cancer^1*

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying gastrointestinal (GI) disorders^3-5*

FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying abnormal uterine bleeding (AUB)^3-5*

FERAHEME demonstrated non-inferior efficacy to Venofer^® (iron sucrose) in iron deficiency anemia (IDA) patients with chronic kidney disease (CKD)⁸

FERAHEME demonstrated efficacy in patients with iron deficiency anemia (IDA) caused by a variety of underlying conditions^3-5*

Feraheme^® (ferumoxytol injection) Important Safety Information

Feraheme^® (ferumoxytol injection) Important Safety Information