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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*
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.
FERAHEME demonstrated efficacy in increasing Hgb rates in patients with iron deficiency anemia (IDA) and underlying gastrointestinal (GI) disorders3-5*
In IDA Trials 1 and 2, approximately 31% of patients treated with FERAHEME had IDA caused by underlying GI disorders3,4
IDA TRIAL 1 STUDY DESIGN
The efficacy and safety 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, double-blind, placebo-controlled clinical trial (IDA Trial 1) with FERAHEME administered as a rapid intravenous injection (prior method of administration that is no longer approved).2
In IDA Trial 1, patients were randomized to treatment with FERAHEME or placebo.2
IDA=iron deficiency anemia.
IDA TRIAL 2 STUDY DESIGN
The safety and efficacy of FERAHEME in adult patients with IDA, 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). Patients were randomized to: two injections (rapid intravenous injection—prior method of administration no longer approved) of 510 mg of FERAHEME, or five injections/infusions of 200 mg of iron sucrose.2
Primary endpoint:Proportion of patients with Hgb increase of ≥2 g/dL at any time from baseline to Week 5.4
Secondary endpoint: Mean change in Hgb from baseline to Week 5 (SD), g/dL.4
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 AUB3,4
IDA Trial 1 Study Design
The efficacy and safety 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, double-blind, placebo-controlled clinical trial (IDA Trial 1) with FERAHEME administered as a rapid intravenous injection (prior method of administration that is no longer approved).2
In IDA Trial 1, patients were randomized to treatment with FERAHEME or placebo.2
IDA=iron deficiency anemia.
IDA TRIAL 2 STUDY DESIGN
The safety and efficacy of FERAHEME in adult patients with IDA, 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). Patients were randomized to: two injections (rapid intravenous injection—prior method of administration no longer approved) of 510 mg of FERAHEME, or five injections/infusions of 200 mg of iron sucrose.2
Primary endpoint:Proportion of patients with Hgb increase of ≥2 g/dL at any time from baseline to Week 5.4
Secondary endpoint: Mean change in Hgb from baseline to Week 5 (SD), g/dL.4
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.
CKD TRIAL STUDY DESIGN
A randomized, open-label, multicenter clinical trial of 162 patients with IDA and CKD compared the efficacy and safety of FERAHEME vs iron sucrose. FERAHEME was administered as two 510-mg injections (prior method of administration that is no longer approved) for a total dose of 1.02 g. 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).2,8,10
Primary endpoint: Mean change in Hgb from baseline to Week 5.8
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 CKD2,8
0.71g/dL
±1.03
FERAHEME (n=80)
0.61g/dL
±0.97
Venofer®(n=82)
0.1g/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.
FERAHEME SIGNIFICANTLY INCREASED MEAN CHANGE IN Hgb FROM BASELINE VS ORAL IRON2
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
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 conditions3-5*
Prespecified subgroups of patients with IDA caused by underlying conditions were included in the FERAHEME clinical trials3-5*
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
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.
