Feraheme Efficacy With or Without ESAs

Effective in NDD-CKD independent of ESA use¹

The efficacy of Feraheme with and without erythropoiesis stimulating agents (ESAs) was demonstrated in two identical randomized, active-controlled, open-label pivotal trials (Trial 1 and Trial 2) evaluating non-dialysis dependent chronic kidney disease (NDD-CKD) patients. In both trials, Feraheme significantly improved Hgb compared with oral iron regardless of concurrent ESA therapy. More specifically, in Trial 2, 304 NDD-CKD patients Stages 1 to 5 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 In Trial 2:

• 36% and 43% of patients, respectively, in the Feraheme and oral iron groups were on ESAs at baseline²
• Feraheme delivered significantly higher increases in hemoglobin (Hgb) from baseline at Day 35 both for patients on ESAs and for patients not on ESAs¹

Mean change in Hgb from baseline at Day 35 by ESA use in NDD-CKD patients^1,a,b

SD=standard deviation.

^a As demonstrated in a randomized, active-controlled, open-label pivotal trial in which 304 NDD-CKD patients Stages 1 to 5 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. The results of Trial 1 were similar and also significant.²

^b Hgb was the primary efficacy endpoint in Trial 2.¹

Now that you’ve seen how Feraheme performed with or without ESAs in NDD-CKD, see how Feraheme performed in dialysis dependent CKD (DD-CKD).

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.