Safety in CKD

Established safety across all stages of CKD^1,2

The safety of Feraheme has been evaluated in 1726 subjects across 11 clinical studies, including 1562 chronic kidney disease (CKD) patients in 7 clinical studies^1,2

• Studies in CKD patients consisted of 938 non-dialysis dependent CKD (NDD-CKD) patients, 581 hemodialysis dependent CKD (HDD-CKD) patients, and 43 peritoneal dialysis dependent CKD (PDD-CKD) patients

Adverse reactions reported in ≥1% of Feraheme-treated CKD patients in randomized, active-controlled, open-label studies^1,a

• In randomized clinical trials involving patients treated with Feraheme vs patients treated with oral iron, diarrhea (4.0% vs 8.2%), constipation (2.1% vs 5.7%), and hypertension (1.0% vs 0.7%) were also reported^1,2

^a Evaluated in 3 randomized clinical trials in which 605 CKD patients were exposed to 2 injections of 510 mg of Feraheme and 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.¹

For more details about the safety of Feraheme, please see Feraheme Prescribing Information.

When considering the safety of Feraheme in CKD, it is particularly important to note the incidence of hypersensitivity/hypotension.

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.