Description

Simple

An injectable iron replacement used to increase iron levels in adults with conditions such as kidney disease or in patients who cannot tolerate oral iron.

Clinical

An intravenous iron replacement product used to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD), or in patients who are unable to tolerate or who have not responded adequately to oral iron supplementation.

Overview

Ferumoxytol is an intravenously administered iron preparation indicated in the EU and the US for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD) [4].

It is comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution that may be administered at relatively high dose by rapid intravenous injection [8].

Pharmacology

Indication

This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron or have experienced an unsatisfactory response to oral iron or
who have chronic kidney disease (CKD) [FDA label].

Pharmacodynamic


The pharmacodynamic effect of ferumoxytol on hematologic indexes such as Hgb (hemoglobin), serum ferritin, and TSAT (transferrin saturation) were studied and measured as primary and secondary endpoints in clinical efficacy studies [ Read more

Mechanism of action

Feraheme (ferumoxytol) is comprised of a superparamagnetic iron oxide that is coated with a carbohydrate shell, aiding in the isolation the bioactive iron from plasma components until the iron-carbohydrate complex enters the reticuloendothelial system macrophages of the liver, spleen and the bone ma... Read more

Absorption

Bioavailability studies were not conducted as ferumoxytol has been developed for IV administration only [7].

Iron therapy dosage is individualized according to specific goals for blood iron concentrations, iron storage paramet... Read more

Protein binding

Information currently not available.

Volume of distribution

The population mean estimates for volume of distribution of the central compartment (V(1)), maximum elimination rate (V(max)), and ferumoxytol concentration at which rate of metabolism would be one-half of V(max) (K(m)) were 2.71 l, 14.3 mg/hr, and 77.5 mg/L, respectively [ Read more

Clearance

Since there is no renal clearance, ferumoxytol is safe in renal failure patients [11].One study estimated the clearance to be **0... Read more

Half life

The pharmacokinetic (PK) behavior of Feraheme has been studied in healthy subjects and in patients with stage 5D of chronic kidney disease, on hemodialysis [9].

Feraheme showed dose-dependent, capacity-limited elimi... Read more

Route of elimination

Iron can either become a component of intracellular ferritin or be transferred to erythroid precursor cells [12].

Toxicity

**Hypersensitivity**

The FDA has
Feraheme (ferumoxytol) may cause serious hypersensitivity reactions, including anaphylaxis and/or anaphylactoid reactions. Serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects administered Feraheme. Some other reactions potentially asso... Read more

Adverse Effects

Contraindications

Information currently not available.

Food Interactions

    Information currently not available.

Interactions

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  • Paracetamol(acetaminophen)
  • Paxil(paroxetine)
  • Pamelor(nortriptyline)
  • Panadol(acetaminophen)
  • Patanol(olopatadine ophthalmic)
  • Pataday(olopatadine ophthalmic)
  • Parnate(tranylcypromine)
  • Pazeo(olopatadine ophthalmic)
3-Aza-2,3-Dihydrogeranyl Diphosphate
Ferumoxytol can cause a decrease in the absorption of 3-Aza-2,3-Dihydrogeranyl Diphosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Calcium Phosphate
Ferumoxytol can cause a decrease in the absorption of Calcium Phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Calcium phosphate dihydrate
Ferumoxytol can cause a decrease in the absorption of Calcium phosphate dihydrate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Carbidopa
Ferumoxytol can cause a decrease in the absorption of Carbidopa resulting in a reduced serum concentration and potentially a decrease in efficacy.
Cinoxacin
Ferumoxytol can cause a decrease in the absorption of Cinoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ciprofloxacin
Ferumoxytol can cause a decrease in the absorption of Ciprofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Deferiprone
The serum concentration of Deferiprone can be decreased when it is combined with Ferumoxytol.
Delafloxacin
Ferumoxytol can cause a decrease in the absorption of Delafloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Difloxacin
Ferumoxytol can cause a decrease in the absorption of Difloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Dimercaprol
Dimercaprol may increase the nephrotoxic activities of Ferumoxytol.
Dipotassium phosphate
Ferumoxytol can cause a decrease in the absorption of Dipotassium phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Enoxacin
Ferumoxytol can cause a decrease in the absorption of Enoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Enrofloxacin
Ferumoxytol can cause a decrease in the absorption of Enrofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric pyrophosphate
Ferumoxytol can cause a decrease in the absorption of Ferric pyrophosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ferric pyrophosphate citrate
Ferumoxytol can cause a decrease in the absorption of Ferric pyrophosphate citrate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Fleroxacin
Ferumoxytol can cause a decrease in the absorption of Fleroxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Flumequine
Ferumoxytol can cause a decrease in the absorption of Flumequine resulting in a reduced serum concentration and potentially a decrease in efficacy.
Garenoxacin
Ferumoxytol can cause a decrease in the absorption of Garenoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Gatifloxacin
Ferumoxytol can cause a decrease in the absorption of Gatifloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Gemifloxacin
Ferumoxytol can cause a decrease in the absorption of Gemifloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
17 References
  1. 1 . Neuwelt EA, Varallyay CG, Manninger S, Solymosi D, Haluska M, Hunt MA, Nesbit G, Stevens A, Jerosch-Herold M, Jacobs PM, Hoffman JM: The potential of ferumoxytol nanoparticle magnetic resonance imaging, perfusion, and angiography in central nervous system malignancy: a pilot study. Neurosurgery. 2007 Apr;60(4):601-11; discussion 611-2.PubMed: 17415196
  2. 2 . Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK: Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. Epub 2005 Jul 28.PubMed: 16088081
  3. 3 . Schwenk MH: Ferumoxytol: a new intravenous iron preparation for the treatment of iron deficiency anemia in patients with chronic kidney disease. Pharmacotherapy. 2010 Jan;30(1):70-9. doi: 10.1592/phco.30.1.70.PubMed: 20030475
  4. 4 . McCormack PL: Ferumoxytol: in iron deficiency anaemia in adults with chronic kidney disease. Drugs. 2012 Oct 22;72(15):2013-22. doi: 10.2165/11209880-000000000-00000.PubMed: 22994536
  5. 5 . Feraheme Product Info Link
  6. 6 . FDA Orders Stricter Warnings for Ferumoxytol (Feraheme ) Link
  7. 7 . EMA label Link
  8. 8 . Ferumoxytol Link
  9. 9 . Ferumoxytol pubChem Link
  10. 10 . Plasma Pharmacokinetics of Two Consecutive Doses of Ferumoxytol in Healthy Subjects Link
  11. 11 . Comparative analysis of ferumoxytol and gadoteridol enhancement using T1- and T2-weighted MRI in neuroimaging Link
  12. 12 . Ferumoxytol, Davisplus Link
  13. 13 . Ferumoxytol-Enhanced Magnetic Resonance Imaging in Late-Stage CKD Link
  14. 14 . Feraheme-ferumoxytol Link
  15. 15 . Cardiovascular magnetic resonance T2* for tissue iron assessment in the heart Link
  16. 16 . T1 and T2 images, Radiology Masterclass Link
  17. 17 . Feraheme PDR Link