Feraheme Efficacy in DD-CKD

Improve Hgb and iron status in DD-CKD¹

The efficacy of Feraheme was evaluated in a randomized, active-controlled, open-label, pivotal trial—Trial 3—in which 230 hemodialysis dependent chronic kidney disease (HDD-CKD) patients were randomized 1:1 to Feraheme administered as two 510-mg IV single doses or oral iron (ferrous fumarate) administered as a total daily dose of 200 mg elemental iron daily for 21 days.² In this trial:

• Oral iron was used as a control in pivotal trials for other IV irons; ferrous fumarate was selected as the oral iron control for its favorable tolerability profile^7-10

• Feraheme was shown to be significantly more effective than oral iron in raising hemoglobin (Hgb) and transferrin saturation (TSAT) in dialysis dependent CKD (DD-CKD) patients¹

Take Hgb and TSAT to a significantly higher level
in DD-CKD^1,2

Mean change in Hgb and TSAT from baseline at Day 35 in HDD-CKD patients^1,a

• Mean change in serum ferritin (ng/mL) for Feraheme-treated patients from baseline of 340.5 (SD=±159.1)
  was 233.9 (SD=±207.0) at Day 35^1,b

SD=standard deviation.

The analysis was done on the intent-to-treat (ITT) population in the above charts.²

^a As demonstrated in a randomized, active-controlled, open-label pivotal trial in which 230 HDD-CKD patients were randomized 1:1 to Feraheme administered as two 510-mg IV single doses or oral iron (ferrous fumarate) administered as a total daily dose of 200 mg elemental iron daily for 21 days.^{1, 2}

^b TSAT and serum ferritin were additional efficacy endpoints in Trial 3.²

How does Feraheme increase Hgb and iron levels? See the Feraheme mechanism of action.

Important Safety Information

Indication and contraindications

Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Feraheme is contraindicated in patients with evidence of iron overload, known hypersensitivity to Feraheme or any of its components, and patients with anemia not caused by iron deficiency.

Warnings and precautions

In clinical studies, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of subjects. Patients should be observed for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and the drug should only be administered when personnel and therapies are readily available for the treatment of hypersensitivity reactions. 1.9% (33/1,726) of Feraheme-treated subjects experienced hypotension. Please monitor for signs and symptoms of hypotension following each Feraheme injection. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme. As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.

Adverse reactions

In clinical trials, the most commonly occurring adverse reactions in Feraheme treated patients versus oral iron treated patients reported in ≥2% of chronic kidney disease patients were diarrhea (4.0% vs. 8.2%), nausea (3.1% vs. 7.5%), dizziness (2.6% vs. 1.8%), hypotension (2.5% vs. 0.4%), constipation (2.1% vs. 5.7%) and peripheral edema (2.0% vs. 3.2%). In clinical trials, adverse reactions leading to treatment discontinuation and occurring in 2 or more Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.

Please see full Prescribing Information for Feraheme.