Ferric carboxymaltose

Identification

Summary

Ferric carboxymaltose is an iron replacement therapy used to treat iron deficiency anemia in children and adults with intolerance or inadequate clinical response to oral iron, and in adult patients who have non-dialysis dependent chronic kidney disease.

Brand Names
Injectafer
Generic Name
Ferric carboxymaltose
DrugBank Accession Number
DB08917
Background

Ferric carboxymaltose is an iron replacement product and, chemically, an iron-carbohydrate complex. It was 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 an iron replacement product indicated for the treatment of iron deficiency anemia in patients ≥1 year of age who have an intolerance to, or unsatisfactory response from, oral iron therapy,2 and in adult patients who have non-dialysis-dependent chronic kidney disease.2 It is also indicated to treat iron deficiency and improve exercise capacity in adult patients with NYHA class II or III heart failure.2

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Treatment ofIron deficiency (id)•••••••••••••••••••••••• ••••• ••••••• •••• ••••••• •••••••• •••••••• ••••• ••••• ••••••••••••
Treatment ofIron deficiency anemia••••••••••••••••••••••••••
Treatment ofIron deficiency anemia•••••••••••••••••• •••••••••••••••••••• •• •••• •••• •••••••••••••••••••••
Treatment ofIron deficiency anemia•••••••••••••••••• ••••••••••••••••••••• •••••••• •• •••• •••••••••••••
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%.2 In patients with iron deficiency, the red cell uptake ranged from 91% to 99%.2 In patients with renal anemia, the red cell uptake ranged from 61% to 84%.2

Mechanism of action

Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron.2

Absorption

When a single dose of 100 to 1000 mg of iron was given to iron-deficient patients, the maximum serum concentration was 37 μg/mL to 333 μg/mL. These levels were obtained 15 minutes to 1.21 hours post-dose.2

Volume of distribution

The estimated volume of distribution after a single dose was 3 liters.2

Protein binding

Not Available

Metabolism
Not Available
Route of elimination

Renal elimination of iron was negligible.2

Half-life

The terminal half-life of ferric carboxymaltose ranges from 7-12 hours.2 The elimination half-life in pediatric patients was approximately 9.7 hours.2

Clearance

Not Available

Adverse Effects
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Toxicity

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

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.
Food Interactions
No interactions found.

Products

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Active Moieties
NameKindUNIICASInChI Key
Ferric cationionic91O4LML61120074-52-6VTLYFUHAOXGGBS-UHFFFAOYSA-N
Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
InjectaferInjection, solution50 mg/1mLIntravenousAMERICAN REGENT, INC.2021-06-01Not applicableUS flag
InjectaferInjection, solution50 mg/1mLIntravenousAMERICAN REGENT, INC.2013-08-12Not applicableUS flag
InjectaferInjection, solution50 mg/1mLIntravenousAMERICAN REGENT, INC.2022-06-01Not applicableUS flag

Categories

Drug Categories
Classification
Not classified
Affected organisms
  • Humans and other mammals

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
  1. FDA Approved Drug Products: Injectafer (ferric carboxymaltose) for intravenous injection [Link]
  2. FDA Approved Drug Products: Injectafer (ferric carboxymaltose) for intravenous injection (May 2023) [Link]
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 Pregnancy / Iron Deficiency Anemia (IDA) / Low Birth Weight Infants1
4Active Not RecruitingTreatmentEndothelial Dysfunction / Iron Toxicity / Renal Anemia / Stress Oxidative1
4CompletedPreventionIron Deficiency Anemia (IDA)1
4CompletedTreatmentAnemia of Chronic Kidney Disease1
4CompletedTreatmentAnemia / Colorectal Neoplasms2

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage Forms
FormRouteStrength
InjectionIntravenous
Injection, solutionIntravenous50 mg/mL
Injection, solution; injection, solution, concentrateIntravenous
Injection, solution; injection, solution, concentrateIntravenous50 mg
Injection, solutionIntravenous bolus; Intravenous drip50 mg/ml
SolutionIntravenous500 mg
SolutionIntravenous50000000 mg
SolutionIntravenous50 mg
Injection, solutionIntravenous50 mg/1mL
SolutionParenteral360. mg
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)Region
US8895612No2014-11-252027-01-08US flag
US7754702No2010-07-132027-02-13US flag
US7612109No2009-11-032024-02-05US flag
US9376505No2016-06-282023-10-20US flag
US10519252No2019-12-312023-10-20US flag
US11123321No2021-09-212023-10-20US flag
US11291645No2003-10-202023-10-20US flag
US11433091No2007-01-082027-01-08US flag
US11478502No2007-01-082027-01-08US flag
US11590097No2003-10-202023-10-20US flag
US11364260No2007-01-082027-01-08US flag

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
Chromatographic Properties
Collision Cross Sections (CCS)
Not Available

Drug created at August 01, 2013 05:33 / Updated at January 03, 2024 23:22