Ferric Carboxymaltose

ID Pharmacology Interactions References Trials Economics Properties Spectra Taxonomy

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.

Structure

Synonyms

Iron Carboxymaltose

Iron Dextri-Maltose

VIT 45

External IDs

Not Available

Product Ingredients

Not Available

Approved Prescription Products

Name	Dosage	Strength	Route	Labeller	Marketing Start	Marketing End
Injectafer	Injection, solution	50 mg/mL	Intravenous	American Regent	2013-08-12	Not applicable	US

Approved Generic Prescription Products

Not Available

Approved Over the Counter Products

Not Available

Unapproved/Other Products

Not Available

International Brands

Not Available

Brand mixtures

Not Available

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

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.

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

Drug	Interaction	Drug group
Aluminum hydroxide	Aluminum hydroxide can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Asenapine	Asenapine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Bismuth Subcitrate	Bismuth Subcitrate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Calcium Carbonate	Calcium carbonate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Cefdinir	The serum concentration of Cefdinir can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Chlortetracycline	Chlortetracycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Vet Approved
Cimetidine	Cimetidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Cinoxacin	The serum concentration of Cinoxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved, Withdrawn
Ciprofloxacin	The serum concentration of Ciprofloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved, Investigational
Deferiprone	The serum concentration of Deferiprone can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Demeclocycline	Demeclocycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Dexlansoprazole	TAK-390MR can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Dimercaprol	Dimercaprol may increase the nephrotoxic activities of Ferric Carboxymaltose.	Approved
Dipotassium phosphate	Ferric Carboxymaltose can cause a decrease in the absorption of Dipotassium phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Dolutegravir	The serum concentration of Dolutegravir can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Doxepin	Doxepin can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Doxycycline	Doxycycline 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
Eltrombopag	The serum concentration of Eltrombopag can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Enoxacin	The serum concentration of Enoxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Epinastine	Epinastine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Investigational
Esomeprazole	Esomeprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Investigational
Famotidine	Famotidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Fleroxacin	The serum concentration of Fleroxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Flumequine	The serum concentration of Flumequine can be decreased when it is combined with Ferric Carboxymaltose.	Withdrawn
Gatifloxacin	The serum concentration of Gatifloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved, Investigational
Gemifloxacin	The serum concentration of Gemifloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved, Investigational
Grepafloxacin	The serum concentration of Grepafloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Withdrawn
Lansoprazole	Lansoprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Investigational
Levodopa	The serum concentration of Levodopa can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Levofloxacin	The serum concentration of Levofloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved, Investigational
Levothyroxine	The serum concentration of Levothyroxine can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Lipoic Acid	Ferric 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
Lomefloxacin	The serum concentration of Lomefloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Magaldrate	Magaldrate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Withdrawn
Magnesium carbonate	Magnesium carbonate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Magnesium Hydroxide	Magnesium 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 oxide	Magnesium 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 Trisilicate	Magnesium Trisilicate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Methantheline	Methantheline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Methyldopa	The serum concentration of Methyldopa can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Metiamide	Metiamide can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Experimental
Minocycline	Minocycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Investigational
Moxifloxacin	The serum concentration of Moxifloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved, Investigational
Nalidixic Acid	The serum concentration of Nalidixic Acid can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Nizatidine	Nizatidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Norfloxacin	The serum concentration of Norfloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Ofloxacin	The serum concentration of Ofloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Olanzapine	Olanzapine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Investigational
Omeprazole	Omeprazole 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
Oxytetracycline	Oxytetracycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Vet Approved
Pancrelipase	Pancrelipase can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Pantoprazole	Pantoprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Pazufloxacin	The serum concentration of Pazufloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Investigational
Pefloxacin	The serum concentration of Pefloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Penicillamine	Ferric Carboxymaltose can cause a decrease in the absorption of Penicillamine resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Prulifloxacin	The serum concentration of Prulifloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Investigational
Rabeprazole	Rabeprazole can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Investigational
Ranitidine	Ranitidine can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Rosoxacin	The serum concentration of Rosoxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Roxatidine acetate	Roxatidine acetate can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Sodium glycerophosphate	Ferric 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 phosphate	Ferric Carboxymaltose can cause a decrease in the absorption of Sodium phosphate resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved
Sparfloxacin	The serum concentration of Sparfloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved
Temafloxacin	The serum concentration of Temafloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Withdrawn
Tetracycline	Tetracycline can cause a decrease in the absorption of Ferric Carboxymaltose resulting in a reduced serum concentration and potentially a decrease in efficacy.	Approved, Vet Approved
Triethylenetetramine	The serum concentration of Ferric Carboxymaltose can be decreased when it is combined with Triethylenetetramine.	Approved
Trovafloxacin	The serum concentration of Trovafloxacin can be decreased when it is combined with Ferric Carboxymaltose.	Approved, Withdrawn

Food Interactions

Not Available

References

Synthesis Reference

Not Available

General References

Not Available

External Links

Resource	Link
KEGG Drug	D08920
ChEMBL	CHEMBL2108597
Drugs.com	http://www.drugs.com/international/ferric-carboxymaltose.html

ATC Codes

Not Available

AHFS Codes

20:04.04

PDB Entries

Not Available

FDA label

Download (269 KB)

MSDS

Not Available

Clinical Trials

Phase	Status	Purpose	Conditions	Count
1	Completed	Treatment	Chronic Heart Failure (CHF)	1
1	Suspended	Treatment	Functional Iron Deficiency / ICU Anemia	1
2	Active Not Recruiting	Treatment	Iron Deficiency Anemia (IDA)	1
2	Completed	Treatment	Fibromyalgia / Iron Deficiency	1
2	Completed	Treatment	Restless Legs Syndrome (RLS)	2
2	Not Yet Recruiting	Supportive Care	Gastrointestinal Stromal Tumor With Neurogenic Differentiation / Malignant Neoplasms of Mesothelial and Soft Tissue	1
2	Not Yet Recruiting	Treatment	Iron-Deficiency	1
2	Recruiting	Supportive Care	Metastatic Colorectal Cancers	1
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, Systolic / Iron Deficiency	1
2	Recruiting	Treatment	Restless Legs Syndrome (RLS)	1
2	Terminated	Treatment	Iron-Deficiency Anemias / Thrombocytosis	1
2	Unknown Status	Treatment	Iron Deficiency Anemia (IDA)	2
2, 3	Terminated	Treatment	Iron-Deficiency Anemias / Postpartum Depression / Puerperal Disorders	1
3	Active Not Recruiting	Treatment	Iron Deficiency Anemia (IDA)	1
3	Active Not Recruiting	Treatment	Iron-Deficiency Anemias	1
3	Active Not Recruiting	Treatment	Restless Legs Syndrome (RLS)	1
3	Completed	Treatment	Anemias	10
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 (UC)	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 Fractures	1
3	Completed	Treatment	Impaired Renal Function / Iron Deficiency Anemia (IDA)	1
3	Completed	Treatment	Iron Deficiency	1
3	Completed	Treatment	Iron Deficiency Anemia (IDA)	1
3	Completed	Treatment	Iron-Deficiency Anemias	1
3	Completed	Treatment	Postpartum Anemia	1
3	Recruiting	Treatment	Anemias	1
3	Recruiting	Treatment	Cancer and Chemotherapy Related Anemia	1
3	Recruiting	Treatment	Heart Failure, Unspecified / Iron-Deficiency	1
3	Recruiting	Treatment	Iron Deficiency / Type 2 Diabetes Mellitus	1
3	Terminated	Treatment	Anemias / Chronic Heart Failure (CHF) / Iron Deficiency / Iron Deficiency Anemia (IDA)	1
3	Terminated	Treatment	Anemias / Heart Failure, Unspecified / Iron Deficiency	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	Completed	Treatment	Anemias / Heart Failure, Unspecified / Iron Deficiency	1
4	Completed	Treatment	Anemias / Iron Deficiency	1
4	Completed	Treatment	Anemias / Neoplasms, Colorectal	2
4	Completed	Treatment	Chronic Heart Failure (CHF) / Iron Deficiency	1
4	Completed	Treatment	Iron Deficiency Anemia (IDA) / Restless Legs Syndrome (RLS)	1
4	Completed	Treatment	Osteoarthritis of the Knees / Postoperative Anaemia	1
4	Completed	Treatment	Tiredness	1
4	Not Yet Recruiting	Treatment	Anemias	1
4	Not Yet Recruiting	Treatment	Heart Failure, Unspecified	1
4	Not Yet Recruiting	Treatment	Synovitis of osteoarthritis	1
4	Recruiting	Treatment	Anemia of Chronic Kidney Disease	1
4	Recruiting	Treatment	Anemias	1
4	Recruiting	Treatment	Heart Failure, Unspecified	1
4	Recruiting	Treatment	Heart Failure, Unspecified / Iron Deficiency	1
4	Recruiting	Treatment	Iron-Deficiency Anemias	1
4	Terminated	Treatment	Iron-Deficiency Anemias	1
4	Unknown Status	Treatment	Postoperative Anaemia	1
Not Available	Completed	Basic Science	Iron Deficiency	1
Not Available	Not Yet Recruiting	Treatment	Prognathic Surgery	1

Pharmacoeconomics

Manufacturers

Not Available

Packagers

Not Available

Dosage forms

Form	Route	Strength
Injection, solution	Intravenous	50 mg/mL

Prices

Not Available

Patents

Patent Number	Pediatric Extension	Approved	Expires (estimated)
US7612109	No	2004-02-05	2024-02-05	US
US7754702	No	2007-02-13	2027-02-13	US
US8895612	No	2007-01-08	2027-01-08	US

Properties

State

Solid

Experimental Properties

Not Available

Predicted Properties

Not Available

Predicted ADMET features

Not Available

Spectra

Mass Spec (NIST)

Not Available

Spectra

Spectrum Type	Description	Splash Key

Taxonomy

Classification

Not classified

Drug created on July 31, 2013 23:33 / Updated on July 23, 2017 12:16

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