Feraheme (ferumoxytol)

Company
AMAG

Approval Status
Approved June 2009

Treatment for
iron deficiency anemia associated with chronic kidney disease

Areas
Hematology , Urology & Kidneys

Feraheme is a superparamagnetic iron oxide nanoparticle coated with a low molecular weight semi-synthetic carbohydrate. It helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

Feraheme is specifically indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease.

Feraheme is supplied as a solution for intravenous injection. The recommended initial dose is a 510 mg intravenous injection followed by a second 510 mg intravenous injection 3 to 8 days later. Feraheme should be administered as an undiluted intravenous injection delivered at a rate of up to 1 mL/sec (30 mg/sec). For patients receiving hemodialysis, administer Feraheme once the blood pressure is stable and the patient has completed at least one hour of hemodialysis.

FDA Approval
The FDA approval of Feraheme was based on three randomized, open-label, controlled clinical trials. In all three trials, subjects were randomized to treatment with Feraheme, administered as two 510 mg intravenous single doses, or oral iron (ferrous fumarate), administered as a total daily dose of 200 mg elemental iron daily for 21 days. The major trial outcomes assessed the change in hemoglobin from baseline to Day 35. Trial Oneenrolled 303 subjects with non-dialysis dependent CKD; Trial Two enrolled 304 subjects with non-dialysis dependent CKD; Trial Three enrolled 230 subjects who were undergoing hemodialysis. Feraheme reached the primary endpoint with statistical significance (p<0.001) in all three trials versus oral iron.

An uncontrolled, follow-up trial was also conducted during which subjects with persistent iron deficiency anemia could receive two additional 510 mg intravenous injections of Feraheme, for a total cumulative dose of 2.04 g. Overall, 69 subjects received the additional injections of Feraheme, and on Day 35 following these additional injections, the majority of these patients (70%) experienced an increase in hemoglobin and iron parameters (TSAT and ferritin). The mean change in hemoglobin level from the retreatment baseline for patients with an increase in hemoglobin was 0.86 (± 0.68) g/dL and was 0.5 (± 0.8) g/dL for all patients.

Ongoing Study Commitments

  • AMAG has agreed to conduct a clinical trial in pediatric patients aged 2 to < 18 years who have iron deficiency anemia and who are receiving either hemodialysis or peritoneal dialysis. In addition to any other items, the trial will obtain pharmacokinetic (PK), pharmacodynamic (PD) and safety data from at least 50 patients exposed to ferumoxytol. In this trial, patients will be randomized to oral iron (25 patients) or one of two dose ferumoxytol dose regimens (25 patients in each dose cohort). Endpoints will consist of PK, PD, comparisons of hemoglobin changes and safety summaries.
    Final clinical protocol submission date: December 2009
    Clinical trial completion date: April 2013
    Final trial report submission date: October 2013
  • AMAG has agreed to conduct a clinical trial in pediatric patients aged 2 to 18 years who have iron deficiency anemia and chronic kidney disease that does not require dialysis. In addition to any other items, the trial will obtain pharmacokinetic (PK), pharmacodynamic (PD) and safety data from at least 50 patients exposed to ferumoxytol. In this trial, patients will be randomized to oral iron (25 patients) or one of two dose ferumoxytol dose regimens (25 patients in each dose cohort). Endpoints will consist of PK, PD, comparisons of hemoglobin changes and safety summaries.
    Final clinical protocol submission date: December 2009
    Clinical trial completion date: April 2013
    Final trial report submission date: October 2013

Adverse events associated with the use of Feraheme may include, but are not limited to, the following:

  • diarrhea
  • nausea
  • dizziness
  • hypotension
  • constipation
  • peripheral edema

Feraheme is a superparamagnetic iron oxide nanoparticle coated with a low molecular weight semi-synthetic carbohydrate. It helps to isolate the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and bone marrow. The iron is released from the iron-carbohydrate complex within vesicles in the macrophages. Iron then either enters the intracellular storage iron pool (e.g., ferritin) or is transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into hemoglobin.

For additional information regarding Feraheme or iron deficiency anemia associated with chronic kidney disease, please visit the Feraheme web page.

Feraheme Drug Information

The Feraheme drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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