Feraheme Efficacy in NDD-CKD

Raise Hgb and iron stores in NDD-CKD¹

The efficacy of Feraheme was evaluated in 2 randomized, active-controlled, open-label pivotal trials in which 303 non-dialysis dependent chronic kidney disease (NDD-CKD) patients Stages 1 to 5 (Trial 1) and 304 NDD-CKD patients Stages 1 to 5 (Trial 2) were randomized 3:1 to treatment with Feraheme or oral iron.

• Feraheme was administered as two 510-mg IV single doses, and most patients received their second Feraheme injection 3 to 8 days after the first injection; oral iron (ferrous fumarate) was administered as a total daily dose of 200 mg elemental iron daily for 21 days.^1,2
• In both pivotal trials, Feraheme was significantly more effective than oral iron in raising hemoglobin (Hgb) and transferrin saturation (TSAT)^1,2

• In both pivotal trials, a 1.02-gram treatment course of Feraheme (2 x 510 mg) provided an approximate 1-gram increase in Hgb vs treatment with oral iron

Proven to significantly increase Hgb and TSAT in 2 NDD-CKD pivotal trials^1,2

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

• Mean change in serum ferritin for Feraheme-treated patients (ng/mL) from baseline of 123.7 (SD=±125.4)
  was 300.7 (SD±214.9) at Day 35 ^1,b

Trial 2: Mean change in Hgb and TSAT from baseline at Day 35 in NDD-CKD patients^1,a

• Mean change in serum ferritin for Feraheme-treated patients (ng/mL) from baseline of 146.1 (SD=±173.6)
  was 381.7 (SD±278.6) 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 2 randomized, active-controlled, open-label pivotal trials in which 303 NDD-CKD patients Stages 1 to 5 (Trial 1) and 304 NDD-CKD patients Stages 1 to 5 (Trial 2) were randomized 3:1 to treatment with Feraheme or oral iron. Feraheme was administered as two 510-mg IV single doses; most patients received their second Feraheme injection 3 to 8 days after the first injection. Oral iron (ferrous fumarate) was 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 1 and Trial 2.²

The efficacy of Feraheme with and without erythropoiesis stimulating agent (ESA) therapy was also evaluated in a randomized, controlled pivotal trial.

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.