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Ferumoxytol

Class: Iron Preparations
VA Class: TN410
Molecular Formula: Fe5874O8752C11719H18682O9933Na414
CAS Number: 1309-38-2
Brands: Feraheme

Warning(s)

Special Alerts:

[Posted 03/31/2015] ISSUE: FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug ferumoxytol (Feraheme). FDA changed the prescribing instructions and approved a Boxed Warning, FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of ferumoxytol in patients who have had an allergic reaction to any intravenous (IV) iron replacement product.

All IV iron products carry a risk of potentially life-threatening allergic reactions. At the time of ferumoxytol’s approval in 2009, this risk was described in the Warnings and Precautions section of the drug label. Since then, serious reactions, including deaths, have occurred despite the proper use of therapies to treat these reactions and emergency resuscitation measures (see Drug Safety Communication/Data Summary at: ). FDA evaluated this risk further and has identified ways to reduce the risk of serious allergic reactions with ferumoxytol.

FDA is continuing to monitor and evaluate the risk of serious allergic reactions with all IV iron products, and we will update the public as new information becomes available.

BACKGROUND: Ferumoxytol is in a class of medicines called IV iron replacement products. It is used to treat iron-deficiency anemia, a condition in which there is a lower than normal number of oxygen-carrying red blood cells because of too little iron. Ferumoxytol is specifically approved for use only in adults with iron deficiency anemia in patients with chronic kidney disease.

RECOMMENDATIONS: Based on FDAs evaluation, the prescribing instructions and other label information were updated, adding a Boxed Warning that describes these serious risks and recommending that health care professionals:

  • Only administer IV iron products to patients who require IV iron therapy.

  • Do not administer ferumoxytol to patients with a history of allergic reaction to ferumoxytol or other IV iron products.

  • Only administer diluted ferumoxytol as an IV infusion over a minimum of 15 minutes. Ferumoxytol should not be given as an undiluted IV injection.

  • Closely monitor patients for signs and symptoms of serious allergic reactions, including monitoring blood pressure and pulse during ferumoxytol administration and for at least 30 minutes following each infusion.

  • Carefully consider the potential risks and benefits of ferumoxytol administration in elderly patients with multiple or serious medical conditions, as these patients may experience more severe reactions.

  • Carefully consider the potential risks and benefits of ferumoxytol administration in patients with a history of multiple drug allergies. Patients with multiple drug allergies may also be at higher risk.

For more information visit the FDA website at: and .

Warning(s)

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Introduction

Hematinic agent: a superparamagnetic iron oxide nanoparticle with a polyglucose sorbitol carboxymethylether coating.1 2 3

Uses for Ferumoxytol

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Iron Deficiency Anemia in Patients with Chronic Kidney Disease

Treatment of iron deficiency anemia in adults with chronic kidney disease (CKD).1 2 3

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National Kidney Foundation guidelines recommend use of IV iron in patients undergoing hemodialysis and either oral or IV iron in patients undergoing peritoneal dialysis and in those with chronic kidney disease not on dialysis.4

Ferumoxytol Dosage and Administration

General

Goal of iron therapy in patients with chronic renal failure not undergoing dialysis or undergoing peritoneal dialysis is to achieve and maintain a transferrin saturation (TSAT) of >20% and a serum ferritin concentration of >100 ng/mL.4

Goal of iron therapy in patients with chronic renal failure undergoing hemodialysis is to achieve and maintain a TSAT of >20% (or content of hemoglobulin in reticulocytes [CHr] >29 pg/cell) and a serum ferritin concentration of >200 ng/mL.4

Evaluate hematologic response (e.g., serum ferritin concentration, hemoglobin level, iron and transferrin saturation) at least one month after the second dose of ferumoxytol.1

Monitor for hypersensitivity reactions for at least 30 minutes after each injection.1 Appropriate agents and personnel for the treatment of hypersensitivity reactions should be readily available.1

Monitor for hypotension.1

Administration

IV Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Administer undiluted by IV injection.1

Hemodialysis patients: Administer after first hour of dialysis, when patient is hemodynamically stable.1

Rate of Administration

1 mL/second.1

Dosage

Dosage expressed in terms of mg of elemental iron.1 Ferumoxytol injection contains the equivalent of 30 mg of elemental iron per mL.1

Adults

Iron Deficiency Anemia in Patients with Chronic Kidney Disease
IV

Initial dose is 510 mg; second dose is 510 mg administered 3–8 days after initial dose.1

Course of ferumoxytol may be repeated.1

Special Populations

Geriatric Patients

Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1

Cautions for Ferumoxytol

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Known hypersensitivity to ferumoxytol or any ingredient in the formulation.1

  • Evidence of iron overload.1

  • Anemias not associated with iron deficiency.1

Warnings/Precautions

Sensitivity Reactions

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Hypersensitivity reactions (e.g., anaphylaxis, anaphylactoid reactions) reported; serious reactions reported in 0.2% of patients; other potential hypersensitivity reactions (e.g., pruritus, rash, urticaria, wheezing) reported in 3.7% of patients.1 Monitor patient for hypersensitivity reactions for at least 30 minutes after each injection.1

Cardiovascular Effects

Hypotension reported in 1.9% of patients; serious hypotensive reactions reported in a few patients.1 Monitor patient for hypotension.1

Iron Toxicity

Withhold iron administration in patients with evidence of iron overload.1 Excessive administration of parenteral iron preparations may cause excess storage of iron with the possibility of iatrogenic hemosiderosis.1

Evaluate hematologic response at least 1 month after second dose.1 Laboratory assays may overestimate serum iron and transferrin-bound iron in the 24 hours following injection of ferumoxytol.1

Magnetic Resonance Imaging

May temporarily affect magnetic resonance imaging (MRI) studies; alteration in MRI studies may persist for up to 3 months after the last dose of ferumoxytol.1

Schedule MRI studies before administration of ferumoxytol.1 If MRI studies are needed within 3 months of ferumoxytol administration, use of T1- or proton density-weighted pulse sequences minimizes the effects of the drug.1 Do not perform MRI studies using T2-weighted pulse sequences earlier than 4 weeks after drug administration.1 Maximum alteration in vascular MRI studies is expected for 1–2 days following drug administration.1

Does not interfere with radiography, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), ultrasound, or nuclear imaging.1

Specific Populations

Pregnancy

Category C.1

Lactation

Not know whether ferumoxytol is distributed into human milk.1 Discontinue nursing or the drug, taking into account the importance of the drug to the woman and the benefits of nursing.1

Pediatric Use

Safety and efficacy not established in pediatric patients.1

Geriatric Use

No overall differences in efficacy or safety relative to younger adults; possibility of increased sensitivity cannot be ruled out.1 Use caution in dosage selection.1 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Diarrhea, nausea, dizziness, hypotension, constipation, peripheral edema.1

Interactions for Ferumoxytol

No formal drug interaction studies to date.1

Oral Iron Preparations

Ferumoxytol injection expected to reduce absorption of concomitantly administered oral iron.1

Ferumoxytol Pharmacokinetics

Absorption

Bioavailability

Time to peak plasma concentrations is 0.32 hours.1

Elimination

Elimination Route

Not removed by dialysis.1 3

Half-life

15 hours.1

Stability

Storage

Parenteral

Injection

20–25°C (may be exposed to 15–30°C).1

Actions

  • Ferumoxytol is taken up by the reticuloendothelial system.1 Subsequently, iron is released from ferumoxytol into macrophages.1 Iron enters the intracellular storage pool or is bound to plasma transferrin for transport to erythroid precursor cells where it is incorporated into hemoglobin.1

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Risk of hypersensitivity reactions.1

  • Risk of hypotension.1

  • Importance of informing clinician of prior hypersensitivity reactions to parenteral iron preparations.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ferumoxytol

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IV use

equivalent to elemental iron 30 mg/mL

Feraheme

AMAG Pharmaceuticals

AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions April 1, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. AMAG Pharmaceuticals. Feraheme (ferumoxytol) injection prescribing information. Lexington, MA; 2009 Jun.

2. Spinowitz BS, Kausz AT, Baptista J et al. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008; 19:1599-1605. [PubMed 18525001]

3. Provenzano R, Schiller B, Rao M et al. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009; 4:386-93. [PubMed 19176796]

4. National Kidney Foundation. K/DOQI clinical practice guidelines and clinical practice recommendations for anemia of chronic kidney disease. Am J Kidney Dis. 2006; 47 (Suppl 3);S1-S146.

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