Ferric carboxymaltose

Identification

Name
Ferric carboxymaltose
Accession Number
DB08917
Description

Ferric Carboxymaltose is an iron replacement product and chemically, an iron carbohydrate complex. FDA approved on July 25, 2013.

Type
Small Molecule
Groups
Approved
Synonyms
  • Ferric carboxymaltose
  • Iron carboxymaltose
  • Iron dextri-maltose
External IDs
  • VIT 45

Pharmacology

Indication

Ferric carboxymaltose is a iron replacement product indicated for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or those who have non-dialysis dependent chronic kidney disease.

Associated Conditions
Contraindications & Blackbox Warnings
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Pharmacodynamics

When measured using positron emission tomography (PET), the red cell uptake of 59-Fe and 52-Fe from INJECTAFER ranged from 61% to 99%. In patients with iron deficiency, the red cell uptake ranged from 91% to 99%. In patients with renal anemia, the red cell uptake ranged from 61% to 84%.

Mechanism of action

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that release iron.

Absorption

When a single dose of 100 to 1000 mg of iron was given to iron deficient patients, the maximum serum concentration (Cmax) was 37 μg/mL to 333 μg/mL. These levels were obtained 15 minutes to 1.21 hours post dose (Tmax).

Volume of distribution

3 L

Protein binding
Not Available
Metabolism
Not Available
Route of elimination

Renal elimination of iron was negligible.

Half-life

7 to 12 hours.

Clearance
Not Available
Adverse Effects
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Toxicity

The most common adverse reactions (>2%) are nausea, hypertension, flushing, hypophosphatemia, and dizziness.

Affected organisms
  • Humans and other mammals
Pathways
Not Available
Pharmacogenomic Effects/ADRs
Not Available

Interactions

Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
DrugInteraction
Calcium PhosphateFerric carboxymaltose can cause a decrease in the absorption of Calcium Phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Calcium phosphate dihydrateFerric carboxymaltose can cause a decrease in the absorption of Calcium phosphate dihydrate resulting in a reduced serum concentration and potentially a decrease in efficacy.
CarbidopaFerric carboxymaltose can cause a decrease in the absorption of Carbidopa resulting in a reduced serum concentration and potentially a decrease in efficacy.
CinoxacinFerric carboxymaltose can cause a decrease in the absorption of Cinoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
CiprofloxacinFerric carboxymaltose can cause a decrease in the absorption of Ciprofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
DeferiproneThe serum concentration of Deferiprone can be decreased when it is combined with Ferric carboxymaltose.
DelafloxacinFerric carboxymaltose can cause a decrease in the absorption of Delafloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
DimercaprolDimercaprol may increase the nephrotoxic activities of Ferric carboxymaltose.
Dipotassium phosphateFerric carboxymaltose can cause a decrease in the absorption of Dipotassium phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.
EnoxacinFerric carboxymaltose can cause a decrease in the absorption of Enoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Additional Data Available
  • Extended Description
    Extended Description

    Extended description of the mechanism of action and particular properties of each drug interaction.

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  • Severity
    Severity

    A severity rating for each drug interaction, from minor to major.

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  • Evidence Level
    Evidence Level

    A rating for the strength of the evidence supporting each drug interaction.

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  • Action
    Action

    An effect category for each drug interaction. Know how this interaction affects the subject drug.

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Food Interactions
No interactions found.

Products

Active Moieties
NameKindUNIICASInChI Key
Ferric cationionic91O4LML61120074-52-6VTLYFUHAOXGGBS-UHFFFAOYSA-N
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
InjectaferInjection, solution50 mg/1mLIntravenousAMERICAN REGENT, INC.2013-08-12Not applicableUs
Additional Data Available
  • Application Number
    Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code
    Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Categories

Drug Categories
Classification
Not classified

Chemical Identifiers

UNII
6897GXD6OE
CAS number
9007-72-1
InChI Key
Not Available
InChI
Not Available
IUPAC Name
Not Available
SMILES
Not Available

References

General References
Not Available
KEGG Drug
D08920
PubChem Substance
347910386
RxNav
1433693
ChEMBL
CHEMBL2108597
Drugs.com
Drugs.com Drug Page
Wikipedia
Iron_supplement
FDA label
Download (269 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
4Active Not RecruitingTreatmentAnemia of Chronic Kidney Disease1
4Active Not RecruitingTreatmentEndothelial Dysfunction / Iron Toxicity / Oxidative Stress / Renal Anemia1
4Active Not RecruitingTreatmentIron Deficiency Anemia (IDA)1
4Active Not RecruitingTreatmentIron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass1
4Active Not RecruitingTreatmentIron Deficiency Anemia (IDA) / Iron-Deficiency Anemias1
4CompletedTreatmentAnemia / Heart Failure / Iron Deficiency1
4CompletedTreatmentAnemia / Iron Deficiency2
4CompletedTreatmentAnemia / Neoplasms, Colorectal2
4CompletedTreatmentChronic Heart Failure (CHF) / Iron Deficiency1
4CompletedTreatmentFatigue1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
SolutionIntravenous500 mg
Injection, solutionIntravenous50 mg/1mL
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US8895612No2014-11-252027-01-08Us
US7754702No2010-07-132027-02-13Us
US7612109No2009-11-032024-02-05Us
US9376505No2016-06-282023-10-20Us
US10519252No2019-12-312023-10-20Us
Additional Data Available
  • Filed On
    Filed On

    The date on which a patent was filed with the relevant government.

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Properties

State
Solid
Experimental Properties
Not Available
Predicted Properties
Not Available
Predicted ADMET Features
Not Available

Spectra

Mass Spec (NIST)
Not Available
Spectra
Not Available

Drug created on July 31, 2013 23:33 / Updated on June 12, 2020 11:42

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