Ferric carboxymaltose

Identification

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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
  • Ferric Carboxymaltose
  • Iron Carboxymaltose
  • Iron Dextri-Maltose
External IDs
VIT 45
Active Moieties
NameKindUNIICASInChI Key
Ferric cationionic91O4LML61120074-52-6VTLYFUHAOXGGBS-UHFFFAOYSA-N
Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing End
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

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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.

Associated Conditions
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.

Additional Data Available
Adverse Effects

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Additional Data Available
Contraindications

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Blackbox Warnings

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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
DrugInteraction
3-Aza-2,3-Dihydrogeranyl DiphosphateFerric carboxymaltose 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 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.
DifloxacinFerric carboxymaltose can cause a decrease in the absorption of Difloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
DimercaprolDimercaprol may increase the nephrotoxic activities of Ferric carboxymaltose.
Additional Data Available
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  • Severity
    Severity

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  • Evidence Level
    Evidence Level

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  • Action
    Evidence Level

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Food Interactions
Not Available

References

General References
Not Available
External Links
KEGG Drug
D08920
PubChem Substance
347910386
ChEMBL
CHEMBL2108597
Wikipedia
Iron_supplement
FDA label
Download (269 KB)

Clinical Trials

Clinical Trials
PhaseStatusPurposeConditionsCount
1CompletedTreatmentChronic Heart Failure (CHF)1
1RecruitingOtherIron Deficiency Anemia (IDA)1
1WithdrawnTreatmentFunctional Iron Deficiency / ICU Anemia1
2Active Not RecruitingSupportive CareMetastatic Colorectal Cancers1
2CompletedSupportive CareGastrointestinal Stromal Tumor With Neurogenic Differentiation / Malignant Neoplasms of Mesothelial and Soft Tissue1
2CompletedTreatmentFibromyalgia / Iron Deficiency1
2CompletedTreatmentHeart Failure, Systolic / Iron Deficiency1
2CompletedTreatmentIron Deficiency Anemia (IDA)3
2CompletedTreatmentRestless Legs Syndrome (RLS)2
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
2, 3TerminatedTreatmentIron-Deficiency Anemias / Postpartum Depression / Puerperal Disorders1
3Active Not RecruitingTreatmentAnemias1
3Active Not RecruitingTreatmentCancer and Chemotherapy Related Anemia1
3Active Not RecruitingTreatmentIron Deficiency / Type 2 Diabetes Mellitus1
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
3CompletedTreatmentIDA - Iron Deficiency Anemia2
3CompletedTreatmentImpaired Renal Function / Iron Deficiency Anemia (IDA)1
3CompletedTreatmentIron Deficiency1
3CompletedTreatmentIron Deficiency Anemia (IDA)3
3CompletedTreatmentIron-Deficiency Anemias1
3CompletedTreatmentPostpartum Anemia1
3Not Yet RecruitingTreatmentCardiac Failure / Heart Failure With Reduced Ejection Fraction (HFrEF) / Heart Failure, Systolic1
3Not Yet RecruitingTreatmentIron-Deficiency / Transplant-Related Disorder1
3RecruitingTreatmentFerropenic Anemia / Heart Failure With Normal Ejection Fraction1
3RecruitingTreatmentHeart Failure / Iron-Deficiency1
3RecruitingTreatmentIron Deficiency Anemia (IDA)2
3TerminatedTreatmentAnemias / Chronic Heart Failure (CHF) / Iron Deficiency / Iron Deficiency Anemia (IDA)1
3TerminatedTreatmentAnemias / Heart Failure / Iron Deficiency1
4Active Not RecruitingTreatmentAnemia of Chronic Kidney Disease1
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 Anemias1
4CompletedTreatmentAnemias / Heart Failure / 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
4CompletedTreatmentOsteoarthritis (OA)1
4CompletedTreatmentTiredness1
4Not Yet RecruitingBasic ScienceIron-Deficiency / Tiredness1
4Not Yet RecruitingTreatmentAnemias1
4Not Yet RecruitingTreatmentBlood Loss Anemia1
4Not Yet RecruitingTreatmentKnee Osteoarthritis (Knee OA) / Postoperative Anaemia / Total Knee Arthroplasty (TKA)2
4RecruitingOtherGlucose Metabolism Disorders (Including Diabetes Mellitus) / Iron Toxicity / Iron-Deficiency / Metabolic Disorder, Glucose / Metabolic Side Effects of Drugs / Safety Issues1
4RecruitingPreventionCoronary Artery Disease / Postoperative Complications1
4RecruitingPreventionIron Deficiency Anemia (IDA)1
4RecruitingTreatmentAnemias1
4RecruitingTreatmentAnemias / Major Abdominal Surgery / Pre-operative1
4RecruitingTreatmentCystic Fibrosis (CF) / Iron-Deficiency1
4RecruitingTreatmentEndothelial Dysfunction / Iron Toxicity / Oxidative Stress / Renal Anemia1
4RecruitingTreatmentHeart Failure1
4RecruitingTreatmentHeart Failure / Iron Deficiency1
4RecruitingTreatmentInflammatory Bowel Diseases (IBD)1
4TerminatedTreatmentHeart Failure1
4TerminatedTreatmentIron-Deficiency Anemias1
4Unknown StatusTreatmentPostoperative Anaemia1
4WithdrawnTreatmentHeart Failure1
Not AvailableCompletedBasic ScienceIron Deficiency1
Not AvailableNot Yet RecruitingTreatmentPrognathic Surgery1

Pharmacoeconomics

Manufacturers
Not Available
Packagers
Not Available
Dosage forms
FormRouteStrength
Injection, solutionIntravenous50 mg/1mL
Prices
Not Available
Patents
Patent NumberPediatric ExtensionApprovedExpires (estimated)
US8895612No2014-11-252027-01-08Us
US7754702No2010-07-132027-02-13Us
US7612109No2009-11-032024-02-05Us
US9376505No2016-06-282023-10-20Us
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

Taxonomy

Classification
Not classified

Drug created on July 31, 2013 23:33 / Updated on May 01, 2019 10:47