Feraheme Information
Feraheme (Ferumoxytol) Indications And Usage
Feraheme (Ferumoxytol) is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).
Feraheme (Ferumoxytol) Dosage And Administration
The recommended dose of Feraheme (Ferumoxytol) is an initial 510 mg intravenous injection followed by a second 510 mg intravenous injection 3 to 8 days later. Administer Feraheme (Ferumoxytol) as an undiluted intravenous injection delivered at a rate of up to 1 mL/sec (30 mg/sec). The dosage is expressed in terms of mg of elemental iron, with each mL of Feraheme (Ferumoxytol) containing 30 mg of elemental iron. Evaluate the hematologic response (hemoglobin, ferritin, iron and transferrin saturation) at least one month following the second Feraheme (Ferumoxytol) injection. The recommended Feraheme (Ferumoxytol) dose may be readministered to patients with persistent or recurrent iron deficiency anemia.
For patients receiving hemodialysis, administer Feraheme (Ferumoxytol) once the blood pressure is stable and the patient has completed at least one hour of hemodialysis. Monitor for signs and symptoms of hypotension following each Feraheme (Ferumoxytol) injection.
Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration.
Feraheme (Ferumoxytol) Dosage Forms And Strengths
Feraheme (Ferumoxytol) (30 mg/mL) is available for intravenous injection in single use vials. Each vial contains 510 mg of elemental iron in 17 mL.
Feraheme (Ferumoxytol) Contraindications
Feraheme (Ferumoxytol) is contraindicated in patients with:
• Known hypersensitivity to Feraheme (Ferumoxytol) or any of its components
Feraheme (Ferumoxytol) Warnings And Precautions
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Feraheme (Ferumoxytol) . Observe patients for signs and symptoms of hypersensitivity during and after Feraheme (Ferumoxytol) administration for at least 30 minutes and until clinically stable following completion of each administration. Only administer the drug when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions []. Anaphylactic type reactions presenting with cardiac/cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported in the post-marketing experience
Severe adverse reactions of clinically significant hypotension have been reported.
Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy []. Do not administer Feraheme (Ferumoxytol) to patients with iron overload.
In the 24 hours following administration of Feraheme (Ferumoxytol) , laboratory assays may overestimate serum iron and transferrin bound iron by also measuring the iron in the Feraheme (Ferumoxytol) complex.
Administration of Feraheme (Ferumoxytol) may transiently affect the diagnostic ability of MR imaging. Anticipated MR imaging studies should be conducted prior to the administration of Feraheme (Ferumoxytol) . Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme (Ferumoxytol) dose. If MR imaging is required within 3 months after Feraheme (Ferumoxytol) administration, use T1- or proton density-weighted MR pulse sequences to minimize the Feraheme (Ferumoxytol) effects; MR imaging using T2-weighted pulse sequences should not be performed earlier than 4 weeks after the administration of Feraheme (Ferumoxytol) . Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme (Ferumoxytol) administration [].
Feraheme (Ferumoxytol) will not interfere with X-ray, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound or nuclear medicine imaging.
Feraheme (Ferumoxytol) Adverse Reactions
Feraheme (Ferumoxytol) injection may cause serious hypersensitivity reactions and hypotension [].
In clinical studies, 1,726 subjects were exposed to Feraheme (Ferumoxytol) ; 1,562 of these had CKD and 164 did not have CKD. Of these subjects 46% were male and the median age was 63 years (range of 18 to 96 years).
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug may not reflect the rates observed in practice.
Feraheme (Ferumoxytol) Drug Interactions
Drug-drug interaction studies with Feraheme (Ferumoxytol) were not conducted. Feraheme (Ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations.
Feraheme (Ferumoxytol) Use In Specific Populations
Pregnancy Category C
There are no studies of Feraheme (Ferumoxytol) in pregnant women. In animal studies, ferumoxytol caused fetal malformations and decreased fetal weights at maternally toxic doses of 6 times the estimated human daily dose. Use Feraheme (Ferumoxytol) during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Administration of ferumoxytol during organogenesis, at doses of 31.6 mg Fe/kg/day in rats and 16.5 mg Fe/kg/day in rabbits, did not result in maternal or fetal effects. These doses are approximately 2 times the estimated human daily dose based on body surface area. In rats, administration of ferumoxytol during organogenesis at a maternally toxic dose of 100 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, caused a decrease in fetal weights. In rabbits, administration of ferumoxytol during organogenesis at a maternally toxic dose of 45 mg Fe/kg/day, approximately 6 times the estimated human daily dose based on body surface area, was associated with external and/or soft tissue fetal malformations and decreased fetal weights.
Feraheme (Ferumoxytol) Overdosage
No data are available regarding overdosage of Feraheme (Ferumoxytol) in humans. Excessive dosages of Feraheme (Ferumoxytol) may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Feraheme (Ferumoxytol) to patients with iron overload [].
Feraheme (Ferumoxytol) Description
Feraheme (Ferumoxytol) , an iron replacement product, is a non-stoichiometric magnetite (superparamagnetic iron oxide) coated with polyglucose sorbitol carboxymethylether. The overall colloidal particle size is 17-31 nm in diameter. The chemical formula of Feraheme (Ferumoxytol) is FeO-CHONa with an apparent molecular weight of 750 kDa.
Feraheme (Ferumoxytol) injection is an aqueous colloidal product that is formulated with mannitol. It is a black to reddish brown liquid, and is provided in single use vials containing 510 mg of elemental iron. Each mL of the sterile colloidal solution of Feraheme (Ferumoxytol) injection contains 30 mg of elemental iron and 44 mg of mannitol, and has low bleomycin-detectable iron. The formulation is isotonic with an osmolality of 270-330 mOsm/kg. The product contains no preservatives, and has a pH of 6 to 8.
Feraheme (Ferumoxytol) Clinical Pharmacology
Cardiac Electrophysiology
Feraheme (Ferumoxytol) Clinical Studies
The safety and efficacy of Feraheme (Ferumoxytol) for the episodic treatment of iron deficiency anemia in patients with CKD were assessed in three randomized, open-label, controlled clinical trials (Trial 1, 2 and 3). These trials also included an uncontrolled, follow-up phase in which patients with persistent iron deficiency anemia could receive two additional 510 mg intravenous injections of Feraheme (Ferumoxytol) . The major efficacy results from the controlled phase of each study are shown in Table 2.
In all three trials, patients with CKD and iron deficiency anemia were randomized to treatment with Feraheme (Ferumoxytol) or oral iron. Feraheme (Ferumoxytol) was administered as two 510 mg intravenous single doses and oral iron (ferrous fumarate) was 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 1 and 2 enrolled patients with non-dialysis dependent CKD and Trial 3 enrolled patients who were undergoing hemodialysis.
In Trial 1, the mean age of patients was 66 years (range, 23 to 95); 60% were female; 65% were Caucasian, 32% were Black, and 2% were other races. In the Feraheme (Ferumoxytol) and oral iron groups, 42% and 44% of patients, respectively, were receiving erythropoiesis stimulating agents (ESAs) at baseline.
In Trial 2, the mean age of patients was 65 years (range, 31 to 96); 61% were female; 58% were Caucasian, 35% were Black, and 7% were other races. In the Feraheme (Ferumoxytol) and oral iron groups, 36% and 43% of patients, respectively, were receiving ESAs at baseline.
In Trial 3, the mean age of patients was 60 years (range, 24 to 87); 43% were female; 34% were Caucasian, 59% were Black, and 7% were other races. All patients were receiving ESAs.
Table 2 shows the Baseline and mean change to Day 35 in hemoglobin (Hgb, g/dL), transferrin saturation (TSAT, %) and ferritin (ng/mL) in each treatment group for Trial 1, 2, and 3.
Following completion of the controlled phase of each of the Phase 3 trials, patients who were iron deficient and anemic could receive two additional 510 mg intravenous injections of Feraheme (Ferumoxytol) for a total cumulative dose of 2.04 g. Overall, 69 patients received two additional 510 mg intravenous injections of Feraheme (Ferumoxytol) , 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 (±SD) 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.
Feraheme (Ferumoxytol) Patient Counseling Information
Prior to Feraheme (Ferumoxytol) administration:
Manufactured and Distributed by:
AMAG Pharmaceuticals Inc.Lexington, MA 02421
Feraheme (Ferumoxytol)
Feraheme (Ferumoxytol)
