Ferric Carboxymaltose

Identification

Name
Ferric Carboxymaltose
Accession Number
DB08917
Type
Small Molecule
Groups
Approved
Description

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

Synonyms
  • Iron Carboxymaltose
  • Iron Dextri-Maltose
  • VIT 45
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
InjectaferInjection, solution50 mg/mLIntravenousAmerican Regent2013-08-12Not applicableUs
Categories
UNII
6897GXD6OE
CAS number
9007-72-1
Weight
Not Available
Chemical Formula
Not Available
InChI Key
Not Available
InChI
Not Available
IUPAC Name
Not Available
SMILES
Not Available

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.

Structured Indications
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
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
DrugInteractionDrug group
AlmasilateAlmasilate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Experimental
AloglutamolAloglutamol can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
AluminiumAluminium can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Aluminium acetoacetateAluminium acetoacetate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
Aluminium glycinateAluminium glycinate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
Aluminum hydroxideAluminum hydroxide can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
AsenapineAsenapine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Bismuth SubcitrateBismuth Subcitrate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Bismuth subnitrateBismuth subnitrate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
Calcium CarbonateCalcium Carbonate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Calcium silicateCalcium silicate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
CefdinirThe serum concentration of Cefdinir can be decreased when it is combined with Ferric Carboxymaltose.Approved
ChlortetracyclineChlortetracycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational, Vet Approved
CimetidineCimetidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
CinoxacinThe serum concentration of Cinoxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational, Withdrawn
DeferiproneThe serum concentration of Deferiprone can be decreased when it is combined with Ferric Carboxymaltose.Approved
DemeclocyclineDemeclocycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
DexlansoprazoleDexlansoprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
DexrabeprazoleDexrabeprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
DimercaprolDimercaprol may increase the nephrotoxic activities of Ferric Carboxymaltose.Approved
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.Approved
DolutegravirThe serum concentration of Dolutegravir can be decreased when it is combined with Ferric Carboxymaltose.Approved
DoxepinDoxepin can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
DoxycyclineDoxycycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational, Vet Approved
EltrombopagThe serum concentration of Eltrombopag can be decreased when it is combined with Ferric Carboxymaltose.Approved
EnoxacinThe serum concentration of Enoxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational
EpinastineEpinastine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
EsomeprazoleEsomeprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
FamotidineFamotidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
FleroxacinThe serum concentration of Fleroxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved
FlumequineThe serum concentration of Flumequine can be decreased when it is combined with Ferric Carboxymaltose.Withdrawn
GarenoxacinThe serum concentration of Garenoxacin can be decreased when it is combined with Ferric Carboxymaltose.Investigational
GatifloxacinThe serum concentration of Gatifloxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational
GemifloxacinThe serum concentration of Gemifloxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational
GrepafloxacinThe serum concentration of Grepafloxacin can be decreased when it is combined with Ferric Carboxymaltose.Investigational, Withdrawn
HydrotalciteHydrotalcite can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental, Investigational
LansoprazoleLansoprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
LevodopaThe serum concentration of Levodopa can be decreased when it is combined with Ferric Carboxymaltose.Approved
LevofloxacinThe serum concentration of Levofloxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational
LevothyroxineThe serum concentration of Levothyroxine can be decreased when it is combined with Ferric Carboxymaltose.Approved
Lipoic AcidFerric Carboxymaltose can cause a decrease in the absorption of Lipoic Acid resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Nutraceutical
MagaldrateMagaldrate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Withdrawn
Magnesium HydroxideMagnesium Hydroxide can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Magnesium oxideMagnesium oxide can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Magnesium peroxideMagnesium peroxide can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
Magnesium silicateMagnesium silicate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Experimental
Magnesium TrisilicateMagnesium Trisilicate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
MethanthelineMethantheline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
MethyldopaThe serum concentration of Methyldopa can be decreased when it is combined with Ferric Carboxymaltose.Approved
MetiamideMetiamide can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Experimental
MinocyclineMinocycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
Nalidixic AcidThe serum concentration of Nalidixic Acid can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational
NemonoxacinThe serum concentration of Nemonoxacin can be decreased when it is combined with Ferric Carboxymaltose.Investigational
NizatidineNizatidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
NorfloxacinThe serum concentration of Norfloxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved
OlanzapineOlanzapine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
OmeprazoleOmeprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational, Vet Approved
Oxolinic acidThe serum concentration of Oxolinic acid can be decreased when it is combined with Ferric Carboxymaltose.Experimental
PancrelipasePancrelipase can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
PantoprazolePantoprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
PazufloxacinThe serum concentration of Pazufloxacin can be decreased when it is combined with Ferric Carboxymaltose.Investigational
PefloxacinThe serum concentration of Pefloxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved
PenicillamineFerric Carboxymaltose can cause a decrease in the absorption of Penicillamine resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Pipemidic acidThe serum concentration of Pipemidic acid can be decreased when it is combined with Ferric Carboxymaltose.Experimental
Piromidic acidThe serum concentration of Piromidic acid can be decreased when it is combined with Ferric Carboxymaltose.Experimental
PromethazinePromethazine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
PrulifloxacinThe serum concentration of Prulifloxacin can be decreased when it is combined with Ferric Carboxymaltose.Investigational
RabeprazoleRabeprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
RanitidineRanitidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
RosoxacinThe serum concentration of Rosoxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational
Roxatidine acetateRoxatidine acetate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved, Investigational
RufloxacinThe serum concentration of Rufloxacin can be decreased when it is combined with Ferric Carboxymaltose.Experimental
SitafloxacinThe serum concentration of Sitafloxacin can be decreased when it is combined with Ferric Carboxymaltose.Experimental, Investigational
Sodium bicarbonateSodium bicarbonate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Sodium glycerophosphateFerric Carboxymaltose can cause a decrease in the absorption of Sodium glycerophosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
Sodium phosphateFerric Carboxymaltose can cause a decrease in the absorption of Sodium phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
SparfloxacinThe serum concentration of Sparfloxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational
Technetium Tc-99m oxidronateFerric Carboxymaltose can cause a decrease in the absorption of Technetium Tc-99m oxidronate resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
TemafloxacinThe serum concentration of Temafloxacin can be decreased when it is combined with Ferric Carboxymaltose.Withdrawn
TriethylenetetramineThe serum concentration of Ferric Carboxymaltose can be decreased when it is combined with Triethylenetetramine.Approved
TromethamineTromethamine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.Approved
TrovafloxacinThe serum concentration of Trovafloxacin can be decreased when it is combined with Ferric Carboxymaltose.Approved, Investigational, Withdrawn
Food Interactions
Not Available

References

General References
Not Available
External Links
KEGG Drug
D08920
PubChem Substance
347910386
ChEMBL
CHEMBL2108597
Drugs.com
Drugs.com Drug Page
FDA label
Download (269 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentChronic Heart Failure (CHF)1
1SuspendedTreatmentFunctional Iron Deficiency / ICU Anemia1
2CompletedTreatmentFibromyalgia / Iron Deficiency1
2CompletedTreatmentHeart Failure, Systolic / Iron Deficiency1
2CompletedTreatmentIron Deficiency Anemia (IDA)1
2CompletedTreatmentRestless Legs Syndrome (RLS)2
2RecruitingSupportive CareGastrointestinal Stromal Tumor With Neurogenic Differentiation / Malignant Neoplasms of Mesothelial and Soft Tissue1
2RecruitingSupportive CareMetastatic Colorectal Cancers1
2RecruitingTreatmentAnemias / Malignant Neoplasm of Pancreas1
2RecruitingTreatmentChronic Fatigue / Inflammatory Bowel Diseases (IBD)1
2RecruitingTreatmentChronic Obstructive Pulmonary Disease (COPD)1
2RecruitingTreatmentIron-Deficiency1
2RecruitingTreatmentRestless Legs Syndrome (RLS)1
2TerminatedTreatmentIron-Deficiency Anemias / Thrombocytosis1
2Unknown StatusTreatmentIron Deficiency Anemia (IDA)2
2, 3TerminatedTreatmentIron-Deficiency Anemias / Postpartum Depression / Puerperal Disorders1
3Active Not RecruitingTreatmentCancer and Chemotherapy Related Anemia1
3Active Not RecruitingTreatmentIron-Deficiency Anemias1
3Active Not RecruitingTreatmentRestless Legs Syndrome (RLS)1
3CompletedTreatmentAnemias10
3CompletedTreatmentAnemias / Chronic Heart Failure (CHF) / Iron Deficiency / Iron Deficiency Anemia (IDA)1
3CompletedTreatmentAnemias / Crohn's Disease (CD) / Inflammatory Bowel Diseases (IBD) / Iron Deficiency / Iron-Deficiency Anemias / Ulcerative Colitis (UC)1
3CompletedTreatmentChronic Heart Failure (CHF) / Iron Deficiency1
3CompletedTreatmentChronic Kidney Disease (CKD) / Iron Deficiency Anemia (IDA)1
3CompletedTreatmentHER2 Positive Breast Cancers / Inflammatory carcinoma of the breast / Invasive Ductal Breast Carcinoma / Malignant Neoplasm of Female Breast / Mucinous Breast Cancer Stage II / Tubular Breast Cancer Stage II / Tubular Breast Cancer Stage III1
3CompletedTreatmentHip Fractures1
3CompletedTreatmentImpaired Renal Function / Iron Deficiency Anemia (IDA)1
3CompletedTreatmentIron Deficiency1
3CompletedTreatmentIron Deficiency Anemia (IDA)2
3CompletedTreatmentIron-Deficiency Anemias1
3CompletedTreatmentPostpartum Anemia1
3RecruitingTreatmentAnemias1
3RecruitingTreatmentHeart Failure, Unspecified / Iron-Deficiency1
3RecruitingTreatmentIDA - Iron Deficiency Anemia2
3RecruitingTreatmentIron Deficiency / Type 2 Diabetes Mellitus1
3TerminatedTreatmentAnemias / Chronic Heart Failure (CHF) / Iron Deficiency / Iron Deficiency Anemia (IDA)1
3TerminatedTreatmentAnemias / Heart Failure, Unspecified / Iron Deficiency1
4Active Not RecruitingTreatmentIron Deficiency Anemia (IDA)1
4Active Not RecruitingTreatmentIron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass1
4CompletedTreatmentAnemias / Heart Failure, Unspecified / Iron Deficiency1
4CompletedTreatmentAnemias / Iron Deficiency1
4CompletedTreatmentAnemias / Neoplasms, Colorectal2
4CompletedTreatmentChronic Heart Failure (CHF) / Iron Deficiency1
4CompletedTreatmentIron Deficiency Anemia (IDA) / Restless Legs Syndrome (RLS)1
4CompletedTreatmentKnee Osteoarthritis (Knee OA) / Postoperative Anaemia1
4CompletedTreatmentTiredness1
4Not Yet RecruitingBasic ScienceIron-Deficiency / Tiredness1
4Not Yet RecruitingTreatmentAnemias1
4Not Yet RecruitingTreatmentHeart Failure, Unspecified1
4Not Yet RecruitingTreatmentOsteoarthritis (OA)1
4RecruitingOtherGlucose Metabolism Disorders (Including Diabetes Mellitus) / Iron Toxicity / Iron-Deficiency / Metabolic Disorder, Glucose / Metabolic Side Effects of Drugs / Safety Issues1
4RecruitingTreatmentAnemia of Chronic Kidney Disease1
4RecruitingTreatmentAnemias1
4RecruitingTreatmentAnemias / Major Abdominal Surgery / Pre-operative1
4RecruitingTreatmentEndothelial Dysfunction / Iron Toxicity / Oxidative Stress / Renal Anemia1
4RecruitingTreatmentHeart Failure, Unspecified2
4RecruitingTreatmentHeart Failure, Unspecified / Iron Deficiency1
4RecruitingTreatmentIron-Deficiency Anemias1
4TerminatedTreatmentIron-Deficiency Anemias1
4Unknown StatusTreatmentPostoperative Anaemia1
Not AvailableCompletedBasic ScienceIron Deficiency1
Not AvailableNot Yet RecruitingTreatmentPrognathic Surgery1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, solutionIntravenous50 mg/mL
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US8895612No2007-01-082027-01-08Us
US7754702No2007-02-132027-02-13Us
US7612109No2004-02-052024-02-05Us
US9376505No2003-10-202023-10-20Us

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

Taxonomy

Classification
Not classified

Drug created on July 31, 2013 23:33 / Updated on November 06, 2017 06:46