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

Name	Kind	UNII	CAS	InChI Key
Ferric cation	ionic	91O4LML611	20074-52-6	VTLYFUHAOXGGBS-UHFFFAOYSA-N

Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
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Injectafer	Injection, solution	50 mg/1mL	Intravenous	AMERICAN REGENT, INC.	2013-08-12	Not applicable

Additional Data Available

Application Number
Application Number
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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

• Biopolymers
• Carbohydrates
• Compounds used in a research, industrial, or household setting
• Disaccharides
• Glucans
• Iron Compounds
• Macromolecular Substances
• Oligosaccharides
• Organometallic Compounds
• Parenteral Iron Replacement
• Phosphate Binder
• Polymers
• Polysaccharides

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

• Iron Deficiency Anemia (IDA)

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.

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Adverse Effects

Comprehensive structured data on known drug adverse effects with statistical prevalence. MedDRA and ICD10 ids are provided for adverse effect conditions and symptoms.

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Contraindications

Structured data covering drug contraindications. Each contraindication describes a scenario in which the drug is not to be used. Includes restrictions on co-administration, contraindicated populations, and more.

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Additional Data Available

Blackbox Warnings

Structured data representing warnings from the black box section of drug labels. These warnings cover important and dangerous risks, contraindications, or adverse effects.

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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

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.

• All Drugs
• Approved
• Vet approved
• Nutraceutical
• Illicit
• Withdrawn
• Investigational
• Experimental

Drug	Interaction
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3-Aza-2,3-Dihydrogeranyl Diphosphate	Ferric 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 Phosphate	Ferric 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 dihydrate	Ferric carboxymaltose can cause a decrease in the absorption of Calcium phosphate dihydrate resulting in a reduced serum concentration and potentially a decrease in efficacy.
Carbidopa	Ferric carboxymaltose can cause a decrease in the absorption of Carbidopa resulting in a reduced serum concentration and potentially a decrease in efficacy.
Cinoxacin	Ferric carboxymaltose can cause a decrease in the absorption of Cinoxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Ciprofloxacin	Ferric carboxymaltose can cause a decrease in the absorption of Ciprofloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Deferiprone	The serum concentration of Deferiprone can be decreased when it is combined with Ferric carboxymaltose.
Delafloxacin	Ferric carboxymaltose can cause a decrease in the absorption of Delafloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Difloxacin	Ferric carboxymaltose can cause a decrease in the absorption of Difloxacin resulting in a reduced serum concentration and potentially a decrease in efficacy.
Dimercaprol	Dimercaprol may increase the nephrotoxic activities of Ferric carboxymaltose.

Additional Data Available

Extended Description
Extended Description
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Severity
Severity
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Evidence Level
Evidence Level
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Action
Action
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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

Wikipedia

Iron_supplement

FDA label

Download (269 KB)

Clinical Trials

Clinical Trials

Phase	Status	Purpose	Conditions	Count
1	Completed	Other	Iron Deficiency Anemia (IDA)	1
1	Completed	Treatment	Chronic Heart Failure (CHF)	1
1	Withdrawn	Treatment	Functional Iron Deficiency / ICU Anemia	1
2	Active Not Recruiting	Supportive Care	Metastatic Colorectal Cancer (MCRC)	1
2	Completed	Supportive Care	Gastrointestinal Stromal Tumor With Neurogenic Differentiation / Malignant Neoplasms of Mesothelial and Soft Tissue	1
2	Completed	Treatment	Fibromyalgia / Iron Deficiency	1
2	Completed	Treatment	Heart Failure, Systolic / Iron Deficiency	1
2	Completed	Treatment	Iron Deficiency Anemia (IDA)	3
2	Completed	Treatment	Restless Legs Syndrome (RLS)	2
2	Recruiting	Treatment	Anemias / Malignant Neoplasm of Pancreas	1
2	Recruiting	Treatment	Chronic Fatigue / Inflammatory Bowel Diseases (IBD)	1
2	Recruiting	Treatment	Chronic Obstructive Pulmonary Disease (COPD)	1
2	Recruiting	Treatment	Heart Failure / Iron-Deficiency	1
2	Recruiting	Treatment	Iron-Deficiency	1
2	Recruiting	Treatment	Restless Legs Syndrome (RLS)	1
2	Terminated	Treatment	Iron-Deficiency Anemias / Thrombocytosis	1
2, 3	Terminated	Treatment	Iron-Deficiency Anemias / Postpartum Depression / Puerperal Disorders	1
3	Active Not Recruiting	Treatment	Cancer and Chemotherapy Related Anemia	1
3	Active Not Recruiting	Treatment	Iron Deficiency / Type 2 Diabetes Mellitus	1
3	Active Not Recruiting	Treatment	Iron-Deficiency Anemias	1
3	Active Not Recruiting	Treatment	Restless Legs Syndrome (RLS)	1
3	Completed	Treatment	Anemias	13
3	Completed	Treatment	Anemias / Chronic Heart Failure (CHF) / Iron Deficiency / Iron Deficiency Anemia (IDA)	1
3	Completed	Treatment	Anemias / Crohn's Disease (CD) / Inflammatory Bowel Diseases (IBD) / Iron Deficiency / Iron-Deficiency Anemias / Ulcerative Colitis	1
3	Completed	Treatment	Chronic Heart Failure (CHF) / Iron Deficiency	1
3	Completed	Treatment	Chronic Kidney Disease (CKD) / Iron Deficiency Anemia (IDA)	1
3	Completed	Treatment	HER2 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 III	1
3	Completed	Treatment	Hip Fracture	1
3	Completed	Treatment	IDA - Iron Deficiency Anemia	2
3	Completed	Treatment	Iron Deficiency	1
3	Completed	Treatment	Iron Deficiency Anemia (IDA)	3
3	Completed	Treatment	Impaired kidney function / Iron Deficiency Anemia (IDA)	1
3	Completed	Treatment	Iron-Deficiency Anemias	1
3	Completed	Treatment	Postpartum Anemia	1
3	Not Yet Recruiting	Treatment	Iron-Deficiency / Postpartum Anemia Nos	1
3	Recruiting	Treatment	Acute Myocardial Infarction (AMI) / Atrial Fibrillation (AF) / Cardiovascular Heart Disease / Heart Failure With Reduced Ejection Fraction (HFrEF) / Iron-Deficiency Anemias	1
3	Recruiting	Treatment	Ferropenic Anemia / Heart Failure With Normal Ejection Fraction	1
3	Recruiting	Treatment	Heart Failure / Iron-Deficiency	1
3	Recruiting	Treatment	Iron Deficiency Anemia (IDA)	3
3	Recruiting	Treatment	Iron-Deficiency / Transplant-Related Disorder	1
3	Terminated	Treatment	Anemias / Chronic Heart Failure (CHF) / Iron Deficiency / Iron Deficiency Anemia (IDA)	1
3	Terminated	Treatment	Anemias / Heart Failure / Iron Deficiency	1
4	Active Not Recruiting	Treatment	Anemia of Chronic Kidney Disease	1
4	Active Not Recruiting	Treatment	Endothelial Dysfunction / Iron Toxicity / Oxidative Stress / Renal Anemia	1
4	Active Not Recruiting	Treatment	Iron Deficiency Anemia (IDA)	1
4	Active Not Recruiting	Treatment	Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass	1
4	Active Not Recruiting	Treatment	Iron-Deficiency Anemias	1
4	Completed	Treatment	Anemias / Heart Failure / Iron Deficiency	1
4	Completed	Treatment	Anemias / Iron Deficiency	2
4	Completed	Treatment	Anemias / Neoplasms, Colorectal	2
4	Completed	Treatment	Chronic Heart Failure (CHF) / Iron Deficiency	1
4	Completed	Treatment	Fatigue	1
4	Completed	Treatment	Heart Failure / Iron-Deficiency	1
4	Completed	Treatment	Iron Deficiency Anemia (IDA) / Restless Legs Syndrome (RLS)	1
4	Completed	Treatment	Knee Osteoarthritis (Knee OA) / Postoperative Anaemia	1
4	Completed	Treatment	Osteoarthritis (OA)	1
4	Not Yet Recruiting	Basic Science	Fatigue / Iron-Deficiency	1
4	Not Yet Recruiting	Prevention	Anemias / General Surgery / Iron Deficiency Anemia (IDA) / Malignant Neoplasm of Stomach / Surgery--Complications	1
4	Not Yet Recruiting	Treatment	Anemias	1
4	Not Yet Recruiting	Treatment	Cardiac Failure / Heart Failure With Reduced Ejection Fraction (HFrEF) / Heart Failure, Systolic	1
4	Not Yet Recruiting	Treatment	Knee Osteoarthritis (Knee OA) / Postoperative Anaemia / Total Knee Arthroplasty (TKA)	2
4	Not Yet Recruiting	Treatment	Osteoarthritis, Hip	1
4	Recruiting	Other	Glucose Metabolism Disorders (Including Diabetes Mellitus) / Iron Toxicity / Iron-Deficiency / Metabolic Disorder, Glucose / Metabolic Side Effects of Drugs / Safety Issues	1
4	Recruiting	Prevention	Aortic Aneurysm, Thoracic / Aortic Valve Stenosis / Coronary Artery Disease / Diseases of Mitral Valve / Postoperative Complications	1
4	Recruiting	Prevention	Iron Deficiency Anemia (IDA)	1
4	Recruiting	Treatment	Anemias	1
4	Recruiting	Treatment	Anemias / Major Abdominal Surgery / Pre-operative	1
4	Recruiting	Treatment	Anemias / Peripheral Obliterative Arteriopathy	1
4	Recruiting	Treatment	Blood Loss Anemia	1
4	Recruiting	Treatment	Chronic Obstructive Pulmonary Disease (COPD)	1
4	Recruiting	Treatment	Cystic Fibrosis (CF) / Iron-Deficiency	1
4	Recruiting	Treatment	Heart Failure	1
4	Recruiting	Treatment	Heart Failure / Iron Deficiency	1
4	Recruiting	Treatment	Inflammatory Bowel Diseases (IBD)	1
4	Terminated	Treatment	Heart Failure	1
4	Terminated	Treatment	Iron-Deficiency Anemias	1
4	Unknown Status	Treatment	Postoperative Anaemia	1
4	Withdrawn	Treatment	Heart Failure	1
Not Available	Completed	Basic Science	Altitude Hypoxia / Iron-Deficiency / Pulmonary vascular resistance abnormality / Ventricular Function	1
Not Available	Completed	Basic Science	Iron Deficiency	1
Not Available	Completed	Basic Science	Iron Deficiency / Lung Hypoxia / Pulmonary Arterial Hypertension (PAH)	1
Not Available	Completed	Other	Allogenic Transfusion / Hip Arthroplasty / Knee Replacement Surgery / Perioperative Anaemia	1
Not Available	Not Yet Recruiting	Treatment	Perioperative Anemia / Surgery, Cardiac / Transfusions	1
Not Available	Not Yet Recruiting	Treatment	Prognathic Surgery	1
Not Available	Recruiting	Treatment	Craniosynostosis	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage forms

Form	Route	Strength
Injection, solution	Intravenous	50 mg/1mL

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)
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US8895612	No	2014-11-25	2027-01-08
US7754702	No	2010-07-13	2027-02-13
US7612109	No	2009-11-03	2024-02-05
US9376505	No	2016-06-28	2023-10-20

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

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Drug created on July 31, 2013 23:33 / Updated on December 02, 2019 08:32