About Feraheme

Feraheme is approved for the treatment of iron deficiency anemia (IDA) in adult patients with chronic kidney disease (CKD)¹

• 510-mg undiluted IV push that may be delivered in under 1 minute¹
• Deliver at a rate of up to 1 mL/sec (30 mg/sec)¹
• Second dose should be delivered 3 to 8 days after the first dose¹
• Proven safety in both non-dialysis dependent chronic kidney disease (NDD-CKD) patients and dialysis dependent CKD (DD-CKD) patients¹
• Significantly increased hemoglobin (Hgb) and transferrin saturation (TSAT) across the spectrum of CKD^1,2,a

^a Hgb was the primary efficacy endpoint and TSAT was an additional efficacy endpoint in 3 randomized, open-label, controlled clinical trials.²

Feraheme—a unique IV iron formulation

Feraheme consists of bioavailable iron oxide surrounded by a carbohydrate shell composed of polyglucose sorbitol carboxymethylether (PSC)¹:

• Iron oxide and PSC form a complex
• This stable complex isolates iron oxide until it is broken down by macrophages of the reticuloendothelial system
• Iron is then absorbed or stored by the body, while the carbohydrate shell is excreted

To see how PSC is designed to function in the body, view 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.