Ferumoxytol 510mg/17ml solution for infusion vials
Ferumoxytol is an intravenously administered iron preparation previously indicated in the EU and the US for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD) [A32478].
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Suspected adverse reactions reported for Ferumoxytol
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Suspected adverse reactions reported for Ferumoxytol
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1 branded products available
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Ferumoxytol
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
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Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
15 hours
Mechanism
Feraheme (ferumoxytol) is comprised of a superparamagnetic iron oxide that is co…
Food interactions
None known
Human targets
None mapped
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
[L2179]
Iron…
Half-life
15 hours
[L2182]
Feraheme…
Volume of distribution
2.71 l
Metabolism
90%
[L2186]…
Elimination
[L2185]
Clearance
0.0221 L/h
[L2184]
One…
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
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 [L2181].
[L54496]
Under the brand name Ferabright in the US, it is indicated for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant neoplasms in the brain to visualize lesions with a disrupted bloodbrain barrier.
[L54506]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 55 interactions
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 associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects.
It is necessary to monitor patients for signs and symptoms of hypersensitivity for at least 30 minutes following Feraheme injection and limit administration of the drug only to when personnel and therapies are readily available for the treatment of hypersensitivity reactions .
[L54496]
Ferumoxytol was not tested for carcinogenic effects. In general genotoxicity tests, ferumoxytol showed no evidence of mutagenic activity in an in vitro Ames test or clastogenic activity in either an in vitro chromosomal aberration assay or an in vivo micronucleus assay. No adverse effects on fertility were observed in animal studies.
Ferumoxytol had no effect on male or female fertility or general reproductive function in rats .
[L54496]
Hypotension
Feraheme may cause significant hypotension.
In a clinical study with Feraheme in patients with IDA, regardless of etiology, moderate hypotension was reported in 0.2% of subjects receiving Feraheme administered as intravenous infusion for at least 15 minutes .
[L54496]
Iron overload
Excessive therapy with parenteral iron may lead to excess storage of iron with a possibility of iatrogenic hemosiderosis. Frequently monitor the hematologic response during parenteral iron therapy. It is advised not to administer Feraheme to patients with iron overload .
[L54496]
A note on MRI studies
Administration of Feraheme may transiently affect the diagnostic ability of MR imaging.
Anticipated MR imaging studies should be done before the administration of Feraheme. Alteration of MRI imaging studies may persist for up to 12 weeks after the last Feraheme dose .
[L54496]
The iron is then released from the iron-carbohydrate complex within vesicles located in the macrophages. Iron then either enters the intracellular storage of iron (e.g., ferritin) or can be transferred to plasma transferrin for its transport to erythroid precursor cells for incorporation into hemoglobin [L54496].
A therapeutic response to iron therapy depends upon the individual's iron stores and ability to utilize the iron. The systemic use of iron is influenced by the cause of the deficiency in addition to the illnesses/conditions that may affect erythropoiesis. Iron therapy by itself does not increase red blood cell (RBC) production. Administration of iron improves only the anemia associated with iron deficiency [L2190].
Iron-containing proteins and enzymes are essential in oxidation-reduction reactions, particularly those in the mitochondria. Iron is a part of myoglobin and various heme-enzymes, including the cytochromes, catalase, and peroxidase. Iron is an important component of the _metalloflavoprotein _enzymes as well as the mitochondrial enzyme alpha-glycerophosphate oxidase. In addition, iron serves as a cofactor for enzymes such as _aconitase _and tryptophan pyrrolase. Iron deficiency leads anemia and decreased oxygen delivery, but also reduces muscle metabolism and decreases mitochondrial activity [L2190].
Iron deficiency may also lead to defects in both learning and body thermoregulation. Therefore, iron is imperative to several metabolic functions in addition to erythropoiesis [L2190].
After intravenous administration, ferumoxytol replaces iron stores with less frequent side effects compared to the use of oral iron therapy. In addition, this agent generates T1 relaxation, producing a magnetic field and enhancing T2 relaxation, thereby darkening contrast media-containing structures in magnetic resonance imaging (MRI). Due to small particle size, ferumoxytol remains in the intravascular space for a prolonged period and so may be used as a blood pool agent [L2182].
T1 and T2, in radiology, refer to the timing of radiofrequency pulse sequences used to make images. The timing used to create T1 images results in images which emphasize fat tissue. The timing of radiofrequency pulse sequences utilized to create T2 images results in images which emphasize fat AND water within the body [L2189].
Feraheme (ferumoxytol) reached the primary endpoint with statistical significance (p<0.001) in all three trials versus oral iron [L2187].
Ferumoxytol has been examined as a contrast agent for magnetic resonance imaging (MRI) studies. Because ferumoxytol is a very small superparamagnetic iron oxide (USPIO) with a polysaccharide coating, it may be administered via the intravenous bolus route without mast cell degranulation, which is an attributable property for magnetic resonance angiography and perfusion imaging. Unlike gadolinium, ferumoxytol crosses the blood-brain barrier at a slow pace and is considered a 'blood pool' agent. Ferumoxytol stays in the intravascular space and offers a longer time period for data acquisition during an MRI study so that data can be repeatedly obtained over a period of several minutes to hours with only small losses of intravascular signal intensity and minimal soft tissue enhancement [L2190].
Iron-containing proteins and enzymes are important in oxidation-reduction reactions, particularly those in the mitochondria. Iron is a part of myoglobin and several heme-enzymes, including the cytochromes, catalase, and peroxidase. Iron is an essential component of the m_etalloflavoprotein_ enzymes and the mitochondrial enzyme alpha-glycerophosphate oxidase. In addition, iron is a cofactor for enzymes such as aconitase and tryptophan pyrrolase. Iron deficiency cause anemia and decreased oxygen delivery. This also reduces the metabolism of muscle and decreases mitochondrial activity. Iron deficiency may also cause defects in both learning or thermoregulation. Therefore, iron is important to several metabolic functions in addition to erythropoiesis [L2190].
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L2179]
Iron therapy dosage is individualized according to specific goals for blood iron concentrations, iron storage parameters (e.g., ferritin, transferrin saturation), and serum hemoglobin concentrations. Iron toxicity is possible with excessive or unnecessary iron therapy. Systemic iron is stored in ferritin and hemosiderin, which are utilized for future production of hemoglobin.
The absorption of iron depends on the route of administration. The tissue that first clears parenterally ingested iron from the plasma determines its bioavailability. If the reticuloendothelial system clears iron effectively, only small amounts will become available over time to the bone marrow.
Transferrin accepts iron from the intestinal tract and also from sites of hemoglobin storage and destruction .
[L2190]
[L2182]
Feraheme showed dose-dependent, capacity-limited elimination from the plasma with a half-life of approximately 15 hours in humans .
[L2182]
[L2182]
[L2186]
Iron, bound to transferrin, is then transported in the plasma and distributed to the bone marrow for the synthesis of hemoglobin, to the reticuloendothelial system for storage, and to all cells for enzymes containing iron, and to placental cells if needed to meet fetal needs. Transferrin eventually becomes available for recycling. In normal adults, 90% of metabolized iron is conserved and reutilized repeatedly .
[L2190]
[L2185]
[L2184]
One study estimated the clearance to be 0.0221 L/h .
[L2179]
Proteins that carry this drug through the body
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Ferumoxytol
Additional database identifiers
Drugs Product Database (DPD)
309
ChemSpider
4937312
HUGO Gene Nomenclature Committee (HGNC)
HGNC:11740
GenAtlas
TF
GeneCards
TF
GenBank Gene Database
M12530
GenBank Protein Database
339453
UniProt Accession
TRFE_HUMAN
Patent information
All patents expired, 6 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
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